Global Atlas of Medical Devices: A1B2 C3D4

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Global atlas of
medical devices
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Global atlas of
medical devices
2022
Global atlas of medical devices 2022
ISBN 978-92-4-006220-7 (electronic version)

ISBN 978-92-4-006221-4 (print version)
© World Health Organization 2022

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Contents
Acknowledgements .. .. .. .. .. vii
Acronyms and abbreviations .. .. .. viii
Preface .. .. .. .. .. .. .. ix
Methodology .. .. .. .. .. .. x
Sources of the country profile’s indicators .. xi
Country profiles . . . . . . . . . . . . . . . 1
Afghanistan - - - - - - 2 Burkina Faso - - - - - - 54
Albania - - - - - - - 4 Burundi - - - - - - - 56
Algeria - - - - - - - 6 Cambodia - - - - - - - 58
Andorra - - - - - - - 8 Cameroon - - - - - - 60
Angola - - - - - - - 10 Canada - - - - - - - 62
Antigua and Barbuda - - - - - 12 Cabo Verde - - - - - - 64
Argentina - - - - - - - 14 Central African Republic - - - - 66
Armenia - - - - - - - 16 Chad - - - - - - - 68
Australia - - - - - - - 18 Chile - - - - - - - 70
Austria - - - - - - - 20 China - - - - - - - 72
Azerbaijan - - - - - - - 22 Colombia - - - - - - - 74
Bahamas - - - - - - - 24 Comoros - - - - - - - 76
Bahrain - - - - - - - 26 Congo - - - - - - - 78
Bangladesh - - - - - - 28 Cook Islands - - - - - - 80
Barbados - - - - - - - 30 Costa Rica - - - - - - - 82
Belarus - - - - - - - 32 Côte d’Ivoire - - - - - - 84
Belgium - - - - - - - 34 Croatia - - - - - - - 86
Belize - - - - - - - 36 Cuba - - - - - - - 88
Benin - - - - - - - 38 Cyprus - - - - - - - 90
Bhutan - - - - - - - 40 Czechia - - - - - - - 92
Bolivia (Plurinational State of) - - - 42 Democratic People’s Republic of Korea - - 94
Bosnia and Herzegovina - - - - 44 Democratic Republic of the Congo - - 96
Botswana - - - - - - - 46 Denmark - - - - - - - 98
Brazil - - - - - - - 48 Djibouti - - - - - - - 100
Brunei Darussalam - - - - - 50 Dominica - - - - - - - 102
Bulgaria - - - - - - - 52 Dominican Republic - - - - - 104
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Ecuador - - - - - - - 106 Kenya - - - - - - - 180

Egypt - - - - - - - 108 Kiribati - - - - - - - 182
El Salvador - - - - - - 110 Kuwait - - - - - - - 184
Equatorial Guinea - - - - - 112 Kyrgyzstan - - - - - - - 186
Eritrea - - - - - - - 114 Lao People’s Democratic Republic - - 188
Estonia - - - - - - - 116 Latvia - - - - - - - 190
Eswatini - - - - - - - 118 Lebanon - - - - - - - 192
Ethiopia - - - - - - - 120 Lesotho - - - - - - - 194
Fiji - - - - - - - - 122 Liberia - - - - - - - 196
Finland - - - - - - - 124 Libya - - - - - - - - 198
France - - - - - - - 126 Lithuania - - - - - - - 200
Gabon - - - - - - - 128 Luxembourg - - - - - - 202
Gambia - - - - - - - 130 Madagascar - - - - - - 204
Georgia - - - - - - - 132 Malawi - - - - - - - 206
Germany - - - - - - - 134 Malaysia - - - - - - - 208
Ghana - - - - - - - 136 Maldives - - - - - - - 210
Greece - - - - - - - 138 Mali - - - - - - - - 212
Grenada - - - - - - - 140 Malta - - - - - - - 214
Guatemala - - - - - - - 142 Marshall Islands - - - - - - 216
Guinea - - - - - - - 144 Mauritania - - - - - - - 218
Guinea-Bissau - - - - - - 146 Mauritius - - - - - - - 220
Guyana - - - - - - - 148 Mexico - - - - - - - 222
Haïti - - - - - - - - 150 Micronesia (Federated States of) - - - 224
Honduras - - - - - - - 152 Monaco - - - - - - - 226
Hungary - - - - - - - 154 Mongolia - - - - - - - 228
Iceland - - - - - - - 156 Montenegro - - - - - - 230
India - - - - - - - - 158 Morocco - - - - - - - 232
Indonesia - - - - - - - 160 Mozambique - - - - - - 234
Iran (Islamic Republic of) - - - - 162 Myanmar - - - - - - - 236
Iraq - - - - - - - - 164 Namibia - - - - - - - 238
Ireland - - - - - - - 166 Nauru - - - - - - - 240
Israel - - - - - - - 168 Nepal - - - - - - - 242
Italy - - - - - - - - 170 Netherlands - - - - - - 244
Jamaica - - - - - - - 172 New Zealand - - - - - - 246
Japan - - - - - - - 174 Nicaragua - - - - - - - 248
Jordan - - - - - - - 176 Niger - - - - - - - 250
Kazakhstan - - - - - - 178 Nigeria - - - - - - - 252
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Niue - - - - - - - - 254 Spain - - - - - - - 328

North Macedonia - - - - - 256 Sri Lanka - - - - - - - 330
Norway - - - - - - - 258 Sudan - - - - - - - 332
Oman - - - - - - - 260 Suriname - - - - - - - 334
Pakistan - - - - - - - 262 Sweden - - - - - - - 336
Palau - - - - - - - 264 Switzerland - - - - - - 338
Panama - - - - - - - 266 Syrian Arab Republic - - - - - 340
Papua New Guinea - - - - - 268 Tajikistan - - - - - - - 342
Paraguay - - - - - - - 270 Thailand - - - - - - - 344
Peru - - - - - - - - 272 Timor-Leste - - - - - - 346
Philippines - - - - - - - 274 Togo - - - - - - - - 348
Poland - - - - - - - 276 Tonga - - - - - - - 350
Portugal - - - - - - - 278 Trinidad and Tobago - - - - - 352
Qatar - - - - - - - 280 Tunisia - - - - - - - 354
Republic of Korea - - - - - 282 Türkiye - - - - - - - 356
Republic of Moldova - - - - - 284 Turkmenistan - - - - - - 358
Romania - - - - - - - 286 Tuvalu - - - - - - - 360
Russian Federation - - - - - 288 Uganda - - - - - - - 362
Rwanda - - - - - - - 290 Ukraine - - - - - - - 364
Saint Kitts and Nevis - - - - - 292 United Arab Emirates - - - - - 366
Saint Lucia - - - - - - - 294 United Kingdom of Great Britain and
Northern Ireland - - - - - 368
Saint Vincent and the Grenadines - - - 296
United Republic of Tanzania - - - - 370
Samoa - - - - - - - 298
United States of America - - - - 372
San Marino - - - - - - 300
Uruguay - - - - - - - 374
Sao Tome and Principe - - - - 302
Uzbekistan - - - - - - 376
Saudi Arabia - - - - - - 304
Vanuatu - - - - - - - 378
Senegal - - - - - - - 306
Venezuela (Bolivarian Republic of) - - 380
Serbia - - - - - - - 308
Viet Nam - - - - - - - 382
Seychelles - - - - - - - 310
Yemen - - - - - - - 384
Sierra Leone - - - - - - 312
Zambia - - - - - - - 386
Singapore - - - - - - - 314
Zimbabwe - - - - - - - 388
Slovakia - - - - - - - 316
Slovenia - - - - - - - 318 Annex 1- Additional comments - - A1
Solomon Islands - - - - - - 320
Annex 2 - Overview of no-
Somalia - - - - - - - 322 menclature systems for medical
South Africa - - - - - - 324 devices in WHO member states - B1
South Sudan - - - - - - 326
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Acknowledgements
In order to respond to the World Health Assembly resolution 60.26 on health technologies, particularly medical
devices, WHO secretariat, Adriana Velazquez Berumen, Team lead for medical devices and in vitro diagnostics,
coordinated the work on the first Baseline country survey on medical devices (under the Global Initiative on
Health Technologies) as well as the resulting Global Atlas of medical devices in 2010. Since then, to keep the data
up-to-date, she coordinated various re-launches of the survey whose results were published as country profiles in
book form and/or digital form on the WHO website in 2015 and 2017 and this present publication on 2022. The
statistics are also found in the Global Health Observatory, where data has been updated after every edition. She
worked in 2021, under the guidance from Dr Clive Ondari director of the Health Product Policy and Standards
Department, and the leadership of Dr Mariangela Simao, Assistant Director General of the Access to Medicines
and Health Products Division.
WHO acknowledges and is most grateful to the consultants, country focal points in the Ministries of Health and
WHO staff at regional and country offices who dedicated their time and expertise to provide country data on
medical devices. The survey was managed by Ricardo X. Martínez with the support of Heike Hufnagel and Valeria
Montant. The analysis, evaluation, compilation, and verification of response data was coordinated and implemented
by Ricardo X. Martínez with the assistance of Heike Hufnagel, Lucero López, Lucia Jiménez, Juan J. López, David
López, Artiom Schepilov and Sebastián Losada.
The search for and retrieval of the answers to the survey in Member States was a collaborative effort of the appointed
health technology focal points and/or the the medical device country focal points. The update of the country focal
point contacts was possible thanks to the WHO regional advisers on health technologies, WHO health products
focal points, and WHO representatives and liaison officers.
Three desk-reviews in the medical device areas “health technology assessment“(HTA), “nomenclature system”, and
“regulatory agency” were accomplished in order to verify and complete the country data. They were coordinated by
Ricardo X. Martínez and executed by Lucia Jiménez, Juan J. López, David López, Artiom Schepilov, and Lucero López.
Jani Müller, senior researcher and board director of Health Technology Assessment International (HTAi), contributed
in the HTA-related survey 2021 answer verification as well as in the corresponding HTA desk-review. Thanks also to
the Economic Evaluation and Analysis, unit of WHO headquarters, specially to Andrew Mirelman, Kratu Goel, and
Tessa Edejer for their support in the HTA section.
Two country-consultations in September–November 2021 and April–May 2022, were done in order to verify the
validity of the collected data. The outcome of these consultations was collected and updated by Olga Pineda,
Daniela Rodriguez, and Lucia Jiménez.
Thanks to Riad F. Farah, Maurice Page, and Artiom Schepilov for their support in translating survey responses,
emails and other communication in Arabic, French, and Russian language respectively.
Thanks to WHO technical officers in the regional officers, as follows: Edith Annan, Diana Taguembou and Aissatou
Sarassa, Regional Office for Africa; Alexandre Lemgruber, Nilda Enriquez, Regional Office for the Americas/Pan
American Health Organization; Tifenn Lucile Humbert, Regional Office for Europe; Mohamad Wehbi, Regional Office
for the Eastern Mediterranean; Stephen Himley, Regional Office for South-East Asia; Jinho Shin, Regional Office for
the Western Pacific.
Thanks to Daniela Rodriguez for her support in publishing this document by helping with the clearance, website
creation, validation of indicator metadata and Jillian Reichenbach Ott for the data management.
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Acronyms and abbreviations

CSoMD21 Country survey on medical devices 2020-2021
FY21 Fiscal Year 2021
EMDN European Medical Device Nomenclature
GII Global Innovation Index
GNI gross national income
GHO WHO Global Health Observatory
GMDN Global Medical Device Nomenclature
HDI Human Development Index
HTA health technology assessment
IAEA International Atomic Energy Agency
ICT information, and communication technology
IDI ICT Development Index
ITU International Telecommunication Union
IHDI inequality adjusted Human Development Index
IVDs in vitro diagnostics
MOH Ministry of Health
MOR mortality
NCDs noncommunicable diseases
OECD Organisation for Economic Co-operation and Development
POP population
SDGs Sustainable Development Goals
UHC Universal Health Coverage
UMDNS Universal Medical Device Nomenclature System
UN United Nations
UN POP United Nations Population Division of the Department of Economic and Social Affairs
WB World Bank
WHO World Health Organization
WHS World Health Statistics
WIPO World Intellectual Property Organization
WPP World Population Prospects
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Preface
Health technologies are essential for a functioning health system. Medical devices in particular are crucial in the
prevention, diagnosis, and treatment of disease as well as patient monitoring. Recognizing this important role of
health technologies, the World Health Assembly adopted resolution WHA60.29 in May 2007.
To determine the key areas that require support for the development or improvement of health technology programs
in countries and regions, the first WHO Baseline country survey on medical devices was launched in February 2010
by the WHO Department of Essential Health Technologies and resulted in the first set of country profiles conveying
the situation of medical devices globally. The country profiles were updated with a re-launch of the survey in
November 2013 and since then, every 3 years, updates of the global medical device data have been published. In
2017 the Global Atlas of medical devices1 book was published containing 177 country profiles, an introduction to
the medical device topics covered by the survey, and the corresponding facts, figures, and maps. From November
2020 until March 2021, and then from September 2021 to May 2022, the latest complete re-launch of the survey was
carried out and its results are presented in this publication containing all 194 country profiles. It should be noted that
the COVID-19 situation alerted the challenges presented by lack of priority or basic medical devices.
This publication is intended for use as a reference by decision-makers in ministries of health, nongovernmental
organizations and academic institutions involved in health technology at the district, national, regional or global
levels. For a deeper understanding of the importance and standing in the health care domain of each of the survey’s
topics please refer to the document Global Atlas of medical devices - WHO medical devices technical series 2017
that addresses these in separate chapters.
1 Global atlas of medical devices - WHO medical devices technical series”, ISBN 978 -92 -4 -151231 -2 © World Health Organization 2017.
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Methodology
The 2020 re-launch of the 2010 Baseline country survey on medical devices was conceptualized and realized by
the medical devices team. The appointed health technology focal points of 177 Member States2 and more than 500
country contacts, as well as WHO contacts and related contacts in the 17 countries without appointed focal points,
were contacted by email in 4 different languages with a request to support and coordinate either the update of the
information already available in the previous atlas data or - in case of countries that had not answered the previous
surveys - their first participation in the survey. Additionally, the medical devices team with the help of consultants,
performed a web-based desk review of all countries to verify, update or newly include valid links to national websites
regarding regulation, health technology assessment, and nomenclature.
These efforts resulted in the final collection of all countries, either directly via nominated official health technology
focal points i.e. 179 countries or indirectly via specific medical device country focal points. Results were analyzed,
evaluated, compiled, and are now presented in this document in country profiles, together with additional information
regarding the global and national medical device situations. The country profiles incorporate facts indicating
the national status of medical devices in areas such as: medical device policies, regulations, incorporation, lists,
inventories, nomenclature, health technology assessment, management, and biomedical engineering resources.
The focus of the 2021 edition of the Global Atlas is to point out how the status of medical device topics supports or
hinders the accomplishment of the Sustainable Development Goals (SDGs) and supports the increased access to
priority medical devices (including in vitro diagnostics) for emergencies, well being and universal health coverage
(UCH).
During the Information sessions on nomenclature of medical devices, Member States requested to extend the open
consultation to review the Global Atlas . Therefore, consultations took place in 2021 and 2022 by posting in the
WHO medical devices newsletter and in the nomenclature page.
2 The countries‘ health technology focal points were nominated and their roles established in a two year effort upon the initiative of the WHO medical devices
team in 2010.
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Sources of the country profile’s

indicators
In the country profile there are four sections that contain indicators that may be taken from another source other
than the Country Survey of Medical Devices 2020-2021 (CSoMD21) consultation. Among these sources we have the
following: International Atomic Energy Agency: IAEA; Organisation for Economic Co-operation and Development
OECD; and WHO Global Health Observatory: GHO. Here we specified each of the indicators, as well as their definition,
details and sources.
Country indicators section

Total Population for all ages and both sexes (in millions) : corresponding population of year 2020 medium
estimates. World population prospects: the 2019 revision. POP/DB/WPP/Rev.2019/POP/ F01-1. United Nations,
Department of Economic and Social Affairs, Population Division (2019). World Population Prospects 2019, Online
Edition, accessed June 2021. UNDP WPP 2019 (2020 POP).
World Bank Income group classification: (WB Income Classification) The World Bank assigns the world’s economies
to four income groups: low, lower-middle, upper-middle, and high-income countries. The classifications are updated
each year on July 1 and are based on GNI per capita in current USD (using the Atlas method exchange rates) of
the previous year (i.e. 2021 in this case). In this publication the classification used corresponds to the Fiscal Year
of 2023: WB: FY23 (data year: 2021). . Accessed October 2022. (The link provided updates the year classification
each 1st of July, If it is the case you must refer to the historical WB income classification to find the fiscal year of
2023: FY23).
Life expectancy at birth (years): The average number of years of life expected by a hypothetical cohort of individuals
who would be subject during all their lives to the mortality rates of a given period. It is expressed as years. UN: WPP
2019, MORT (data year: 1990-2020). Accessed June 2022.
Under-five mortality rate (per 1000 live births) (SDG 3.2.1): Probability of dying by age 5 per 1000 live births.
WHO Global Health Observatory (GHO) data. UN-IGME, SDG 3.2.1 (data year: 2020). Accessed October 2022.
Probability of dying 30-70 of NCDs (SDG 3.4.1): probability of dying between age 30 and exact age 70 years from
any of cardiovascular disease, cancer, diabetes, or chronic respiratory disease. WHO Global Health Observatory
(GHO) data. WHO: GHO, SDG 3.4.1 (data year: 2019). Accessed October 2022.
Human Development Index (HDI): This a summary measure of average achievement in key dimensions of human
development: a long and healthy life (life expectancy at birth), being knowledgeable (education dimension measured
by mean of years of schooling for adults aged years and more and expected years of schooling for children of school
entering age), and have a decent standard of living (measured by gross national income per capita). Inequality
adjusted HDI (IHDI): adjusts the HDI for inequality in the distribution of each of the three dimensions across the
population. UNDP: HDR 2019/20, HDI and IHDI (data year: 2019).Accessed June 2022. HDI and IHDI technical notes
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Information, communication technology (ICT) Development Index (IDI): is a composite index combining eleven
indicators into one benchmark measure that serves to monitor and compare developments in ICT between countries
and over time. It is composed by 3 ICT related components: readiness (infrastructure, access), use (intensity), and
capability (skills). ITU: IDI 2017 (data year: 2017). Accessed June 2022. IDI methodology.
Service coverage Index (SDG 3.8.1): average coverage of essential services based on tracer interventions that
include reproductive, maternal, newborn and child health, infectious diseases, non-communicable diseases and
service capacity and access, among the general and the most disadvantaged population. WHO Global Health
Observatory (GHO) data. WHO: GHO, SDG 3.8.1 (data year: 2019). Accessed June 2022.
Percentage of the population with out-of-pocket health spending exceeding 10% or 25% of the household
expenditure/budget/income: (SDG 3.8.2). WHO Global Health Observatory (GHO) data. WHO: GHO, SDG 3.8.2,
10% (data year: latest 2010-18) and WHO: GHO, SDG 3.8.2, 25% (data year: latest 2010-18). Both accessed June 2022.
Global Innovation Index (GII): Is an annual ranking of countries by their capacity for, and success in, innovation. It
is computed by taking a simple average of the scores in two sub-indices, the Innovation Input Index and Innovation
Output Index, which are composed of five and two pillars respectively. Each of these pillars describes an attribute
of innovation. Each pillar is divided into three sub-pillars, each of which is composed of individual indicators, a total
of 80 indicators are in GII 2020 exploring a broad vision of innovation, including political environment, education,
infrastructure and business sophistication. WIPO: GII (data year: 2020). Accessed June 2022. GII Conceptual
Framework
High-technology exports (% of manufactured exports): Are products with high R&D intensity, such as in aerospace,
computers, pharmaceuticals, scientific instruments, and electrical machinery. UN-WB: HtE (data year: latest 2017-
19). Accessed June 2022.
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National health technology assessment unit section
Designated unit/department for health technology assessment (HTA): states if the country country has a
systematic formal process by which information is gathered to support healthcare decision-making at a national
level (options: Yes or No). Latest country data during the period 2015 to 2021 from one of the following sources:
WHO: HTA&HBP 2021 survey, WHO: HTA 2015 survey; and WHO CSoMD21. Both accessed June 2022.
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Official nomenclature system for medical devices: states if the country has reported having an official nomenclature
system for medical devices (options: Yes or No).
Type of nomenclature system for medical devices: states the reported type of official nomenclature system by the
country. The following seven nomenclature categories were taken into account: 1: Based on GMDN (Global Medical
Device Nomenclature); 2: Based on UMDNS (Universal Medical Device Nomenclature System); 3: Based on EMDN
(European Medical Device Nomenclature System) 4: Nationally developed 5: Based on more than one system; 6:
Other; 7: None.
“Based on” wording should be interpreted as includes original dataset or modified version.
Use of nomenclature system for medical devices states: the reported specific use of the official nomenclature
system by the country. The following five categories of specific uses were taken into account: 1: For regulatory
purposes; 2: For procurement purposes; 3: For regulatory and procurement purposes; 4: For various purposes;
5: Not specified.
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The first version of data collection related to medical devices, the Country Survey of Medical Devices (CSoMD),
was carried out during the 2010–2013 period. Thereafter, in the 2014–2017 and 2020–2021 periods, data relating to
medical devices was collected in what has now been referred to as the Country Survey (2020). The Global Atlas of
Medical Devices 2022 data collection was reviewed and updated if necessary, at the request of the Member States,
in an open consultation that lasted from September 2021 to May 2022, referred to as Nomenclature and Global
Atlas consultations (2021–2022).
Medical equipment section

Density of magnetic resonance imaging units (per million population): number of Magnetic Resonance (MRI) units
from the public and private sectors, per million population (UN: WPP 2019, POP (data year: 2020)). Latest country
data during the period 2013 to 2021 from one of the following sources: WHO CSoMD21, WHO: GHO, MD: MRI, and
OECD, HE database (2017-19). Both accessed June 2022.
Density of computed tomography units (per million population): number of Computed tomography (CT) scan
units from the public and private sectors, per million population (UN: WPP 2019, POP (data year: 2020)). Latest
country data during the period 2013 to 2021 from one of the following sources: WHO CSoMD21, WHO: GHO, MD: CT,
and OECD, HE database (2017-19). Both accessed June 2022.
Density of positron emission tomography units (per million population): number of Positron emission tomography
(PET) units from the public and private sectors, per million population (UN: WPP 2019, POP (data year: 2020).Latest
country data during the period 2013 to 2021 from one of the following sources: WHO CSoMD21, WHO: GHO, MD:
PET, and OECD, HE database (2017-19). Both accessed June 2022.
Density of gamma camera or nuclear medicine units (per million population): number of Gamma camera or
Nuclear medicine units from the public and private sectors, per million population (UN: WPP 2019, POP (data year:
2020)). Latest country data during the period 2013 to 2021 from one of the following sources: CSoMD21, WHO: GHO,
MD: GC-NC, and OECD, HE database (2017-19). Both accessed June 2022.
Density of mammographs (per million females aged between 50 and 69 years old): Number of mammographs
units from the public and private sectors, per million population (UN: WPP 2019, POP (data year: 2020). Latest
country data during the period 2013 to 2021 from one of the following sources: WHO CSoMD21 and WHO: GHO, MD:
MAM, and OECD, HE database (2017-19). Both accessed June 2022.
Density of radiotherapy units (per million population): number of radiotherapy units (RU) including the following:
circular and linear accelerators (LINAC), Radionuclide teletherapy units, Brachytherapy units, proton ion therapy or
particle accelerators, and X-Ray generators (as defined by IAEA); per million population (UN: WPP 2019, POP (data
year: 2020)). Latest country data during the period 2013 to 2021 from the latest available of the following sources:
WHO CSoMD21; WHO: GHO, RU and IAEA: DIRAC database (2017-21). Both accessed June 2022.
Medical devices workforce section

Number of biomedical/clinical engineers professionals in the country: Number of biomedical engineers (holding
the corresponding university degree). Latest country data during the period 2017 to 2021 from the latest available
of the following sources: CSoMD21; and WHO: GHO, HW. Accessed October 2022.
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C3D4
Afghanistan
Country indicators - WHO country information

Population 000s (rank):a 38,928 (37) Under-five mortality UHC - Service coverage
57.98 37
(per 1000 live births):d index (1-100):h
World Bank income group: b
Low
UHC - Population with
Life expectancy at birth (years):c Probability of dying household spending
14.6%
aged 30-70 yrs from 35.30% >10% (>25%) of
(2.0%)
the 4 major NCDs (%):e corresponding
income (%):i
Human Development
Years
Index (inequality 0.51 (—): Global innovation

— (—)
adjusted HDI): low index (rank):j
rank:f
High-technology
ICT Development
2 (159) exports (% of —
Index (rank):g
manufacture exports):k
National policy on health technology

Health technology (medical device) national policy: No
Policy is part of the National Health Program/Plan: No
Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: —
National lists of medical devices

National list of approved priority/essential medical devices, Approved devices lists comments
(including IVDs), for procurement or reimbursement: (...Annex 1):
Lists available: Yes, but it is only a recommendation —
Unit: —
Website: —
Nomenclature systems used for devices and tests: —
National list for different types of healthcare facilities Health care facilities lists comments
(hospitals, laboratories, etc) (...Annex 1):
Lists available: No —
Website - hospitals: —
Website - laboratories: —
National list for specific clinical interventions/emergencies: Specific lists comments (...Annex 1):
Website: —
e
National health technology assessment unit
Designated unit/department for health technology assessment (HTA):δ No HTA unit comments (...Annex 1):
The National HTA unit is not yet
HTA unit/department includes the assessment of medical devices: No established.
Unit/department: —
Website(s): —
Contact: — Email: —
Committee includes a biomedical or clinical engineer: —
National regulatory authority National regulatory comments

Presence of national authority responsible for regulating medical devices: Yes (...Annex 1):
Name of regulatory agency: General Directorate Pharmaceutical Affairs, Ministry of —
Public Health (MoPH).
Website(s): http://moph.gov.af/en
Contact: Mr. Abdul Hafiz Quraishi Email: —
Name(s) of other regulatory agency eg. for radiation equipment etc.: —
Other agency’s website: —
2
WHO Eastern Mediterranean Region
Afghanistan
A1B2 Medical device nomenclature system Nomenclature comments (...Annex 1):
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified —
Website: —
Medical device incorporation

Procurement
Policy or guideline: No Website: —
National level procurement: No Website: —
comments (...Annex 1):
Donations —
Technical specifications
Technical specifications to support procurement or donations: Yes
Publically available: No
Website: —
Density per
Medical equipment Total 1,000,000
population
Magnetic Resonance Imaging:α 3 0.1
Computerized Tomography Scanner:α 6 0.2
Positron Emission Tomography Scanner:α 0 0
Gamma camera or nuclear medicine:α 0 0
Mammograph:α,* 0 0
Radiotherapy:β 0 0
* Density per 1,000,000 females aged from 50-69 old.
Medical equipment management unit

Unit present: Yes Professionally trained biomedical/clinical engineers: Yes
Unit/Department: Radiology, Ministry of Public Health. Unit website: —
Contact name: Mr. Mirza Said Hashimi Contact email: moph.ird@gmail.com
Website with publically available technical specifications: —
Number of regional/state offices/units: 0
Inventories and medical equipment management software Software comments (...Annex 1):
Type of inventories available: National inventory for medical equipment —
Website: —
Use of management software: No Software name: —
Medical devices workforce

Number of biomedical/clinical engineers professionals in the country:γ <10
Contacts
National officer(s): WHO Country officer(s):
Name: Dr. Asheq Khan Sadaty Name: Dr. Dapeng Luo
Email: moph.dds@gmail.com Email: luod@who.int
Name: Mr. Mirza Said Hashimi Name: Dr. Najibullah Safi
Email: moph.ird@gmail.com Email: safin@who.int
General comments (...Annex 1): Concerning the HT national policy, it can be found the following document,
within the provided website: ley-18211-dec-5-2007 SNIS.pdf.
a UN: WPP 2019, POP (data year: 2020) h WHO: GHO, SDG 3.8.1 (data year: 2019) α WHO: GHO, ME; OECD, HE; CSoMD21
b WB: FY23 (data year: 2021) i WHO: GHO, SDG 3.8.2, 10% or 25% (data (data year: latest 2013-21)
c UN:WPP 2019, MORT (data year: 1990-2020) year: latest 2010-18) β WHO: GHO, RU; IAEA: DIRAC; CSoMD21
d UN-IGME, SDG 3.2.1 (data year: 2020) j WIPO: GII (data year: 2020) (data year: latest 2013-21)
e WHO: GHO, SDG 3.4.1 (data year: 2019) k UN-WB: HtE (data year: latest 2017-19) γ WHO: GHO, HW; CSoMD21 (data
f UNDP: HDR 2019/20, HDI and IHDI (data year: 2019) δ WHO: HTA&HBP 20/21 survey, HTA 2015, year: latest 2017-2021) 3
g ITU: IDI 2017 (data year: 2017) CSoMD21 (data year: latest 2015 or 2021) n/a not applicable/not available
Albania

9.84 62
Upper-Middle
16.7%
aged 30-70 yrs from 11.40% >10% (>25%) of
(5.0%)
income (%):i
Human Development
Years
Index (inequality 0.8 (0.71): Global innovation

27.1 (83)
adjusted HDI): high index (rank):j
rank:f
High-technology
ICT Development
5.1 (89) exports (% of 0.00%
Index (rank):g

Health technology (medical device) national policy: Yes
Policy is part of the National Health Program/Plan: Yes
Website: http://www.who.int/medical_devices/survey_resources/health_technology_national_policy_albania.pdf
https://shendetesia.gov.al/
Language(s): English and Albanian
Ministry of health responsible for health technology policy implementation: Unit for the Management of Medical Devices.

Unit: —
Website: —
Website - laboratories: http://akbpm.gov.al/publikime/
http://akbpm.gov.al/wp-content/uploads/2020/12/Regjistri-i-Barnave-Dhjetor-2020.xlsx
Website: —
e
There is not yet an HTA national unit but it
HTA unit/department includes the assessment of medical devices: No has been acknowledged at a political level
Unit/department: — by the MoH. There is a centralized system
for managing health products pricing and
Website(s): — reimbursement via the Ministry of Health,
Contact: — Email: — the National Agency for Drugs and Device,
and the Drug Price Commission.

Name of regulatory agency: National Agency for Drugs and Medical Devices —
(AKBPM).
Website(s): http://akbpm.gov.al/
https://shendetesia.gov.al/misioni-2/
Name(s) of other regulatory agency eg. for radiation equipment etc.: Agjencia Kombetare e Barnave dhe Pajisjeve
Mjekesore (National Agency for Drugs and Medical Devices).
Other agency’s website: http://akbpm.gov.al/?lang=en
4
WHO European Region
Albania
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed This italian nomenclature system CIVAB
Use: For procurement purposes comes with the Inventory system called
CLINGO.
Website: —

Procurement
Policy or guideline: Yes Website: —
National level procurement: Yes Website: —
Donations It exists the National Policy for
Policy or guideline: Yes Website: — management of medical devices in
Albania. The procurement of medical
Technical specifications devices at national levels is done partially.
Technical specifications to support procurement or donations: No
Publically available: —
Website: —
Density per
population
Mammograph:α,* 18 54.4
Radiotherapy:β 6 2.08

Unit/Department: Unit for the Management of Medical Devices. Unit website: —
Contact name: Ms. Ledina Picari Contact email: lpicari@moh.gov.al
Type of inventories available: National inventory for medical equipment The inventory system is called CLINGO.
The National Biomedical Centre manages
Website: — the system. Each hospital (13 regional
Use of management software: Yes Software name: Clingo. hospitals are involved) is in charge of
adding their own data. It doesn’t cover
all the hospitals and other public health
institutions.
Number of biomedical/clinical engineers professionals in the country:γ 55
Contacts
Name: — Name: Dr. Gerald Rockenschaub
Email: — Email: rockenschaubg@who.int
Name: Ms. Ledina Picari Name: —
Email: lpicari@moh.gov.al Email: —
General comments (...Annex 1): Concerning the HT national policy, the following document was provided:
http://www.who.int/medical_devices/survey_resources/health_technology_national_policy_albania.pdf
Algeria

22.68 75
Lower-Middle
aged 30-70 yrs from 13.90% >10% (>25%) of — (—)
income (%):i
Human Development
Years

19.5 (121)
rank:f
High-technology
ICT Development
4.7 (102) exports (% of 1.00%
Index (rank):g

Website: http://www.sante.gov.dz/communiques/82-documentation/455-programmes-d-importation-des-produits-pharmaceutiques.
html
Language(s): Français
Ministry of health responsible for health technology policy implementation: Direction Générale de la Pharmacie.

Unit: —
Website: —
Website: —
e
Adopted EMA (European Medicines
HTA unit/department includes the assessment of medical devices: No Agency) and ICH (International Council
Unit/department: — for Harmonisation for Pharmaceuticals)
guidelines. Inspector General Office
Website(s): — performs health economics HTA. Within
Contact: — Email: — the MoH HTA is focused on pharmaceutics
but not in medical devices.

Name of regulatory agency: Ministère de la santé, de la Population et de la Réforme —
Hospitalière.
Website(s): www.sante.gov.dz
Contact: Dr. Hamou Hafed Email: dgpharmacie@sante.dz
Name(s) of other regulatory agency eg. for radiation equipment etc.: Algerian
Atomic Energy Commission (Comena).
Other agency’s website: https://www.aps.dz/en/algeria/tag/Atomic%20Energy%20Commission
6
WHO African Region
Algeria
Website: —

Procurement
Donations —
Website: —
Density per
population
Magnetic Resonance Imaging:α n/a n/a
Computerized Tomography Scanner:α n/a n/a
Positron Emission Tomography Scanner:α n/a n/a
Gamma camera or nuclear medicine:α n/a n/a
Mammograph:α,* n/a n/a

Unit present: — Professionally trained biomedical/clinical engineers: No
Unit/Department: Sous direction de l’enregistrement des produits pharmaceutiques. Unit website: www.sante.gov.dz
Contact name: Dr. Soumia Yahiaoui Contact email: bensoumi20@yahoo.com
Number of regional/state offices/units: —
Type of inventories available: — —
Website: —

Contacts
Name: — Name: Dr. Bla François Nguessan
Email: — Email: nguessanf@who.int
Name: Dr. Soumia Yahiaoui Name: —
Email: bensoumi20@yahoo.com Email: —
General comments (...Annex 1): —
Andorra

Population 000s (rank):a 77 (184) Under-five mortality UHC - Service coverage
2.53 77
High
aged 30-70 yrs from — >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
adjusted HDI): very high index (rank):j
rank:f
High-technology
ICT Development
7.7 (30) exports (% of 28.50%
Index (rank):g

Health technology (medical device) national policy: —
Policy is part of the National Health Program/Plan: —
Website: —
Language(s): —

Lists available: — —
Unit: —
Website: —
Website: —
e
There are identified HTA activities but not
HTA unit/department includes the assessment of medical devices: No a national unit.
Website(s): —

Presence of national authority responsible for regulating medical devices: — (...Annex 1):
Name of regulatory agency: — —
Website(s): —
8
WHO European Region
Andorra
C3D4 Official nomenclature system for medical devices: — Type: — Use: — —
Website: —

Procurement
Policy or guideline: — Website: —
National level procurement: — Website: —
Donations —
Technical specifications to support procurement or donations: —
Website: —
Density per
population
Radiotherapy:β n/a n/a


Unit present: — Professionally trained biomedical/clinical engineers: —
Unit/Department: — Unit website: —
Contact name: — Contact email: —
Website: —
Use of management software: — Software name: —

Number of biomedical/clinical engineers professionals in the country:γ —
Contacts
Name: — Name: —
Email: — Email: —
Name: — Name: —
Angola

71.47 39
Lower-Middle
aged 30-70 yrs from 22.30% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
adjusted HDI): medium index (rank):j
rank:f
High-technology
ICT Development
1.9 (160) exports (% of 5.80%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Lists available: Yes —
Website: —
e
—
HTA unit/department includes the assessment of medical devices: No
Website(s): —

Name of regulatory agency: Agência Reguladora de Medicamentos e Tecnologias June 4, 2021: With Presidential
de Saúde (ARMED) Decree 136/21 the extinction of the
Direcção Nacional de Medicamentos e
Website(s): — Equipamentos is announced and the
Contact: Dr. Boaventura Moura Email: boaventura.ao@gmail.com Regulatory Agency for Medicines and
Health Technologies (ARMED) is created,
Name(s) of other regulatory agency eg. for radiation equipment etc.: — which will have its headquarters in Luanda,
Angola and will be supervised by the
Ministry of Health.
10
WHO African Region
Angola
Website: —

Procurement
Donations —
Website: —
Density per
population

Contact name: Mr. Elisio de Carvalho Contact email: oisile2000@yahoo.com.br
Website: —

Contacts
Name: Mr. Elisio de Carvalho Name: Dr. Djamila Khady Cabral
Email: oisile2000@yahoo.com.br Email: cabrald@who.int
Name: — Name: —
Antigua and Barbuda

6.39 72
High
aged 30-70 yrs from 17.60% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
5.7 (76) exports (% of 0.60%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
Designated unit/department for health technology assessment (HTA):δ — HTA unit comments (...Annex 1):
—
Website(s): —

Presence of national authority responsible for regulating medical devices: No (...Annex 1):
Website(s): —
12
WHO Region of the Americas
Antigua and Barbuda

Website: —

Procurement
Donations —
Website: —
Density per
population

Type of inventories available: None —
Website: —

Contacts
Name: Mr. St. Clair A. Soleyn Name: Dra. Amalia Del Riego
Email: stclairsoleyn@gmail.com Email: delriegoa@paho.org
Name: — Name: Dr. Cecilia Acuna
Email: — Email: acunamar@paho.org
Argentina

8.56 73
Upper-Middle
aged 30-70 yrs from 15.70% >10% (>25%) of — (—)
income (%):i
Human Development
0.85
Years
Index (inequality Global innovation

(0.73): 28.3 (80)
adjusted HDI): index (rank):j
very high
rank:f
High-technology
ICT Development
6.8 (51) exports (% of 5.20%
Index (rank):g

Website: https://www.argentina.gob.ar/ anmat
Language(s): Español
Ministry of health responsible for health technology policy implementation: Secretaría de Calidad en Salud - Ministerio de
Salud

Lists available: Yes Existe una base de datos que contiene a
las tecnologías sanitarias (denominados
Unit: Instituto Nacional de Productos Médicos - ANMAT productos médicos) registradas y
disponibles en el sitio -ver tercera liga web-
Website: https://www.argentina.gob.ar/anmat (accesible con colocar nombre génerico
https://helena.anmat.gob.ar/Boletin/ de producto (por ej: apósito) o con su
http://www.anmat.gov.ar/boletin_anmat/ principal.asp identificación (Nº de PM).
Lists available: Yes Cirugía, diagnóstico por imágenes,
laboratorio, terapia intensiva.
Website - hospitals: https://www.argentina.gob.ar/sssalud/hospitales
Website - laboratories: https://helena.anmat.gob.ar/Boletin/
http://www.anmat.gov.ar/ boletin_anmat/principal.asp
Lists available: Yes Actualmente existen lineamientos para
la elaboración de guías. Disponible en la
Website: https://www.argentina.gob.ar/salud/calidadatencionmedica segunda página web proporcionada.
e
Designated unit/department for health technology assessment (HTA):δ Yes HTA unit comments (...Annex 1):
In 2018, by Ministerial Resolution of Health
HTA unit/department includes the assessment of medical devices: Yes No. 623, the National Commission for
Unit/department: Administración Nacional de Medicamentos, Alimentos y the Evaluation of Health Technologies
(CONETEC) was created within the scope
Tecnología Médica (ANMAT) - Instituto Nacional de Productos Médicos of the Ministry of Health, dependent on its
Website(s): https://www.argentina.gob.ar/noticias/sobre-los-procesos-de-control-de- General Coordination Unit.
dispositivos-medicos
http://www.anmat.gov.ar/webanmat/normativas_productosmedicos_cuerpo.asp
http://www.iecs.org.ar
https://www.argentina.gob.ar/salud/conetec
Contact: Manuel Donato Email: farmdonatomanuel@gmail.com

Name of regulatory agency: Administración Nacional de Medicamentos, Alimentos —
y Tecnología Médica (ANMAT) - Instituto Nacional de Productos Médicos
Website(s): https://www.argentina.gob.ar/anmat/regulados/productos-medicos
Contact: Lic. Andrea Bodnar Email: andrea.bodnar@anmat.gob.ar
Name(s) of other regulatory agency eg. for radiation equipment etc.: Autoridad Regulatoria Nuclear (ARN)
14 Other agency’s website: https://www.argentina.gob.ar/arn
Argentina
C3D4 Official nomenclature system for medical devices: Yes Type: Based on UMDNS The Administración Nacional de
Use: For regulatory purposes Medicamentos Alimentos y Tecnología
Médica (ANMAT), reported the use of the
Website: — Universal Medical Device Nomenclature
System (UMDNS) for regulatory purposes
of the medical devices in this country
Procurement
Policy or guideline: Yes Website: http://www.anmat.gov.ar/webanmat/productos_
medicos/recomendaciones_compraprod.medicos.asp Medical device incorporation
National level procurement: Yes Website: http://www.anmat.gov.ar/webanmat/
For procurement of medical devices at
productos_medicos/recomendaciones_compraprod.me dicos.asp national level we use the: “lista licitaciones”.
Donations
Policy or guideline: Yes Website: https://www.argentina.gob.ar/anmat/regulados/
productosmedicos/requisitos-para-el-ingreso-al-pais-de-productos-donados
Publically available: Yes
Website: https://www.argentina.gob.ar/anmat/regulados/productosmedicos/requisitos-para-el-ingreso-al-pais-de-productos-
donados
Density per
population


Unit/Department: Unidad Coordinadora de Evaluación y Ejecución de Tecnologías en Salud.
Unit website: https://www.argentina.gob.ar/anmat
Contact name: Dra. Analía del Carmen Amarilla Contact email: pngc@msal.gov.ar
Website with publically available technical specifications: https://www.argentina.gob.ar/anmat
Website: —

Contacts
Name: Dra. Analia del Carmen Amarilla Name: Dr. Eva Jané Llopis
Email: aamarilla@msal.gov.ar Email: janellopis@paho.org
Name: — Name: Dra. Sonia Quezada
Email: — Email: quezadas@paho.org
General comments (...Annex 1): The MoH wants to push awareness/surveillance about health technology quality,
technical specifications, etc.
Armenia

10.94 69
Upper-Middle
16.1%
aged 30-70 yrs from 19.90% >10% (>25%) of
(4.9%)
income (%):i
Human Development
Years

32.6 (61)
rank:f
High-technology
ICT Development
5.8 (75) exports (% of 9.80%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
Informing decisions of the cited institutions
HTA unit/department includes the assessment of medical devices: Yes are not specifically HTA. Alternative email:
Unit/department: Health Project Implementation Unit and Scientific Centre of Drug info@healthpiu.arm.
and Medical Technology Expertise.
Website(s): https://healthpiu.am/
http://www.pharm.am/index.php/en/aboutus
Contact: Mr. Armen Madantsyan Email: healthpiu@gmail.com

Name of regulatory agency: Ministry of Health (MoH). “National Institute of Metrology”;
Website(s): https://www.moh.am/#3/27 National Institute of Standards”;
“ArmAtomInspection”; and “Scientific
Contact: Mr. Armen Karapeyan Email: akarapetyan@moh.am Center of Drug and Medical Technology
Name(s) of other regulatory agency eg. for radiation equipment etc.: Armenian Expertise”.
Nuclear Regulatory Authority (ANRA).
Other agency’s website: http://www.anra.am/index.aspx
http://www.pharm.am/index.php/en/
16
WHO European Region
Armenia
Website: —

Procurement
Donations The technical specifications are developed
Policy or guideline: No Website: — by the Health Project Implementation Unit
(HPIU) biomedical engineer in cooperation
Technical specifications with international consultants.
Website: —
Density per
population
Gamma camera or nuclear medicine:α 4 1.34

Unit/Department: Health Project Implementation Unit (HPIU). Unit website: http://www.pharm.am/
Contact name: Mr. Armen Madantsyan Contact email: Healthpiu@gmail.com
Website with publically available technical specifications: http://www.pharm.am/attachments/article/183/Appendix_2_%20
Notice%20to%20Applicants_eng.pdf
http://www.pharm.am/index.php/en/orders/5472-order-of-minister-of-health-of-the-republic-of-armenia-n02-n-of-january-21-2020-
on-approval-of-the-requirements-of-labeling-and-packaging-for-medicinal-products-pharmaceutical-substances-herbal-raw-materials-
investigational-medicinal-products-as-well-as-f
Website: http://www.pharm.am/

Contacts
Name: Mr. Armen Madantsyan Name: Dr. Jihane F. Tawilah
Email: healthpiu@gmail.com Email: tawilahj@who.int
Name: — Name: —
Email: Healthpiu@gmail.com Email: —
Australia

3.7 87
High
3.7%
aged 30-70 yrs from 8.60% >10% (>25%) of
(0.5%)
income (%):i
Human Development
0.94
Years

(0.87): 48.4 (23)
very high
rank:f
High-technology
ICT Development
8.2 (14) exports (% of 21.50%
Index (rank):g

Website: —
Language(s): —

Lists available: — Australian Register of Therapeutic Goods
(ARTG) – marketing approval and used to
Unit: — guide procurement in national and state/
territory processes
Website: www.tga.gov.au/australian-register-therapeutic-goods
Prostheses List of implanted medical
Nomenclature systems used for devices and tests: — devices for private patients -
Nomenclature systems used for devices and tests: GMDN
Website: —
e
The Therapeutic Goods Administration
HTA unit/department includes the assessment of medical devices: Yes (TGA), the Medical Services Advisory
Unit/department: Pharmaceutical Benefits Advisory Committee / Medical Committee (MSAC), the Pharmaceutical
Advisory Committee (PBAC), and the
Services Advisory Committee / Prostheses List Advisory Prostheses List Advisory Committee
Committee / Therapeutic Goods Administration. Committees including the (PLAC) perform Health Technology
Advisory Committee on Medical Devices (ACMD) Assessment (HTA) processes to provide
advice to the Australian Government
Website(s): http://www.msac.gov.au/internet/msac/publishing.nsf/Content/Factsheet-02 Department of Health.
https://www1.health.gov.au/internet/hta/publishing.nsf/Content/pbs-1
https://www1.health.gov.au/internet/hta/publishing.nsf/Content/mbs-1
https://www1.health.gov.au/internet/hta/publishing.nsf/Content/prostheses-1
Contact: — Email: hta@health.gov.au; devices@tga.gov.au
Committee includes a biomedical or clinical engineer: Yes

Name of regulatory agency: Australian Therapeutic Goods Administration (TGA). —
Website(s): http://www.tga.gov.au/medical-devices-ivds
Contact: Tracey Duffy Email: devices@tga.gov.au
Name(s) of other regulatory agency eg. for radiation equipment etc.: Australian
Radiation Protection and Nuclear Safety Agency (ARPANSA).
Other agency’s website: https://www.arpansa.gov.au/
18
WHO Western Pacific Region
Australia
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN The use of GMDN is a legal mandatory
Use: Therapeutic goods regulation (market authorisation) and procurement purposes requirement for devices supplied in
Australia, including IVDs.
by Government and non-Government entities and hospitals
Website: www.tga.gov.au

Procurement
Policy or guideline: National Medical Stockpile, National, State and Territory
Governments Website: — Medical device incorporation
—
Donations
Publically available: Government procurement websites at national and state/
territory levels
Website: —
Density per
population


Type of inventories available: — The National Product Catalogue provides
an inventory input to a number of
Website: — hospital procurement and equipment
Use of management software: — Software name: — managements systems. Also, various
systems are used by public and private
hospitals
Contacts
Name: Mr. Chris Bedford Name: —
Email: chris.bedford@health.gov.au Email: —
Name: — Name: —
General comments (...Annex 1): Australia’s health system policy and delivery is at both a national and state/
territory level. All medical devices must be included in the Australian Register of Therapeutic Goods.
Austria

3.62 82
High
aged 30-70 yrs from 10.40% >10% (>25%) of — (—)
income (%):i
Human Development
0.92
Years

(0.86): 50.1 (19)
very high
rank:f
High-technology
ICT Development
8 (21) exports (% of 11.50%
Index (rank):g

Website: https://www.sozialministerium.at/en.html
Language(s): German

Unit: Hauptverband der österreichischen Sozialversicherungsträger.
Website: —
Website - hospitals: https://www.sozialministerium.at/public.html
Website - laboratories: https://www.sozialministerium.at/public.html
Lists available: Yes Österreichischer Strukturplan Gesundheit
(up mentioned link) and various guidelines
Website: https://www.sozialministerium.at/public.html of the medical societies, internal guidelines
of the hospitals, etc. Also, there is the
Austrian Influenza Pandemic Plan.
e
Only for the hospital benefit catalogue
HTA unit/department includes the assessment of medical devices: Yes there is a national HTA process in place,
Unit/department: GOEG/BIQG but not for drugs. It is expected that it will
be a process in place in the next 1-2 years.
Website(s): http://www.goeg.at
https://aihta.at
http://www.sozialversicherung.at
Contact: Ms. Eva Kernstock Email: eva.kernstock@goeg.at

Name of regulatory agency: Austrian Medicines and Medical Devices Agency —
(BASG).
Website(s): http://www.basg.gv.at/en/medical-devices/
Contact: Dr. Martin Renhardt Email: martin.renhardt@bmg.gv.at
Name(s) of other regulatory agency eg. for radiation equipment etc.: Austrian
Federal Office for Safety in Health Care/Bundesamt für Sicherheit im Gesundheitswesen (BASG); International Atomic
Energy Agency (IAEA).
Other agency’s website: https://www.basg.gv.at
https://www-pub.iaea.org/MTCD/Publications/PDF/CSPS-7-P.pdf
20
WHO European Region
Austria
C3D4 Official nomenclature system for medical devices: Yes Type: Based on EMDN Use: As per regulation 2017/45 on medical
For regulatory purposes devices and Regulation (EU) 2017/746, the
EU Member States Competent Authorities
Website: https://goeg.at/Medizinprodukteregister of MD representatives (of both the
national MoH and the national agencies)
of the MDCG, have opted for the publicly
Medical device incorporation available, accessible and transparent
nomenclature named European Medical
Procurement Device Nomenclature (EMDN)
Policy or guideline: Yes Website: http://www.hauptverband.at/
Donations The procurement is done with internal
Policy or guideline: Yes Website: — guidelines of the Hauptverband, insurance
funds, hospitals, Bundesbeschaffungs
Technical specifications GmbH, etc.
Website: —
Density per
population
Positron Emission Tomography Scanner:α 24 2.66

Unit/Department: Abteilung Medizinprodukte within MoH (BMSPGK). Unit website: http://www.bmg.gv.at
Contact name: Dr. Martin Renhardt Contact email: martin.renhardt@bmg.gv.at
Website with publically available technical specifications: https://www.sozialministerium.at/Themen/Gesundheit/Medizin-und-
Gesundheitsberufe/Medizin/Medizinprodukte/Erlaesse-und-Richtlinien-im-Bereich-Medizinprodukte.html
Type of inventories available: National inventory only for high cost technologies There are various software for the
maintenance and inspection of medical
(such as MRI, CT or PET scanners) devices in the hospital. Additionally,
Website: https://www.sozialministerium.at/ there is the implementation of a National
Plan for high-cost technologies called:
Use of management software: Yes Software name: Various: MTECS, Visual FM, SAP, “Großgeräteplan”.
etc.

Contacts
Name: Dr. Martin Renhardt Name: —
Email: martin.renhardt@bmg.gv.at Email: —
Name: — Name: —
Azerbaijan

19.39 65
Upper-Middle
aged 30-70 yrs from 27.20% >10% (>25%) of — (—)
income (%):i
Human Development
0.76
Years

(0.68): 27.2 (82)
high
rank:f
High-technology
ICT Development
6.2 (65) exports (% of 5.00%
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Health Organization Department.

Unit: Medical Technical Department of the Innovation and Supply Centre.
Website: —
Website: —
e
The HTA activities in pharmaceutics are
HTA unit/department includes the assessment of medical devices: Yes not specifically for medical devices.
Website(s): https://www.isim.az/en/main
Contact: Mr. Kerimov Ramiz Talat Email: kerimov62@hotmail.com

Name of regulatory agency: Analytical Expertise Center (MMA). —
Website(s): http://www.pharma.az/
Name(s) of other regulatory agency eg. for radiation equipment etc.: State Agency
for Normal and Radiological Activity Regulation (Ministry of Emergency Situations
of the Republic of Azerbaijan).
Other agency’s website: https://www.nuve.fhn.gov.az/organizations.php?aze-7
22
WHO European Region
Azerbaijan
Website: —

Procurement
Donations The Procurement guidelines are under
Policy or guideline: Yes Website: https://apps.who.int/iris/bitstream/ development. For donations guidelines
the WHO are the ones used. The
handle/10665/44568/9789241501408_eng.pdf?sequence=1 corresponding technical specifications are
Technical specifications under the responsibility of the Innovation
and Supply Centre.
Website: —
Density per
population

Unit/Department: Innovation and Supply Centre. Unit website: —
Contact name: Mr. Ramiz Kerimov Contact email: kerimov62@hotmail.com
Website: —

Contacts
Name: Mr. Kerimov Ramiz Talat Name: Dr. Fatos Hande Harmanci
Email: kramiz62@hotmail.com Email: harmancih@who.int
Name: Mr. Ramiz Kerimov Name: —
Email: kerimov62@hotmail.com Email: —
Bahamas

12.26 70
High
2.7%
aged 30-70 yrs from 19.90% >10% (>25%) of
(0.2%)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
6.5 (57) exports (% of 2.00%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Lists available: No There are no lists recommending health
technology for any of the above.
Website: —
e
—
Website(s): —

Name of regulatory agency: Ministry of Health (MoH). —
Website(s): https://www.bahamas.gov.bs
24
Bahamas
Website: —

Procurement
National level procurement: Yes Website: http://www.phabahamas.org/
Donations The Public Hospitals Authority, the
Policy or guideline: No Website: — corporate entity of the Ministry of Health, is
responsible for managing the three Public
Technical specifications Hospitals within the Bahamas. It uses the
Technical specifications to support procurement or donations: No services of the ECRI Institute to assist in
the procurement of medical devices.
Website: —
Density per
population

Unit/Department: Supplies Management Agency. Unit website: —
Contact name: Mr. Audley Bain Contact email: abain1@pmh.phabahamas.org
Website: —

Contacts
Name: Dr. Anthone Ward Name: Dr. Eldonna Boisson
Email: award@phabahamas.org Email: boissoel@paho.org
Name: — Name: Dr. Gabriel Vivas
Email: — Email: vivasfgab@paho.org
Bahrain

6.76 71
High
aged 30-70 yrs from 16.10% >10% (>25%) of — (—)
income (%):i
Human Development
Years

28.4 (79)
rank:f
High-technology
ICT Development
7.6 (31) exports (% of 0.40%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
Website(s): —

Name of regulatory agency: National Health Regulatory Authority, Kingdom of —
Bahrain.
Website(s): https://www.nhra.bh/
https://www.moh.gov.bh/?lang=en
Name(s) of other regulatory agency eg. for radiation equipment etc.: Ministry of Health; Supreme Council for Environment.
Other agency’s website: https://www.moh.gov.bh/?lang=en; ECD:
https://www.sce.gov.bh/en/CommunicationGuide?cms=iQRpheuphYtJ6pyXUGiNqgEU69X91IJi
26
Bahrain
C3D4 Official nomenclature system for medical devices: Yes Type: More than one system It is needed the GMDN code for
Use: For regulatory and procurement purposes registration of medical devices, as well as
the HS code.
Website: https://www.nhra.bh/Departments/MDR/
https://www.nhra.bh/

Procurement
Donations —
Website: —
Density per
population

Website: —

Contacts
Name: — Name: Dr. Tasnim Atatrah
Email: — Email: atatraht@who.int
Name: — Name: —
Bangladesh

29.1 51
Lower-Middle
24.7%
aged 30-70 yrs from 18.90% >10% (>25%) of
(9.5%)
income (%):i
Human Development
0.63
Years

(0.48): 20.4 (116)
medium
rank:f
High-technology
ICT Development
2.5 (147) exports (% of —
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Health Services Division.

Unit: Directorate General of Drug Administration (DGDA).
Website: https://www.dgda.gov.bd/ index.php
Nomenclature systems used for devices and tests: National.
Website - laboratories: http://dgda.gov.bd/index.php/2013-03-31-05-16-29/registered-
medical-device-list/1102-list-of-registered-medical-device-for-import/file
https://www.dgda.gov.bd/ index.php/ information-center/ guidance-documents/
1135-medical-device-registration-guideline- 2015
Website: —
e
—
Website(s): —

Name of regulatory agency: Directorate General of Drug Administration (DGDA). Ms. S. M. Sabrina Yesmin is the Assistant
Website(s): https://www.dgda.gov.bd/ Director of DGDA.
Contact: Ms S. M. Sabrina Yesmin Email: sabrinayesmin22@gmail.com; sabrina@dgda.
gov.bd
Name(s) of other regulatory agency eg. for radiation equipment etc.: Bangladesh
Atomic Energy Regulatory Authority - Government of the People’s Republic of Bangladesh; National Electro-Medical
Equipment Maintenance Workshop and Training Center-Ministry of Health and Family Welfare.
Other agency’s website: http://nememw.gov.bd/
http://www.baera.gov.bd/
28
WHO South-East Asia Region
Bangladesh
Website: —

Procurement
Policy or guideline: Yes Website: http://www.cptu.gov.bd/default.aspx
https://cptu.gov.bd/index.html Medical device incorporation
National level procurement: Yes Website: http://www.cptu.gov.bd/default.aspx
Technical specifications are not publically
https://cptu.gov.bd/procurement-policy-and-procedure-documents.html available.
Donations
Website: https://cptu.gov.bd/index.html
Density per
population

Type of inventories available: — Central Medical Stores Depot, Tejgaon,
Dhaka-1208. Dhaka has all the data in this
Website: — regards.

Contacts
Name: Mr. Salah Uddin Name: Dr. Bardan Jung Rana
Email: salahuddin733@yahoo.com Email: ranab@who.int
Name: — Name: —
Barbados

12.25 74
High
16.4%
aged 30-70 yrs from 16.00% >10% (>25%) of
(3.8%)
income (%):i
Human Development
0.81
Years

(0.68): — (—)
very high
rank:f
High-technology
ICT Development
7.3 (34) exports (% of 13.70%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
HTA activities have been identified, but
HTA unit/department includes the assessment of medical devices: No there is not a national unit.
Website(s): —

Website(s): —
30
Barbados
Website: —

Procurement
Donations Procurement queries, comments, and
Policy or guideline: No Website: — information should be addresses to the
Chief Supply Officer (email: joness@gob.
Technical specifications bb).
Website: —
Density per
population
Magnetic Resonance Imaging:α 0 0

Type of inventories available: — There is not a national inventory
but the Queen Elizabeth Hospital
Website: — Engineering Services maintains an
Use of management software: Yes Software name: Equipment Management inventory of high-cost technologies
and medical equipment; thus, there is
Software. an institutional inventory there. Also,
all the polyclinics keep institutional
inventory for medical equipment only.
Medical devices workforce The institutional inventories at the hospital
and the polyclinics are audited annually.
Number of biomedical/clinical engineers professionals in the country:γ <10 Additionally, the Equipment management
software is currently being installed at the
Queen Elizabeth Hospital.
Contacts
Name: Mr. Dwayne Smith Name: Dra. Amalia Del Riego
Email: lordmonkman@yahoo.com Email: delriegoa@paho.org
Name: Dr. Joy St. John Name: Dr. Cecilia Acuna
Email: cmo@health.gov.bb Email: acunamar@paho.org
General comments (...Annex 1): Concerning the Healthcare Infrastructure section: there are many single and
grouped medical centres and general practice clinics/offices which perform primary care that includes emergency
services. Some medical centres of the private sector perform secondary care services as well.
Belarus

2.91 74
Upper-Middle
9.2%
aged 30-70 yrs from 23.80% >10% (>25%) of
(0.7%)
income (%):i
Human Development
0.82
Years

(0.77): 31.3 (64)
very high
rank:f
High-technology
ICT Development
7.6 (32) exports (% of 4.30%
Index (rank):g

Website: http://minzdrav.gov.by/en/dlya-spetsialistov/meditsinskie-izdeliya/
https://rceth.by/ru/Departments/Med/Documents?orderby=name&dir=desc
Language(s): Russian

Lists available: Yes Documents: N° “2007 ” and N° “458” in
the specified website.
Unit: Department of Medical Technology of the Ministry of Health (MoH).
Website: http://www.pravo.by/
Website - hospitals: https://www.rceth.by/
http://minzdrav.gov.by/upload/dadvfiles/%D0%BF%D1%80%D0%B8%D0%BB%D0%
BE%D0%B6%D0%B5%D0%BD%D0%B8%D1%8F%20%D0%BA%201180.pdf
Website - laboratories: https://www.rceth.by/
National list for specific clinical interventions/emergencies: Specific lists comments (...
Lists available: Yes Annex 1):
—
Website: http://minzdrav.gov.by/en/dlya-spetsialistov/standarty-obsledovaniya-i-lecheniya/
http://minzdrav.gov.by/en/dlya-spetsialistov/instruktsii-i-metodicheskie-rekomendatsii/index.php
e
In BELCMT there are not informing
HTA unit/department includes the assessment of medical devices: Yes decisions specifically for medical devices.
Unit/department: The Republican Scientific and Practical Center for Medical
Technologies, Informatization, Administration and Management of Health (BELC__)
and Center for expertise and tests in healthcare (RCETH).
Website(s): https://www.rceth.by/ru/About/Activity
https://www.rceth.by/ru/Departments/Me
https://www.rceth.by/ru/Documents/Med/9
https://belcmt.by/en/Common
Contact: — Email: rceth@rceth.by

Name of regulatory agency: Ministry of Health: Center of Expertise and Testing —
in Health Care; Department of Medical Equipment, Logistical Support, and
Construction.
Website(s): http://www.rceth.by
Contact: A. Y. Stolyarov Email: —
Name(s) of other regulatory agency eg. for radiation equipment etc.: Department of Nuclear and Radiation Safety of the
32 Ministry of Emergency Situations of the Republic of Belarus.
Other agency’s website: https://gosatomnadzor.mchs.gov.by/en/o-gosatomnadzore/polozhenie-o-gosatomnadzore/
WHO European Region
Belarus
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed State register of medical equipment and
Use: Not specified medical supplies of Belarus.
Website: https://www.rceth.by/Documents/3mz3prN132420141216.pdf

Procurement
Policy or guideline: Yes Website: http://minzdrav.gov.by/en/ministerstvo/
tsentralizovannye-zakupki.php Medical device incorporation
National level procurement: Yes Website: http://minzdrav.gov.by/en/dlya-spetsialistov/
Public procurement of medical devices
meditsinskie-izdeliya/zakupki-meditsinskikh-izdeliy.php and their specifications for each
https://www.rceth.by/ru/Documents/Med procurement procedure can be found in
http://www.belmt.by/ our website.
Donations
Policy or guideline: Yes Website: http://minzdrav.gov.by/upload/dadvfiles/250.pdf
Website: —
Density per
population

Unit/Department: Department for the sale, installation and repair of medical equipment (Belmedtekhnika).
Unit website: http://minzdrav.gov.by/en/dlya-spetsialistov/meditsinskie-izdeliya/index.php
http://www.belmt.by/
Contact name: Mr. V. A. Hodzhaev Contact email: info@belmt.by
Type of inventories available: National inventory for medical equipment Go to website (first link) and find the
document titled “mfindr”.
Website: http://minzdrav.gov.by/ru/sobytiya/cozdanie-kataloga-izdeliy-meditsinskogo-
naznacheniya/
http://www.rceth.by
Use of management software: Yes Software name: —

Contacts
Name: Mr. V. A. Hodzhaev Name: Dr. Viatcheslav Grankov AI
Email: info@belmt.by Email: eurowhoblr@who.int

Belgium

4.23 85
High
11.5%
aged 30-70 yrs from 10.60% >10% (>25%) of
(1.4%)
income (%):i
Human Development
0.93
Years

(0.86): 49.1 (22)
very high
rank:f
High-technology
ICT Development
7.8 (25) exports (% of 12.00%
Index (rank):g

Website: https://www.afmps.be/fr/humain/produits_de_sante/dispositifs_medicaux/generalites/legislation
Language(s): Français et Néerlandais
Ministry of health responsible for health technology policy implementation: Agence Fédérale des Médicaments et des
Produits de Santé pour les dispositifs médicaux et les dispositifs médicaux implantables actifs et l’Institut Scientifique de
Santé Publique -Section de Biologie clinique- pour les dispositifs médicaux de diagnostic in vitro.

Lists available: Yes, but it is only a recommendation Ces listes existent indirectement par le
remboursement de certains dispositifs
Unit: Institut National d’Assurance Maladie Invalidité (INAMI). médicaux et/ou le remboursement de
certains tests cliniques effectués. Les
Website: https://www.riziv.fgov.be/fr/Pages/default.aspx dispositifs médicaux implantables et
Nomenclature systems used for devices and tests: — invasifs à long terme doivent se trouver
Website - laboratories: http://www.ejustice.just.fgov.be/cgi_loi/loi_a.
pl?language=fr&caller=list&cn=2001111446&la=f&fromtab=loi&sql=dt=%27arrete%20
royal%27&tri=dd+as+rank&rech=1&numero=1
Lists available: Yes Ces listes existent indirectement par le
remboursement de certains dispositifs
Website: — médicaux et/ou le remboursement de
certains tests cliniques effectués.
e
The assestment includes pre-market
HTA unit/department includes the assessment of medical devices: Yes clinical evaluation of innovative high-risk
Unit/department: Health Care Knowledge Center (KCE). medical devices.
Website(s): https://kce.fgov.be/en/health-technology-assessment
https://kce.fgov.be/en/towards-a-guided-and-phased-introduction-of-high-risk-medical-
devices-in-belgium
https://www.wiv-isp.be/en
http://www.inami.fgov.be/
Contact: — Email: info@kce.fgov.be

Name of regulatory agency: Agence Fédérale des Médicaments et des Produits de Agence Fédérale de Contrôle Nucléaire en
Santé (AFMPS). ce qui concerne les dispositifs médicaux
repris sous le point 3 de l’annexe XIII de
Website(s): https://www.afmps.be/fr l’Arrêté royal du 18/03/1999, qui veille au
Contact: Ms. Frédérique Meulders Email: frederique.meulders@afmps.be contrôle et à l’application du Règlement
Général de la Protection de la population,
Name(s) of other regulatory agency eg. for radiation equipment etc.: Competent
Authority for in vitro diagnostic medical devices. Scientific Institute of Public Health - Dept. Clinical Biology Anne Van
Nerom - and Agence Fédérale de Contrôle Nucléaire.
34 Other agency’s website: https://afcn.fgov.be/fr
WHO European Region
Belgium
Website: https://kce.fgov.be/en of MD representatives (of both the
https://www.famhp.be/en national MoH and the national agencies)
available, accessible and transparent
Medical device incorporation nomenclature named European Medical
Device Nomenclature (EMDN)
Procurement
Policy or guideline: Yes Website: https://www.afmps.be/fr
https://www.sciensano.be/en Medical device incorporation
National level procurement: No Website: https://www.afmps.be/fr
Dans chaque Arrêté royal d’application
https://www.sciensano.be/en se trouvent des exigences par rapport
Donations à la distribution et/ou la délivrance
des dispositifs médicaux (docs:
Policy or guideline: No Website: — coord_tcm291-26685.pdf and tcm291-
27069.pdf).|Décision de la Commission
Technical specifications 2002/364/EC portant spécifications
Technical specifications to support procurement or donations: Yes techniques communes des dispositifs
médicaux de diagnostique in vitro.
Website: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:131:0017:0030:fr:PDF
Density per
population


Website: —

Contacts
Name: Ms. Frédérique Meulders Name: —
Email: frederique.meulders@afmps.be Email: weu@who.int
Name: Mr. Tom Clarijs Name: —
General comments (...Annex 1): L’Agence fédérale de Contrôle nucléaire (AFCN) est en train de réviser
les inventaires des dispositifs médicaux émettant des rayonnements ionisants présents en Belgique. Cet inventiare
provient en partie de données fournies par les Organismes Agréés (AV Controlatom, TechniTest, ….). COCIR (European
Coordination Committee of the Radiological, Electromedical and Medical IT Industries) peut également fournir des
Belize

11.66 67
Upper-Middle
aged 30-70 yrs from 16.50% >10% (>25%) of — (—)
income (%):i
Human Development
0.72
Years

(0.55): — (—)
high
rank:f
High-technology
ICT Development
3.7 (120) exports (% of 0.10%
Index (rank):g

Website: —
Language(s): English
Ministry of health responsible for health technology policy implementation: Regulatory Unit.

Unit: —
Website: —
Lists available: Yes Policy Analysis & Planning Unit, Ministry of
Health.
Lists available: No There is no information about which lists
are available.
Website: —
e
HTA unit/department includes the assessment of medical devices: No there is not a specific national unit.
Website(s): —

Website(s): —
36
Belize
Website: —

Procurement
Donations The NEMC is trying to standardize
Policy or guideline: No Website: — equipment, and has suggested to set up
a procurement committee. There is no
Technical specifications follow up.
Website: —
Density per
population
Mammograph:α,* 4 258
Radiotherapy:β 0 0

Type of inventories available: National inventory for medical equipment The NEMC is in the process of updating
the Inventory, only for the public health
Website: — facilities. The Karl Heusner Memorial
Use of management software: No Software name: — Hospital (KHMH) has its own Inventory
System.

Contacts
Name: Mr. Tony Nijssen Name: Dr. Jack Noreen
Email: mohnemc@gmail.com Email: jackn@paho.org
Name: — Name: Dr. Edwin Bolastig
Email: — Email: bolastie@paho.org
Benin

85.94 38
Lower-Middle
10.9%
aged 30-70 yrs from 22.60% >10% (>25%) of
(5.4%)
income (%):i
Human Development
0.55
Years

(0.34): 18.1 (126)
low
rank:f
High-technology
ICT Development
1.9 (161) exports (% of 1.20%
Index (rank):g

Website: —
Language(s): —

Unit: Agence Béninoise de Régulation Pharmaceutique (ABRP)
Website: https://www.abrp.bj/
Website - hospitals: https://www.abrp.bj/dispositif.php
Website - laboratories: https://www.abrp.bj/reactifs.php
https://www.abrp.bj/documents/Liste_DME_30_mars_2020.pdf
Website: —
e
Ilya la Direction de la programmation
HTA unit/department includes the assessment of medical devices: Yes et de la prospective (DPP) et Direction
Unit/department: Direction de la programmation et de la prospective (DPP) des hôpitaux (fait HTA), mais n’est pas
specifiquement pour des dispositifs
Website(s): https://sante.gouv.bj/ médicaux.

Name of regulatory agency: Agence Béninoise de Régulation Pharmaceutique —
(ABRP)
Website(s): https://www.abrp.bj/
Contact: Mr. Isaac Houinsou Hans Email: ihhans@yahoo.fr
Name(s) of other regulatory agency eg. for radiation equipment etc.: International
Atomic Energy Agency (IAEA).
Other agency’s website: https://www.iaea.org/newscenter/news/iaea-advises-benin-on-strengthening-regulatory-infrastructure
38
WHO African Region
Benin
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified La nomenclature CNEH: Centre National
d’Expertise Hospitalière Nomenclature
Website: http://www.sante.gouv.bj/ (from France) est utilisée de façon
informelle dans certains de nos hôpitaux.

Procurement
Donations —
Website: https://www.abrp.bj/
Density per
population
Radiotherapy:β 0 0

Unit present: Yes Professionally trained biomedical/clinical engineers: —
Unit/Department: Agence des Infrastructure Sanitaire de l’Equipement et de la Maintenance (AISEM) Unit website: —
Contact name: Mr. Laurent Houndeton Contact email: houndetonlaurent@hotmail.com
Type of inventories available: National inventory only for high cost technologies —
(such as MRI, CT or PET scanners)
Website: —
Use of management software: Yes Software name: Le fichier excel est utilisé
dans certains cas. En outre, le logiciel G-MAINT, développé au Bénin, est en cours
d’expérimentation dans certains hôpitaux.

Contacts
Name: — Name: Dr. Mamoudou Harouna Djingarey
Email: — Email: djingareyh@who.int
Name: Mr. Laurent Houndeton Name: —
Email: houndetonlaurent@hotmail.com Email: —
Bhutan

27.62 62
Lower-Middle
1.8%
aged 30-70 yrs from 18.50% >10% (>25%) of
(0.4%)
income (%):i
Human Development
0.65
Years

(0.48): — (—)
medium
rank:f
High-technology
ICT Development
3.7 (121) exports (% of —
Index (rank):g

Health technology (medical device) national policy: No, only National Medicine Policy
Website: —
Language(s): —

Lists available: Yes We have a list for each level of health
centre used for annual identification for
Unit: Essentials Medicines and Technology Division. non drug items which includes equipments
but we have not uploaded it in a website.
Website: http://www.moh.gov.bt/
Nomenclature systems used for devices and tests: Adapted nomenclature to GMDN.
Website - hospitals: http://www.moh.gov.bt/
Lists available: No At present we do not have national lists of
recommended medical devices but we are
Website: http://www.moh.gov.bt/ developing a standard list of Equipment
and non-drug items for each level of health
facilities in Bhutan (national, regional,
e
National health technology assessment unit district hospital, Basic health unit I and
HTA is focused on pharmaceutics and
HTA unit/department includes the assessment of medical devices: Yes vaccines but not in medical devices.
Unit/department: Essentials Medicines & Technology Division.
Website(s): https://www.idsihealth.org/our-impact/bhutan/
http://www.moh.gov.bt/
Contact: Ugyen Tashi Email: utashi@health.gov.bt

Name of regulatory agency: Drug Regulatory Authority (DRA). The Medical Devices regulation is currently
Website(s): http://www.dra.gov.bt/ being drafted
Contact: Wangdi Gyeltshen Email: wgyeltshen@dra.gov.bt
40
Bhutan
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: Adapted nomenclature from GMDN
Not specified
Website: —

Procurement
Policy or guideline: Yes Website: http://www.mof.gov.bt/
National level procurement: Yes Website: http://www.moh.gov.bt/
Donations The procurement of MD is conducted by
Policy or guideline: Yes Website: — the Medical Supplies Procurement Division.
Website: —
Density per
population
Mammograph:α,* 0 0
Radiotherapy:β 0 0

Unit/Department: Biomedical Engineer Division Unit website: —
Contact name: Tashi Penjor Contact email: tpenjor@health.gov.bt
Type of inventories available: National inventory for medical equipment The Biomedical Engineering Division under
the Department of Medical Services has
Website: — maintained an Inventory of equipment
Use of management software: No Software name: — above 25,000 rupees only.

Contacts
Name: Dr. Karma Lhazeen Name: Dr. Rui Paulo de Jesus
Email: klhazeen@health.gov.bt Email: jesusr@who.int
Name: Ms. Soira Sonam Tamang Name: —
General comments (...Annex 1): Concerning the Infrastructure section: there is 1 National Referral Hospital with
350 beds, 2 Regional referral hospitals with 150 beds each, 10 district hospitals with 60 to 40 beds. 12 district hospitals
with 20 beds. Out of 192 health posts, 18 are Basic Health Unit grade I with 10 beds, and the remaining 174 health centres
with 2 to 5 beds are Basic Health Unit grade II.
Bolivia (Plurinational State of)

25.37 67
Lower-Middle
6.0%
aged 30-70 yrs from 17.90% >10% (>25%) of
(1.1%)
income (%):i
Human Development
0.72
Years

(0.55): 22.4 (105)
high
rank:f
High-technology
ICT Development
4.3 (112) exports (% of 5.10%
Index (rank):g

Website: http://www.who.int/medical_devices/survey_resources/health_technology_national_policy_bolivia.pdf
Ministry of health responsible for health technology policy implementation: Unidad de Medicamentos y Tecnología en
Salud, Unidad de Servicios de Salud.

Lists available: Yes There is a national medical devices
list (LINADIME) and it is not based in
Unit: Agencia Estatal de Medicamentos y Tecnologías en salud any of the internationally recognized
nomenclature.
Website: https://www.agemed.gob.bo/archivo_uso_racional/linadime/R.A.LINADIME.pdf
Nomenclature systems used for devices and tests: Yes
Lists available: Yes Norma de caracterización de
establecimientos de salud de primer nivel,
Website - hospitals: https://www.minsalud.gob.bo/ La Paz, Bolivia, 2008.
Website - laboratories: https://www.minsalud.gob.bo/images/Descarga/LINAME/
proveedores/DBS-SELECCION-DE-PROVEEDORES-ULTIMO.pdf
Lists available: Yes Ver el Manual para la aplicacion de las
prestaciones de seguros públicos de salud,
Website: https://www.minsalud.gob.bo/ La Paz, Bolivia.
e
—
HTA unit/department includes the assessment of medical devices: Yes
Unit/department: Unidad de Medicamentos y Tecnología en Salud.
Website(s): https://www.agemed.gob.bo/
https://www.agemed.gob.bo/#tecnolovigilancia/contenido
http://redetsa.org/wp/?page_id=322

Name of regulatory agency: Agencia Estatal de Medicamentos y Tecnologías en Unidad de Seguros Públicos de Salud -
Salud Dante Ergueta tel. 591-22495053; Unidad
de Servicios de Salud - Javier Luna Orozco
Website(s): https://www.agemed.gob.bo/ tel. 591- 22495053.
Contact: Dra. Jhoana Sidney Venegas Miranda Email: jvenegas@agemed.gob.bo
Name(s) of other regulatory agency eg. for radiation equipment etc.: Unidad de
Seguros Públicos de Salud.
Other agency’s website: https://aben.gob.bo/
42

C3D4 Official nomenclature system for medical devices: Yes Type: Based on UMDNS Use: —
Not specified
Website: https://www.agemed.gob.bo/

Procurement
Donations Se cuenta con la propuesta de la norma
Policy or guideline: Yes Website: https://www.minsalud.gob.bo/ “Pliego de especificaciones técnicas para
la adquisición de dispositivos médicos”
Technical specifications DBC. La adquisicion se realiza a través
Technical specifications to support procurement or donations: Yes de los gobiernos municipales (Ley del
Medicamento 1737, Reglamento a la ley del
Publically available: Yes Medicamento 25235).
Website: https://www.minsalud.gob.bo/
Density per
population

Unit/Department: Unidad de Seguros Públicos. Unit website: —
Contact name: Mr. Dante Ergueta and Ms. Mari Tejerina Contact email: danteergueta@gmail.com
Type of inventories available: National inventory for medical equipment El inventario de equipos y la aplicación del
plan para la adquisición de equipo médico
Website: https://www.minsalud.gob.bo/ solo se realizó para los departamentos de
Use of management software: No Software name: — Oruro, Beni y Pando.

Contacts
Name: — Name: Ms. Alma Fabiola Morales Salinas.
Email: — Email: moraleaf@paho.org
Name: Mr. Dante Ergueta and Ms. Mari Tejerina Name: Dr. Julio Pedroza
Email: danteergueta@gmail.com Email: pedrozajul@paho.org
Bosnia and Herzegovina

5.73 65
Upper-Middle
8.2%
aged 30-70 yrs from 18.70% >10% (>25%) of
(1.4%)
income (%):i
Human Development
0.78
Years

(0.67): 29 (74)
high
rank:f
High-technology
ICT Development
5.4 (83) exports (% of 5.30%
Index (rank):g

Website: https://www.met.gov.ba/bs-Latn-BA/
http://www.almbih.gov.ba/en/_doc/regulative/medicinal_products_and_medical_devices_act.pdf
Language(s): Bosnian, Croatian, Serbian (local), and English
Ministry of health responsible for health technology policy implementation: Health Sector.
National lists of medical devices Approved devices lists comments

National list of approved priority/essential medical devices, (...Annex 1):
(including IVDs), for procurement or reimbursement: There are the lists of medical devices for
Lists available: Yes procurement regarding the each general
hospital as well as clinical centres (situation
Unit: — analysis of health care institutions). At the
primary health care level, there is a list of
Website: http://www.almbih.gov.ba/ medical equipments that is necessary for
Nomenclature systems used for devices and tests: — family medicine.
Lists available: Yes The Rulebook on Normative Standards for
Establishment of Health Institutions.
Website - hospitals: http://www.almbih.gov.ba/
Website - laboratories: http://www.almbih.gov.ba/_doc/m-sredstva/regms.pdf?123
https://ms.almbih.gov.ba/pages/view-registrovanamedicinskasredstva
Specific lists comments (...Annex 1):
There are documents that regulate the
National list for specific clinical interventions/emergencies: necessary knowledge, skills, procedures
Lists available: Yes and equipment (definition of medical
technology) which are used by those
Website: http://www.almbih.gov.ba/ group of diseases. Also, there are Guides
for specific medical conditions, and
there are adequate contingency plans
e
National health technology assessment unit for responding for public health threats
The HTA is acknowledged in decentralized
HTA unit/department includes the assessment of medical devices: No legislation, and present at a national level.
Website(s): https://apps.who.int/iris/bitstream/handle/10665/336228/WHO-EURO-2020-
1303-41053-55733-eng.pdf

Name of regulatory agency: Agency for Medical Products and Medical Devices For the Republika Srpska: Regarding the
(ALMBiH); Institute for standardization of Bosnia and Herzegovina (ISBIH). procurement of various medical devices,
the company that generally provides
Website(s): http://www.almbih.gov.ba/ the medical device must ensure capable
Contact: Mr. Ph. Tanja Savanovi_ Email: — suppliers who can implement a proper
assessment and who can carry out the
Name(s) of other regulatory agency eg. for radiation equipment etc.: Bosnia and
Herzegovina State Regulatory Agency for Radiation Safety and Nuclear Safety.
Other agency’s website: http://www.darns.gov.ba/en/EnglishDARNS/AboutAs
44
WHO European Region

C3D4 Official nomenclature system for medical devices: No Type: More than one system The nomenclature is based on GMDN and
Use: Not specified EDMA codes; the instructions request
manufacturer and representative of
Website: http://www.fmoh.gov.ba/index.php/zakoni-i-strategije/zakoni/zakon-o-lijekovima-i- manufactures to use GMDN or EDMA
medicinskim-sredstvima codes for making generic names. This
country have free access to the GMDN
base, and found a new version of EDMA
Medical device incorporation codes on the internet.
Procurement
Policy or guideline: Yes Website: http://www.almbih.gov.ba/
National level procurement: Yes Website: http://www.almbih.gov.ba/
Donations Responsible authority in both entities.
Policy or guideline: Yes Website: — Ministry of Health of Republika Srpska is
responsible for the procurement of high-
Technical specifications cost technologies while the Health Care
Technical specifications to support procurement or donations: No Institutions can provide procurement of
other medical equipment.
Website: —
Density per
population

Unit/Department: Agency for Medical Products and Medical Devices. Unit website: http://www.almbih.gov.ba/
Contact name: Dr. Tanja Savanovi_ Contact email: t.savanovic@almbih.gov.ba
Website with publically available technical specifications: http://www.almbih.gov.ba/_doc/upustva-vodici/SPISAK_
NEOPHODNE_DOKUMENTACIJE_ZA_UPIS_MED_SRED_U_REG_MS_BiH2018.pdf
http://www.almbih.gov.ba/_doc/upustva-vodici/Uputstvo_za_registraciju_proizvodjacaMS.pdf
Website: —

Contacts
Name: Ms. Sabina Sahman Name: Dr. Erwin Aime Willy D. Cooreman
Email: sabina.sahman@mcp.gov.ba Email: cooremane@who.int
Name: Dr. Tanja Savanovi_ Name: —
Email: t.savanovic@almbih.gov.ba Email: —
Botswana

44.84 54
Upper-Middle
aged 30-70 yrs from 27.00% >10% (>25%) of — (—)
income (%):i
Human Development
Years

25.4 (89)
rank:f
High-technology
ICT Development
4.6 (105) exports (% of 0.40%
Index (rank):g

Website: https://www.who.int/medical_devices/survey_resources/health_technology_national_policy_botswana.pdf
Ministry of health responsible for health technology policy implementation: Biomedical Engineering Services.

Unit: —
Website: —
Lists available: — Documents are in constant revision and
update.
Website: —
e
It is needed to strengthen the research to
HTA unit/department includes the assessment of medical devices: No improve the HTA capacity.
Unit/department: Clinical Services.
Website(s): —

Name of regulatory agency: Botswana Medicines Regulatory Authority (BoMRA). There is a drug regulatory unit. It has a
Website(s): https://www.bomra.co.bw/index.php/news-updates draft for an Act that will regulate medicines
and medical devices.
Contact: — Email: medicaldevices.services@bomra.co.bw
Name(s) of other regulatory agency eg. for radiation equipment etc.: Radiation
Protection Inspectorate.
Other agency’s website: https://gov.bw/public-safety/radiological-safety-inspections
46
WHO African Region
Botswana
For procurement purposes
Website: https://www.bomra.co.bw/index.php/news-updates

Procurement
Policy or guideline: Yes Website: https://ipms.ppadb.co.bw/login
National level procurement: Yes Website: https://ipms.ppadb.co.bw/login
Donations —
Website: —
Density per
population

Unit/Department: Biomedical Engineering Unit website: —
Contact name: Spencer Sibanda Contact email: ssibanda@gov.bw
Type of inventories available: National inventory for medical equipment There is the Medical Equipment Asset
Register which was completed in
Website: — December 2009. The Custom Solution
Use of management software: Yes Software name: Customized Solution. is being implemented; the contract was
signed on May 19th 2010.

Contacts
Name: Dr. Ndwapi Ndwapi Name: Dr. Josephine Namboze
Email: nndwapi@gov.bw Email: nambozej@who.int
Name: Spencer Sibanda Name: —
Email: ssibanda@gov.bw Email: —
General comments (...Annex 1): Concerning the Infrastructure section: there are 800 clinics, healthposts and
mobile clinics.
Brazil

14.7 75
Upper-Middle
aged 30-70 yrs from 15.50% >10% (>25%) of — (—)
income (%):i
Human Development
0.77
Years

(0.57): 31.9 (62)
high
rank:f
High-technology
ICT Development
6.1 (66) exports (% of 13.30%
Index (rank):g

Website: https://www.gov.br/saude/pt-br
Language(s): Portugues
Ministry of health responsible for health technology policy implementation: Secretariat of Science, Technology and
Strategic Inputs.

Lists available: Yes Lists for diseases are Health Attention
Secretariat (SAS) unit competence. Other
Unit: — lists are not available for the moment.
Website: —
Lists available: Yes Competencia de la Health Attention
Secretariat (SAS).
Website: https://www.gov.br/saude/pt-br
e
Units within the Brazilian HTA Network
HTA unit/department includes the assessment of medical devices: Yes (Rebrats) support CONETEC
Unit/department: Departamento de Gestão e Incorporação de Tecnologias em
Saúde.
Website(s): http://conitec.gov.br/
Contact: Dr. Vania Canuto Santos Email: vania.canuto@saude.gov.br

Name of regulatory agency: Brazilian Health Surveillance Agency (ANVISA)/ —
General Office of Medical Devices.
Website(s): http://antigo.anvisa.gov.br/
Contact: Mrs. Maria Fonseca Veloso Email: rel@anvisa@anvisa.gov.br
Name(s) of other regulatory agency eg. for radiation equipment etc.: Comissão
Nacional de Energia Nuclear.
Other agency’s website: https://www.gov.br/cnen/pt-br/comissao-nacional-de-energia-nuclear/#
48
Brazil
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: Anvisa started working to internalize the
For regulatory purposes GMDN. So far, 100 of Anvisa’s technical
names are compatible with GMDN. Anvisa
Website: www.anvisa.gov.br also works in the implementation of the
Unique Device Identification (UDI) in
Brazil. Anvisa is currently preparing a draft
Medical device incorporation proposal in a working group with the
participation of the private sector, which
Procurement was sent to the Public Consultation (2021).
Policy or guideline: Yes Website: http://portalsaude.saude.gov.br/portalsaude/
National level procurement: Yes
Website: http://portal.saude.gov.br/portal/saude/gestor/area.cfm?id_area1504
In the given website search for the
Donations corresponding documents in procurement
field. There are Lists of OPM, Procedures
Policy or guideline: No Website: — and Protocols.
Website: —
Density per
population


Unit/Department: Department of Science and Technology (DECIT). Unit website: http://portal.saude.gov.br
Contact name: Dr. Leonor Santos Pacheco Contact email: leonor.santos@saude.gov.br
Type of inventories available: None Even though there is no standardized
software for the medical equipment
Website: — management in Brazil, some hospitals
Use of management software: Yes Software name: Locally developed. and other health facilities have developed
and implemented their own. Besides that,
the Post Market Surveillance of Medical
Devices Unit of ANVISA, the Brazilian
Regulatory Authority, intends to develop
Number of biomedical/clinical engineers professionals in the country:γ 600 a software to address the main needs
related to medical electrical equipment
management (information related to the
Contacts history of the medical equipment).

Name: Dr. Leonor Maria Pacheco Santos Name: Dr. Socorro Gross Galiano
Email: leonor.santos@saude.gov.br Email: grosssoc@paho.org
Name: — Name: —
Brunei Darussalam

11.51 77
High
aged 30-70 yrs from 18.50% >10% (>25%) of — (—)
income (%):i
Human Development
Years

29.8 (71)
rank:f
High-technology
ICT Development
6.8 (53) exports (% of 8.50%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
It is a established system for setting
HTA unit/department includes the assessment of medical devices: No healthcare priorities, which involves HTA.
Website(s): —
Contact: — Email: bme@moh.gov.bn

Website(s): —
50
Brunei Darussalam
Website: —

Procurement
Donations —
Website: —
Density per
population

Unit/Department: Biomedical Engineering Unit (BME). Unit website: —
Contact name: — Contact email: bme@moh.gov.bn
Website: —

Contacts
Name: Mr. Abidin Bin Haji Othman Name: —
Email: abidin.othman@moh.gov.bn Email: wpmyswr@who.int
Name: — Name: —
Bulgaria

6.15 70
Upper-Middle
12.8%
aged 30-70 yrs from 24.20% >10% (>25%) of
(0.8%)
income (%):i
Human Development
0.82
Years

(0.72): 40 (37)
very high
rank:f
High-technology
ICT Development
6.9 (50) exports (% of 10.90%
Index (rank):g

Website: —
Language(s): —

Unit: National Health Insurance Fund.
Website: —
Website: —
e
It exists a limited number of trained
HTA unit/department includes the assessment of medical devices: No HTA experts. Relevant health economic
Unit/department: — education is available at several universities
in the region, and HTA experts or health
Website(s): https://www.ncpr.bg/en/health-technology-assessment.html economists work as consultants for the
http://ncpha.government.bg government (more info see third link).
https://apps.who.int/iris/bitstream/handle/10665/336228/WHO-EURO-2020-1303-41053-
55733-eng.pdf

Name of regulatory agency: Bulgarian Drug Agency (BDA). —
Website(s): https://www.bda.bg
http://mh.government.bg
https://mi.government.bg/bg
Contact: — Email: medical@bda.bg
Name(s) of other regulatory agency eg. for radiation equipment etc.: Nuclear
Regulatory Agency.
Other agency’s website: http://www.bnra.bg/
52
WHO European Region
Bulgaria
Website: https://www.mh.government.bg/en/ of MD representatives (of both the
https://www.bda.bg/en/information-for-companies/122-medical-devices-announcements- national MoH and the national agencies)
category available, accessible and transparent
Procurement
Policy or guideline: Yes Website: https://www.bda.bg/images/stories/documents/legal_
acts/201910_MEDICAL%20DEVICES%20ACT.pdf Medical device incorporation
https://www.mh.government.bg/bg/ comments (...Annex 1):
Only for the devices which are supplied
National level procurement: Yes Website: http://www.mh.government.bg/ through a centralized procedure
Donations accomplished by the Ministry of Health.
Website: —
Density per
population

Website: —

Contacts
Name: Mr. Todor Darakchiev Name: Dr. Skender Syla.
Email: todor.darakchiev@bda.bg Email: sylas@who.int
Name: — Name: —
Burkina Faso

84.99 43
Low
3.1%
aged 30-70 yrs from 23.90% >10% (>25%) of
(0.4%)
income (%):i
Human Development
0.45
Years

(0.32): 20 (118)
low
rank:f
High-technology
ICT Development
1.9 (162) exports (% of 25.80%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website - hospitals: https://www.sante.gov.bf/accueil
Website - laboratories: http://www.sante.gov.bf/SiteSante/documents/normes-infra.pdf
Website: —
e
—
Website(s): —

Name of regulatory agency: — The RPNS within the NRA is in the process
Website(s): https://anrp.bf/ of institutionalization.
Name(s) of other regulatory agency eg. for radiation equipment etc.: National
Regulatory Authority for Radiation Protection and Nuclear Safety
Other agency’s website: https://www-pub.iaea.org/mtcd/meetings/PDFplus/2009/cn166/CN166_Presentations/Session%20
8/006%20Belemsaga.pdf
54
WHO African Region
Burkina Faso
Website: —

Procurement
Donations Les achats se font selon plusieurs
Policy or guideline: No Website: — procédures en fonction de la source de
financement (les projets font des appels
Technical specifications d’offres de façon indépendante, les
Technical specifications to support procurement or donations: No hôpitaux exécutent en interne une partie
du budget achat, les achats groupés
Publically available: — au niveau national sont en train d’être
expérimentés par la CAMEG: Centrale
Website: — d’Achat des Médicaments Génériques); des
apels d’offres internationaux sont quelque
Density per fois lancés par les projets.
population
Radiotherapy:β 0 0

Unit/Department: Department of medical Products (DMP). Unit website: —
Contact name: Mr. Hamidou Sama Contact email: —
Type of inventories available: National functional inventory for medical equipment Inventaire technique au niveau national
a été fait par la DGIEM en 2003 avec
Website: — l’appui de la GTZ; un inventaire non
Use of management software: Yes Software name: PLAMAHS (Heart Consultancy). technique a été fait par la DAF en 2007
suivant une procédure du Ministère de
l’Economie et des Finances. La mise à
jour de ces inventaires n’est pas effective.
Il y a les deux types d’inventaire: national
Number of biomedical/clinical engineers professionals in the country:γ <10 fonctionnel pour certain équipement
médicale et non-fonctionnel pour d’autres.
Contacts
Name: Mr. O. Emmanuel Zida Name: Dr. Alimata J. Diarra-Nama
Email: ezida2002@yahoo.fr Email: diarraal@who.int
Name: Ms. Micheline Ouédraogo Name: Dr. Daogo Sosthène Zombre
Email: mkonkobo1@yahoo.fr Email: zombres@who.int
General comments (...Annex 1): Concerning the HT national policy, a 2010 version was provided. Concerning the
Section Infrastructure: There are 3 CHU and 1 Hôpital national.
Burundi

54.35 44
Low
3.3%
aged 30-70 yrs from 25.00% >10% (>25%) of
(0.4%)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
1.5 (172) exports (% of 1.50%
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Autorité Burundaise de Régulation des
Médicaments et des Aliments

Lists available: Yes Nous avons des listes préétablies suivant le
type de catégories conformes aux normes
Unit: Direction des Infrastructures Sanitaires et des Equipements (DISE). en vigueur au MoH.
Website: —
Lists available: Yes Nous avons également de la
documentation sur la normalisation des
Website - hospitals: — équipements par structures de soins.
Lists available: Yes Lists available for communicable and
non communicable diseases, injuries, and
Website: — public health emergency situations.
e
—
HTA unit/department includes the assessment of medical devices: —
Unit/department: Département des Infrastructures sanitaires et des équipements
(DISE)
Website(s): —

Name of regulatory agency: Autorité Burundaise de Régulation des Médicaments et —
des Aliments
Website(s): —
Contact: Mr. Emmanuel Bamenyekanye Email: bamenyekanye@hotmail.com
56
WHO African Region
Burundi
Website: —

Procurement
Donations Procédé aux achats/Système d’appel
Policy or guideline: Yes Website: — d’offres ouvert national/international.
Il existe des entreprises nationales
Technical specifications spécialisées dans la vente de ces produits.
Website: —
Density per
population
Radiotherapy:β 0 0

Unit/Department: Direction des Infrastructures Sanitaires et des Equipements (DISE) Unit website: —
Contact name: Mr. Eugène Mujambere Contact email: mujambereeugene@yahoo.fr
Type of inventories available: National functional inventory for medical equipment —
Website: —

Contacts
Name: Mr. Déo Niyonkuru Name: Dr. Xavier Crespin
Email: niyonkurunew@yahoo.fr Email: cxavier@who.int
Name: Mr. Eugène Mujambere Name: Dr. Donatien Bigirimana
Email: mujambereeugene@yahoo.fr Email: bigirimanad@who.int
Cambodia

25.68 61
Lower-Middle
15.3%
aged 30-70 yrs from 22.50% >10% (>25%) of
(5.2%)
income (%):i
Human Development
0.59
Years

(0.48): 21.5 (110)
medium
rank:f
High-technology
ICT Development
3.3 (128) exports (% of 1.20%
Index (rank):g

Website: —
Language(s): Khmer and English
Ministry of health responsible for health technology policy implementation: Hospital Services and Biomedical Engineering
Bureau, Department of Hospital Services, Ministry of Health.

Unit: —
Website: —
Lists available: Yes a) Medical Equipment Standard list
for CPA referral Hospitals; b) Medical
Website - hospitals: — Equipment Standard list for Minimum
Package of activity (MPA) (Health Centre).
Website: —
e
It has been started the development
HTA unit/department includes the assessment of medical devices: No of HTA systems by establishing nodal
Unit/department: Department of Hospital Service. agencies and conducting ad-hoc activities.
Website(s): —

Website(s): —
58
Cambodia
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed The Hospital Service Bureau has
Use: For procurement purposes developed standard medical equipment
nomenclature for public hospitals in
Website: — Cambodia and it has been utilized for
medical equipment management and
maintenance.
Procurement
Donations Procurement: Health Sector Support
Policy or guideline: No Website: — Program (HSSP2) is the implementation
project team under the direction of
Technical specifications Health Sector Strategic Plan (HSP2) of
Technical specifications to support procurement or donations: Yes the Ministry of Health. Medical Equipment
standard list for CPA1,2,3 referral hospitals.
Website: —
Density per
population

Unit/Department: Department of Planning and Health Information. Unit website: —
Type of inventories available: National functional inventory for medical equipment The software was originally developed
by the Ministry of Health (MoH). The
Website: — Department of Hospital service is
Use of management software: Yes Software name: MEDEMIS. managing inventories for medical
equipment of four National hospitals and
18 CPA3 level hospitals. The Controlled
medical equipment requires management
(monitoring), maintenance and repair.
Contacts
Name: Dr. Cheu Sivuthy Name: Dr. Ailan Li
Email: cheusivuthy@gmail.com Email: lia@who.int
Name: — Name: —
Cameroon

72.21 44
Lower-Middle
10.8%
aged 30-70 yrs from 23.90% >10% (>25%) of
(3.0%)
income (%):i
Human Development
0.56
Years

(0.38): 20 (119)
medium
rank:f
High-technology
ICT Development
2.4 (149) exports (% of 6.00%
Index (rank):g

Website: —
Language(s): Français et Anglais
Ministry of health responsible for health technology policy implementation: Direction de l’Organisation des Soins et de la
Technologie Sanitaire.

Unit: —
Website: —
Website: —
e
—
Website(s): —

Name of regulatory agency: — Il existe un organisme chargé de
Website(s): — la réglementation concernant les
équipements qui émettent les
Contact: — Email: — rayonnements ionisants. l’Agence
Nationale de Radioprotection. Contact: Dr.
Name(s) of other regulatory agency eg. for radiation equipment etc.: National SimoAugustin, e-mail: augsimo@yahoo.fr.
Radiationprotection Agency (NRPA).
Other agency’s website: https://gnssn.iaea.org/main/ANNuR/Activity%20Documents%20%20Public/Regional%20
Workshop%20on%20Management%20a%20Safe%20Disposal%20of%20Radioactive%20Waste/CAMEROON.pdf
60
WHO African Region
Cameroon
Website: —

Procurement
Donations Procurement: Il existe des directives
Policy or guideline: No Website: — générales concernant tous les marchés
publics. Les hôpitaux et autres formations
Technical specifications disposent aussi de budgets propores pour
Technical specifications to support procurement or donations: Yes l’achat de dispositifs médicaux.
Website: —
Density per
population

Unit/Department: Studies and Project Division (DEP). Unit website: http://www.minsante.cm/
Type of inventories available: None Les bailleurs de fonds réalisent des
inventaires dans leurs zones d’intervention,
Website: — mais il n’existe pas d’inventaire national.

Contacts
Name: Mr. Vincent Ngaleu Toko Name: Dr. Phanuel Habimana
Email: vngaleutoko@yahoo.fr Email: habimanap@who.int
Name: — Name: Dr. Samuel Besong
Email: — Email: besongs@who.int
General comments (...Annex 1): L’étude devrait inclure la formation dans le domaine. Le Cameroun dispose
d’un cycle de formation de techniciens en maintenance hospitalière qui fonctionne depuis deux ans dans trois lycées
techniques, le diplôme de sortie délivré au bout de trois ans est l’équivalent du bacccalauréat. Il existe également des
cycles de formation dans le domaine en enseignement supérieur.
Canada

4.99 89
High
2.6%
aged 30-70 yrs from 9.60% >10% (>25%) of
(0.5%)
income (%):i
Human Development
0.93
Years

(0.85): 52.3 (17)
very high
rank:f
High-technology
ICT Development
7.8 (29) exports (% of 16.50%
Index (rank):g

Website: www.cadth.ca
Language(s): English and Français
Ministry of health responsible for health technology policy implementation: Canadian Agency for Drugs and Technologies
in Health (CADTH).

Lists available: No Given the nature of the Canadian
Constitution, these are of provincial
Unit: — jurisdiction and not at the federal or
national jurisdictional level.
Website: —
Lists available: No Given the nature of the Canadian
Website: — jurisdiction and not at the federal or
national jurisdictional level.
e
There are several HTA agencies, mainly
HTA unit/department includes the assessment of medical devices: Yes regional.
Unit/department: Canadian Agency for Drugs and Technologies in Health (CADTH).
Website(s): https://www.cadth.ca/
Contact: Dr. Lesley Dunfield Email: lesleyd@cadth.ca

Name of regulatory agency: Health Canada, Health Products and Food Branch, In addition, for radiation emitting medical
Medical Devices Directorate devices, there is Health Canada, Healthy
Environments and Consumer Safety
Website(s): http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php Branch, Consumer and Clinical Radiation
Contact: David Boudreau Email: mddpolicy-politiquesdim@hc-sc.gc.ca Protection Bureau (http://www.hc-sc.
gc.ca/ahc-asc/branch-dirgen/hecs-
Name(s) of other regulatory agency eg. for radiation equipment etc.: Consumer and
Clinical Radiation Protection Bureau
Other agency’s website: https://www.canada.ca/en/health-canada/corporate/mandate/regulatory-role/what-health-canada-
regulates-1/radiation.html
62
Canada
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: Canada uses both: Preferred Name Codes
For regulatory purposes (based on US FDA Panel Codes) and
GMDN. Not publicly available.
Website: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
devices/activities/announcements/notice-global-medical-device-nomenclature.html

Procurement
Donations Given the nature of the Canadian
Policy or guideline: No Website: — Constitution, these are of provincial
jurisdiction and not at the federal or
Technical specifications national jurisdictional level.
Website: —
Density per
population


Type of inventories available: CADTH maintains a Canadian Medical Imaging Given the nature of the Canadian
Inventory for medical imaging equipment. jurisdiction and not at the federal or
Website: — national jurisdictional level. While there
are no national inventories, the Canadian
Use of management software: — Software name: — Institute for Health Information produces
regular reports on selected imaging
technologies in Canada. The most recent
Medical devices workforce report is available at: https://www.cihi.
ca/en .
Contacts
Name: Mr. David Boudreau Name: Ms. Mary Lou Valdez
Email: mddpolicy-politiquesdim@hc-sc.gc.ca. Email: valdezmar@paho.org
Name: Dr. Lesley Dunfield Name: —
Email: lesleyd@cadth.ca Email: —
General comments (...Annex 1): In several survey’s sections (e.g. section health policy), we were not able to
reflect the shared governance approach that Canada has evolved towards as several as the key organisations, namely, the
Canadian Agency for Drugs and Technologies in Health are neither national nor provincial but entities whose governance
and financing is shared among the Deputy Minister of Health of Canada’s 14 jurisdictions (e.g. Federal, 10 provinces and 3
Cabo Verde

14.19 69
Lower-Middle
aged 30-70 yrs from 17.40% >10% (>25%) of — (—)
income (%):i
Human Development
Years

23.9 (100)
rank:f
High-technology
ICT Development
4.9 (93) exports (% of 0.00%
Index (rank):g

Website: http://www.minsaude.gov.cv
Language(s): Portuguese
Ministry of health responsible for health technology policy implementation: General Directorate of Planning, Budgeting
and Management

Lists available: No Standards: CARTA SANITÁRIA DE CABO
VERDE (1999).
Unit: —
Website: —
Lists available: Yes Standards: CARTA SANITÁRIA DE CABO
VERDE (1999).
Website - hospitals: https://www.who.int/medical_devices/survey_resources/medical_
devices_by_facility_cape_verde.pdf
Lists available: No No, it is done according to the needs and
the procedures of our action plan for the
Website: — next years.
e
HTA is focused on pharmaceutics but not
HTA unit/department includes the assessment of medical devices: No in medical devices.
Website(s): —

Name of regulatory agency: Health Regulatory Independent Entity (ERIS) There is a department in charge of medical
Website(s): http://www.eris.cv devices, but there is no legislation nor
registration of medical devices yet.
Contact: Ms. Edith Santos Email: edith.santos@gov.cv
64
WHO African Region
Cabo Verde
Website: —

Procurement
National level procurement: Yes Website: http://www.minsaude.gov.cv
Donations —
Website: —
Density per
population
Radiotherapy:β 0 0

Unit/Department: Health Infrastructure and Equipment Maintenance and Management Service Unit website: —
Contact name: Ms. Margarida Cardoso Contact email: margarida.cardoso@gocv.gov.cv
Type of inventories available: None There is no national inventory of medical
equipment. There’s a plan to do it soon.
Website: —

Contacts
Name: — Name: Dr. Daniel A. Kertesz
Email: — Email: kerteszd@who.int
Name: Ms. Margarida Cardoso Name: —
Email: margarida.cardoso@gocv.gov.cv Email: —
General comments (...Annex 1): In conclusion, there is a need to organize the park of medical devices. We
would like to make a national inventory for medical equipment, assess the needs, and organizing technical guidelines
for procurement to elaborate a clear plan of medical devices management. We think it is time to develop legislation for
medical devices.
Central African Republic

103 32
Low
aged 30-70 yrs from 36.00% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
1 (175) exports (% of 29.00%
Index (rank):g

Website: —
Language(s): —

Lists available: Yes En concernant acquisition il ya une longue
durée entre la commande et la réception.
Unit: Unité de cession des médicaments et équipements médicaux.
Website: —
Lists available: Yes Arrêté du ministre de la santé publique et
de la population. Profil des participants:
Website: — Médecin, chirurgiens, techniciens de santé,
techniciens bio médicaux. Date de révision:
Mars 2010.
e
—
Website(s): —

Name of regulatory agency: Direction des Infrastructures Sanitaires. No.
Website(s): —
Contact: Mrs. Claudine Kaya Email: nzoulouc@yahoo.fr
66
WHO African Region
Central African Republic

Website: —

Procurement
Donations Achat groupé par les parténaires,
Policy or guideline: No Website: — passation de marché. Longue durée entre
la commande et la réception.
Website: —
Density per
population
Computerized Tomography Scanner:α 0 0
Radiotherapy:β 0 0

Type of inventories available: National functional inventory for medical equipment Réalisée par la direction des infrastructures
sanitaires. Il y a les deux types d’inventaire:
Website: — national fonctionnel pour certain
Use of management software: No Software name: — équipement médicale et non- fonctionnel
pour d’autres.

Contacts
Name: — Name: Dr. Ngoy Nsenga
Email: — Email: nsengan@who.int
Name: Mr. Leppa Name: Dr. Florentine Sylvie Mberyo Yaah
Email: — Email: mberyos@who.int
General comments (...Annex 1): Concerning the HT national policy it is stated in the following document
POLITINACIONALSAUDE_VERSÃOVALIDADA 2020.
Chad

110.05 28
Low
aged 30-70 yrs from 22.70% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
1.3 (174) exports (% of —
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Direction Générale Technique Pharmacie,
Médicament et Laboratoire (DGTPML)

Lists available: Yes It is needed to revise the list
Unit: Direction Générale Technique Pharmacie, Médicament et Laboratoire
(DGTPML)
Website: —
Website: —
e
—
Unit/department: Direction des infrastructures, équipements et maintenance
(DIESM)
Website(s): —

Name of regulatory agency: Direction Générale Technique Pharmacie, Médicament —
et Laboratoire (DGTPML)
Website(s): —
Name(s) of other regulatory agency eg. for radiation equipment etc.: The Chadian
Agency of Radiation Protection and Nuclear Security (ATRSN).
Other agency’s website: https://www.iaea.org/sites/default/files/17/11/cn-254-alifei-presentation.pdf
68
WHO African Region
Chad
Website: —

Procurement
Donations There is a need to update the guideline.
Website: —
Density per
population


Unit/Department: Centrale Pharmaceutique d’Achats (CPA)- Division Approvisionnement and Division Assurance Qualité,
Direction des infrastructures, équipements et maintenance Unit website: —
Type of inventories available: Periodic —
Website: —
Use of management software: Yes Software name: G-Stock/MSPSN (2014-2015)

Contacts
Name: Mr. Ngardibaye Madjimbaye Name: Dr. Jean-Bosco Ndihokubwayo
Email: madjimbayen@yahoo.fr Email: ndihokubwayoj@who.int
Name: Mr. Djémian Mongbe Name: —
General comments (...Annex 1): The lack of a national policy in matters of health technology does not allow
access to information on medical devices that could support the action plan with regards to training of users, specialists
and maintenance technicians.
Chile

6.75 80
High
14.6%
aged 30-70 yrs from 10.00% >10% (>25%) of
(2.1%)
income (%):i
Human Development
0.85
Years

(0.71): 33.9 (54)
very high
rank:f
High-technology
ICT Development
6.6 (56) exports (% of 7.50%
Index (rank):g

Website: —
Language(s): —

Lists available: Yes, but it is only a recommendation Existen 8 listas de los dispositivos médicos
que están bajo control obligatorio en el
Unit: Departamento Agencia Nacional de Dispositivos Médicos, Innovación y país: Guantes de examinación, Guantes
Desarrollo, ANDID - ISP quirúrgicos, Preservativos masculinos y
femeninos de látex y sintéticos, Agujas
Website: https://www.ispch.cl/andid/ hipodérmicas, Jeringas hipodérmicas
https://www.ispch.cl/andid/listado-de-dispositivos-medicos-establecimientos-y-empresas/
Nomenclature systems used for devices and tests: Yes
Lists available: No No se dispone de las listas de tecnologías
sanitarias de este apartado.
Website: —
e
—
Unit/department: Institute of Public Health and MoH.
Website(s): https://www.ispch.cl/
http://redetsa.org/wp/?page_id=322; https://etesa-sbe.minsal.cl/
Contact: Dino Seplveda Email: dino.sepulveda@minsal.cl

Name of regulatory agency: Departamento Agencia Nacional de Dispositivos —
Médicos, Innovación y Desarrollo, ANDID - ISP
Website(s): https://www.ispch.cl/andid/
Contact: Ms. Janepsy Díaz Email: jdiaz@ispch.cl
Name(s) of other regulatory agency eg. for radiation equipment etc.: Comisión
Chilena de Energía Nuclear.
Other agency’s website: https://www.cchen.cl/
70
Chile
Website: —

Procurement
Policy or guideline: Yes Website: https://www.ispch.cl/sites/default/files/normativa_
andid/Decreto%20Exento%2093.pdf Medical device incorporation
National level procurement: Yes Website: http://www.minsal.cl
http://www.minsal.cl
Donations
Website: —
Density per
population

Website: —

Contacts
Name: Mr. Luis Vera Benavides Name: Dr. Luis Fernando Leanes
Email: lvera@minsal.cl Email: leanesf@paho.org
Name: Mr. Luis Ampuero Velásquez Name: —
Email: lampuero@minsal.cl Email: —
General comments (...Annex 1): Concerning the Infrastructure section: Los 21 centros de salud están incorporados
en los 100 hospitales distritales/rurales. Los Centros de Referencia de Salud (CRS) = 7 considera a los Hospitales de Chile
denominados de Mediana Complejidad y que se ubican en la región metropolitana y demás regiones del país. Tambien
existen también los hospitales de Chile denominados de Alta Complejidad. Se ubican en la región metropolitana y demás
regiones del país. Estos hospitales tienen la calidad de “Establecimientos Auto-gestionados en red”, incluyendo los base
de regiones y los Institutos de especialidades, que se concentran en la Región Metropolitana. En lo que concierne a
China

Population 000s (rank):a 1,439,324 (1) Under-five mortality UHC - Service coverage
7.34 82
Upper-Middle
19.7%
aged 30-70 yrs from 15.90% >10% (>25%) of
(5.4%)
income (%):i
Human Development
0.76
Years

(0.64): 53.3 (14)
high
rank:f
High-technology
ICT Development
5.6 (80) exports (% of 30.80%
Index (rank):g

Website: http://en.nhc.gov.cn/
https://www.nmpa.gov.cn/
Language(s): —
Ministry of health responsible for health technology policy implementation: Department of Planning and Finance, State
Food and Drug Administration.

Unit: —
Website: —
Website: —
e
—
Unit/department: Department of planning and finance MoH; China National Health
Development Research Center (CNHDRC); Fudan University (Key Lab of Health
Technology Assessment: KLHTA).
Website(s): http://www.futurehealthsystems.org/cnhdrc
https://chta.fudan.edu.cn/WHOCC-CHN86_HTA%20policy%20brief_2018_Issue%201.pdf

Name of regulatory agency: Ministry of Health, State Food and Drug Administration. —
Website(s): http://en.nhc.gov.cn/
Contact: Ms. Yasha Huang Email: huangys@cfda.gov.cn
Name(s) of other regulatory agency eg. for radiation equipment etc.: China Atomic
Energy Authority; National Health Commission of the People’s Republic of China.
Other agency’s website: http://www.caea.gov.cn/
http://en.nhc.gov.cn/
72
China
Not specified
Website: https://www.nmpa.gov.cn/
http://english.nmpa.gov.cn/2019-12/14/c_432228.htm

Procurement
National level procurement: Yes Website: http://en.nhc.gov.cn/
—
Donations
Policy or guideline: Yes Website: http://en.nhc.gov.cn/
Website: http://en.nhc.gov.cn/
Density per
population


Unit/Department: Department of Technology and Education. Unit website: —
Website: —

Contacts
Name: — Name: Dr. Gauden Galea
Email: — Email: galeag@who.int
Name: — Name: Ms. Jianrong Qiao
Email: — Email: qiaoj@who.int

Colombia

13.19 78
Upper-Middle
8.2%
aged 30-70 yrs from 9.70% >10% (>25%) of
(2.2%)
income (%):i
Human Development
Years

30.8 (68)
rank:f
High-technology
ICT Development
5.4 (84) exports (% of 9.10%
Index (rank):g

Website: https://www.who.int/medical_devices/survey_resources/health_technology_national_policy_colombia.pdf
Ministry of health responsible for health technology policy implementation: Dirección de Medicamentos y Tecnologías en
Salud.

Lists available: Yes No existe un listado oficial. El acuerdo
No.008 de La Comisión de Regulación
Unit: Dirección de Medicamentos y Tecnologías en Salud. en Salud (CRES) establece que los
dispositivos médicos usados en los
Website: https://www.minsalud.gov.co/salud/MT/Paginas/dispositivos-medicos-equipos- procedimientos listados son reembolsados
biomedicos.aspx dentro del Plan de Beneficios en Salud.
Website - laboratories: https://web.sispro.gov.co/WebPublico/Consultas/
ConsultarDetalleReferenciaBasica.aspx?Code=DispositivosMedicos
Website: —
e
The INVIMA (Instituto Nacional de
HTA unit/department includes the assessment of medical devices: Yes Vigilancia en Medicamentos y alimentos)
Unit/department: IETS centralizes HTA and the IETS (Instituto de Evaluación
Tecnológica en Salud) perform HTA.
Website(s): https://www.iets.org.co/
Contact: Adriana Robayo Email: adriana.robayo@iets.org.co

Name of regulatory agency: Instituto Nacional de Vigilancia de Medicamentos y El INVIMA tiene dos dependencias
Alimentos (INVIMA). relacionadas, la Subdirección de Registros
Sanitarios que tiene un grupo funcional
Website(s): https://www.invima.gov.co/en/dispositivos-medicos-y-equipos-biomedicos específico de dispositivos médicos y se
Contact: Ms. Lucía Ayala Rodríguez Email: layalar@invima.gov.co encarga de la evaluación y autorización
pre-mercado de los dispositivos médicos;
Name(s) of other regulatory agency eg. for radiation equipment etc.: Instituto
Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA); Ministerio de Minas y Energía.
Other agency’s website: https://www.invima.gov.co/en/dispositivos-medicos-y-equipos-biomedicos
https://www.minenergia.gov.co
74
Colombia
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed Nationally developed. It is in the phase of
Use: For regulatory and procurement purposes implementation.
Website: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/DE/DIJ/
resolucion-2535-de-2013.pdf
https://www.invima.gov.co/

Procurement
Donations —
Policy or guideline: Yes Website: https://www.invima.gov.co/en/
Website: https://www.minsalud.gov.co/Normatividad_Nuevo/Forms/DispForm.
aspx?ID=5524
Density per
population


Unit/Department: Dirección de Medicamentos y Tecnologías en Salud.
Unit website: https://www.minsalud.gov.co/Paginas/default.aspx
Contact name: Ms. Marleny Montenegro Guerrero Contact email: mmontenegro@minsalud.gov.co
Website with publically available technical specifications: https://www.invima.gov.co/web/guest/dispositivos-medicos-y-equipos-
biomedicos#8022021034110455-etabs-ecollapse-1-2
https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/DE/DIJ/Resoluci%C3%B3n_4002_de_2007.pdf
https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/MET/proyecto-resolucion-ortesis-protesis.pdf
https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/MET/observaciones-respuestas-proyecto-resolucion-
dispositivos-ayuda-auditiva.pdf
Type of inventories available: None Actualmente no hay inventario nacional, se
ha intentado elaborar mediante el catastro
Website: — de equipamiento físico. En la normatividad
Use of management software: No Software name: — vigente, el Decreto 4725 de 2005,
establece que los equipos biomédicos
de tecnología controlada deben contar
Medical devices workforce con registro sanitario o con permiso de
comercialización en Colombia.
Contacts WHO Country officer(s):

National officer(s):
Name: Dr. Gina Tambini
Name: Ms. Marleny Montenegro Guerrero
Email: mmontenegro@minsalud.gov.co Email: tambinig@paho.org
Name: — Name: Dra. Monica Padilla

Email: — Email: padillamo@paho.org
General comments (...Annex 1): Actualmente se tiene reglamentado y en fase de implementación el Programa
Nacional de Tecnovigilancia Post-mercado liderado por el Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Comoros

61.34 44
Lower-Middle
8.8%
aged 30-70 yrs from 20.60% >10% (>25%) of
(1.6%)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
1.8 (164) exports (% of 3.00%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Name of regulatory agency: Direction des Etablissements de soins Publics et Privés. Inspection Général de la Santé.
Website(s): —
Contact: Dr. Ahamada Said Fazul Email: —
76
WHO African Region
Comoros
Website: —

Procurement
Donations La Evaluación de Tecnologías se
Policy or guideline: No Website: — reglamentó en el año 2011 mediante la Ley
1438, la cual será competencia del Instituto
Technical specifications Nacional de Evaluación de Tecnologías que
Technical specifications to support procurement or donations: No está en proceso de creación.
Website: —
Density per
population
Radiotherapy:β 0 0

Website: —

Contacts
Name: Dr. Ahamada Said Fazul Name: Dr. Abdoulaye Diarra
Email: sfazul@yahoo.fr Email: diarraa@who.int
Name: Dr. Ahamada Said Fazul, Ministère de la santé Name: —
Congo

44.63 40
Lower-Middle
4.6%
aged 30-70 yrs from 22.60% >10% (>25%) of
(0.7%)
income (%):i
Human Development
0.57
Years

(0.43): — (—)
medium
rank:f
High-technology
ICT Development
— (—) exports (% of 6.70%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Name of regulatory agency: Direction des laboratoires. —
Website(s): —
Contact: Mr. Arthur Ngole Email: arthurngolet@gmail.com
78
WHO African Region
Congo
C3D4 Official nomenclature system for medical devices: No Type: More than one system La Nomenclature officiel n’existe pas. Mais
Use: Not specified sinon, on utilise ce qui peut etre à la portée
de la main et selon les circonstances.
Website: —

Procurement
Donations L’achat des dispositifs médicaux est
Policy or guideline: Yes Website: — décentralisé. il peut se faire au niveau
national comme à l’étranger.
Website: —
Density per
population


Unit/Department: Direction des laboratoires. Unit website: —
Contact name: Mr. Arthur Ngolet Contact email: arthurngolet@gmail.com
Website: —

Contacts
Name: Mr. Arthur Ngolet Name: Dr. Lucien Alexis Manga
Email: arthurngolet@gmail.com Email: mangal@who.int
Name: — Name: Dr. Ray Mankele
Email: — Email: mankeler@cg.afro.who.int
Cook Islands

7.39 54
—
aged 30-70 yrs from — >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—): — (—)
rank:f
High-technology
ICT Development
— (—) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
Website(s): —

Website(s): —
80
Cook Islands
Website: —

Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: — Name: Dr. Mark Andrew Jacobs
Email: — Email: jacobsma@who.int
Name: — Name: —
Costa Rica

7.91 78
Upper-Middle
9.8%
aged 30-70 yrs from 9.50% >10% (>25%) of
(1.7%)
income (%):i
Human Development
0.81
Years

(0.66): 33.5 (56)
very high
rank:f
High-technology
ICT Development
6.4 (60) exports (% of 17.60%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website - hospitals: http://www.ccss.sa.cr
Website - laboratories: https://www.ministeriodesalud.go.cr/index.php/informacion/
productos-registrados
https://www.ministeriodesalud.go.cr/index.php/informacion/productos-registrados/2754-
emb/file
Lists available: Yes Existen protocolos y procedimientos
para las enfermedades y situaciones de
Website: http://www.ccss.sa.cr emergencias en mención, pero no existen
listas de dispositivos médicos como tales.
e
Two entities perform HTA: Caja
HTA unit/department includes the assessment of medical devices: Yes Costarricense de Seguro Social (CCSS)
Unit/department: Dirección de Desarrollo Científico y Tecnológico en Salud and DDCTS. The extension of the HTA
entities is at subnational level, not at
(DDCTS) MoH and Caja Costarricense de Seguro Social (CCSS). national level.
Website(s): https://www.ccss.sa.cr/
http://www.ministeriodesalud.go.cr
Contact: Gabriela Murillo Jenkins Email: gmurilloj@ccss.sa.cr

Name of regulatory agency: Ministerio de Salud. El Ministerio de Salud tiene a su cargo el
Website(s): http://www.ministeriodesalud.go.cr/index.php/ registro y control del equipo y material
biomédico mediante el Reglamento Nº
Contact: Ms. Giselle Rodriguez Email: grodriguez@ministeriodesalud.go.cr 34482-S para el uso, registro, clasificación,
importación y control de equipo y material
Name(s) of other regulatory agency eg. for radiation equipment etc.: — biomédico. El Sistema Integrado de
Other agency’s website: https://www.sicop.go.cr/index.jsp Compras Públicas sigue la regulacion
vigente para hacer sus respectivas
compras de productos de salud.
82
Costa Rica
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed The GMDN has been adapted to the
Use: For regulatory and procurement purposes national needs.
Website: https://www.ministeriodesalud.go.cr/index.php/acceso-a-sistemas-de-informacion

Procurement
National level procurement: Yes Website: https://www.ccss.sa.cr/
Donations La Caja Costarricense de Seguro Social
Policy or guideline: Yes Website: https://www.ministeriodesalud.go.cr/index.php/ brinda cobertura universal a la población
y es el mayor proveedor de servicios de
registro-de-productos-de-interes-sanitario?id=637 salud del país, tanto en hospitales, clínicas
Technical specifications y áreas de salud, por lo que se considera
que hace la adquisición a nivel nacional.
Technical specifications to support procurement or donations: Yes También hay adquisiciones en el sector
Publically available: Yes privado de dispositivos médicos en menor
escala; de esta última no se tiene acceso al
Website: https://www.ministeriodesalud.go.cr/index.php/registro-de-productos-de- inventario.
interes-sanitario?id=637
Density per
population

Unit/Department: Unidad de Gestión de Tecnologías en Salud/Dirección de Desarrollo Científico y Tecnológico en Salud.
Unit website: —
Contact name: Ms. Ana Eduviges Sancho Jiménez Contact email: esancho@ministeriodesalud.go.cr
Type of inventories available: National inventory for medical equipment El Ministerio de Salud cuenta con la base
de datos de los productos de equipo y
Website: http://www.ccss.sa.cr material biomédico registrados para el
Use of management software: Yes Software name: Visual Basic 6.0, Base de datos país. Para cualquier adquisición dentro del
país es necesario contar con su registro,
SQL Server 2005 and Access. pero no es del tipo inventario pues no se
contabiliza; el registro tiene cinco años
de vigencia. En el caso de la CCSS (ver
Medical devices workforce https://www.ccss.sa.cr/ ) se tiene un
inventario por establecimiento (en los
Number of biomedical/clinical engineers professionals in the country:γ 85 tres niveles de atención) tanto a nivel
hospitalario como en clínicas y áreas de
salud. Del sector privado se ha reportado
Contacts que cuentan con inventarios de equipos
por institución, sin embargo no se tiene
Name: — Name: Dr. María Dolores Perez-Rosales
Email: — Email: perezmd@paho.org
Name: Ms. Ana Eduviges Sancho Jiménez Name: Dr. Gustavo Mery
Email: esancho@ministeriodesalud.go.cr Email: merygus@paho.org
General comments (...Annex 1): Es díficil que las

instituciones den cierta información que consideran es confidencial, por el ejemplo: el acceso a sus inventarios de equipo.
En el caso de la Caja Costarricense de Seguro Social, que es el mayor prestador de servicios de salud del país, se pudo
obtener dicha información con las autoridades correspondientes, pero resulta complicado.
Côte d’Ivoire

77.91 45
Lower-Middle
12.4%
aged 30-70 yrs from 21.70% >10% (>25%) of
(3.4%)
income (%):i
Human Development
0.54
Years

(0.35): 21.2 (112)
low
rank:f
High-technology
ICT Development
3.1 (131) exports (% of 11.20%
Index (rank):g

Website: —
Ministry of health responsible for health technology policy implementation: Direction des Infrastructures, de l’Equipement
et de la Maintenace.

Lists available: Yes, but it is only a recommendation Les listes d’acquisition provient du Plan
National de développement Sanitaire
Unit: Direction des Infrastructures, de l’Equipement et de la Maintenace (DIEM). PNDS.
Website: —
Lists available: Yes Document de travail de la Direction des
Infraestructures, de l’Equipement et de
Website - hospitals: — la Maintenance (DIEM): ListeTypeEquip
CHR_HG_CSU_CSR .
Lists available: — Les procédures et directives sont dans
le mannuel de directives à l’attention du
Website: — personnel des des établissemnts de soins.
il n’existe pas de liste spécifique à un
domaine ou un programme de santé.
e
—
Website(s): —

Name of regulatory agency: Direction des Infrastructures, de l’Équipement, du —
Matériel et de la Maintenance.
Website(s): —
Contact: Dr. Duncan Rachel Email: rachdunc2002@yahoo.fr
84
WHO African Region
Côte d’Ivoire
Website: —

Procurement
Donations Il s’agit du Guide de la Direction des
Policy or guideline: No Website: — Marchés Publics.
Website: —
Density per
population
Mammograph:α,* 0 0

Unit/Department: Direction des infrastructures de l’équipement et de la maintenance. Unit website: —
Contact name: Mr. Tra Bi Irié Contact email: trabidenis@yahoo.fr
Type of inventories available: None La base nationale de données n’est pas
fonctionnelle.
Website: —

Contacts
Name: Dr. Tra Bi Yrié Name: Dr. Jean-Marie Vianny Yameogo
Email: denis.trabi@yahoo.fr Email: yameogoj@who.int
Name: — Name: Dr. Théodore Yao Kouadio
Email: — Email: yaot@ci.afro.who.int
Croatia

4.55 73
High
2.8%
aged 30-70 yrs from 16.10% >10% (>25%) of
(0.3%)
income (%):i
Human Development
0.85
Years

(0.78): 37.3 (41)
very high
rank:f
High-technology
ICT Development
7.2 (36) exports (% of 8.30%
Index (rank):g

Website: http://www.aaz.hr/
http://narodne-novine.nn.hr/clanci/sluzbeni/2006_06_72_1719.html
Language(s): Croatian
Ministry of health responsible for health technology policy implementation: Agency for Quality and Accreditation in
Health.

Unit: —
Website: —
Website - hospitals: http://narodne-novine.nn.hr/clanci/sluzbeni/2004_07_90_1694.html :
http://narodne-novine.nn.hr/clanci/sluzbeni/2008_04_38_1318.html
Website - laboratories: https://www.halmed.hr/en/Medicinski-proizvodi/Baza-medicinskih-
proizvoda/Pretraga-po-proizvodima/#rezultati
In 2007 the Ministry of Health and
National list for specific clinical interventions/emergencies: Social Welfare issued Ordinance on
the organization and work procedures
Lists available: — of the Ministry of Health and Social
Website: — Welfare’s Crisis Headquarters (http://
narodne-novine.nn.hr/clanci/

sluzbeni/2007_05_46_1563.html) which
e
HTA is focused on pharmaceutics, not
HTA unit/department includes the assessment of medical devices: No specifically in medical devices. HTA has
Unit/department: Agency for Quality and Accreditation in Health. three partners: the MoH, Health Insurance
Fond (HIF) and Croatian Institute of Public
Website(s): http://aaz.hr/sites/default/files/hrvatske_smjernice_za_procjenu_zdravstvenih_ Health (CIPH). However systematic use
tehnologija.pdf of HTA to support healthcare decision-
http://www.miz.hr/; www.hzzo.hr making is in still in process, but expected
over the next years.
http://www.hzjz.hr/english/
Contact: Mr. Renato Mittermayer Email: renato.mittermayer@aaz.hr

Name of regulatory agency: Agency for Medical Products and Medical Devices, —
Subunit for Medical Devices.
Website(s): —
Contact: Mr. Krunoslav Kranjcec Email: krunoslav.kranjcec@almp.hr
Other agency’s website: https://narodne-novine.nn.hr/
86
WHO European Region
Croatia
Website: https://www.halmed.hr/Medicinski-proizvodi/Upute-za-podnositelje-zahtjeva-41/ of MD representatives (of both the
Proizvodnja-medicinskih-proizvoda/ national MoH and the national agencies)
Procurement
Policy or guideline: Yes Website: http://www.zdravlje.hr/
National level procurement: Yes Website: http://www.zdravlje.hr/
Donations Ministry of Health and Social Welfare
Policy or guideline: Yes currently conducts joined procurement
of several groups of medical devices for
Website: http://narodne-novine.nn.hr/clanci/sluzbeni/2009_12_151_3696.html more than 20 hospitals in the Republic
Technical specifications of Croatia. The procurement procedure
is managed by the expert divisions
Technical specifications to support procurement or donations: No within the Ministry in collaboration with
Publically available: — all hospitals included in the Procurement
Plan and top medical experts for
Website: — every group of the equipment. Due to
continuous advancement in medical
devices technology, a special commission
Density per
Medical equipment
is formed before every procurement
Total 1,000,000 procedure. The commission defines the
population required technical specifications of the
device based on the most recent available
Magnetic Resonance Imaging:α 31 7.23 data.

Unit/Department: Directorate for Financial Affairs. Unit website: https://zdravstvo.gov.hr/
Contact name: Ms. Antoaneta Bilic Contact email: antoaneta.bilic@mzss.hr
Type of inventories available: None The Ministry of Health and Social Welfare
has a national informal and internal
Website: — inventory for medical devices in all public
Use of management software: No Software name: — health institutions. This inventory is
used mainly for analytical purposes and
planning strategies within the Ministry. In
2008 Croatian National Institute of Public
Health, as part of a pilot project under
Number of biomedical/clinical engineers professionals in the country:γ 250 EUROSTAT guidelines, made an inventory
of 10 most expensive medical devices
(MRI, Computed Tomography, Linear
Contacts Accelerator, etc.).

Name: — Name: Dr. Iva Pejnovic Franelic
Email: — Email: pejnovici@who.int
Name: Ms. Antoaneta Bilic Name: —
Email: antoaneta.bilic@mzss.hr Email: —
Cuba

5.11 80
Upper-Middle
aged 30-70 yrs from 16.60% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
2.9 (137) exports (% of —
Index (rank):g

Website: https://www.gacetaoficial.gob.cu/pdf/GO_O_064_2008.rar
Ministry of health responsible for health technology policy implementation: Ministry of Health of Cuban Republic

Unit: Medical Devices Department of CECMED (Centro para el Control Estatal de
Medicamentos, Equipos y Dispositivos Médicos)
Website: —
Lists available: Yes Existe un listado de modelo de
equipamiento médico destinado para cada
Website - hospitals: http://dirinstituciones.sld.cu nivel de atención. No está refrendado en
ninguna web (no disponible).
Website - laboratories: http://dirinstituciones.sld.cu
Lists available: Yes Cada especialidad médica tiene
establecidas normas y programas a
Website: — través de las recomendaciones de los
grupos nacionales y apoyo del Consejo
de Sociedades Científicas. En cuanto a
e
National health technology assessment unit las listas para diferentes enfermedades
It also exists the Department of Innovation
HTA unit/department includes the assessment of medical devices: Yes and Evaluation of Health Technologies
Unit/department: CECMED/ Medical Devices Department/ Section of Conformity attached to the National Directorate of
Science and Technology of the Ministry of
Assessment Medical Devices Public Health (MINSAP). Evaluations are
Website(s): https://www.cecmed.cu/content/indicaciones-para-el-registro made mainly for pharmaceutics not for
medical devices.
Contact: Dr. Mario César Muñiz Ferrer Email: mario@cecmed.cu

Name of regulatory agency: Centro para el Control Estatal de Medicamentos, En el caso de los medios de diagnóstico
Equipos y Dispositivos Médicos (CECMED) in vitro, estos son regulados y atendidos
en el Centro de Control estatal de
Website(s): https://www.cecmed.cu Medicamentos, Equipos y Dispositivos
Contact: MSc. Olga Lidia Jacobo Casanueva Email: olga@cecmed.cu Medicos (CCEEM).
Name(s) of other regulatory agency eg. for radiation equipment etc.: Agencia de
Energía Nuclear y Tecnologías de avanzada (AENTA); Oficina Nacional de Regulación y Seguridad Ambiental (ORASEN),
Centro de Protección e Higiene de las Radiaciones (CPHR)
Other agency’s website: http://aenta.cu
http://www.cphr.edu.cu
88
Cuba
C3D4 Official nomenclature system for medical devices: Yes Type: More than one system It is use the SUCNEM, a nationally
Use: For procurement purposes developed nomenclature, based on the
Universal Medical Device Nomenclature
Website: https://www.cecmed.cu/ System (UMDNS) and the Global Medical
http://www.electromedicina.sld.cu Device Nomenclature (GMDN)

Procurement
Policy or guideline: Yes
Website: http://legislacion.sld.cu/index.php?P=DownloadFile&Id=552 Medical device incorporation
National level procurement: Yes Website: http://www.sld.cu/
Basado en la política de salud, los
Donations equipos médicos deben contar con el
Registro Sanitario para su utilización
Policy or guideline: Yes Website: http://www.cecmed.cu/sites/default/files/adjuntos/ en el Sistema Nacional de Salud (see:
Reglamentacion/res_cecmed-185-2013_opt.pdf www.bvscuba.sld.cu) y en la Gaceta
Technical specifications Oficial de la República de Cuba (www.
gacetaoficial.cu). Para el proceso de
Technical specifications to support procurement or donations: Yes importación se realiza una evaluación
Publically available: No entre las autoridades competentes donde
se efectúa previamente un análisis entre
Website: — asistencia médica y electromedicina. La
fichas técnicas para facilitar el proceso de
adquisición no están publicadas.
Density per
population

Unit/Department: Centro de Ingeniería Clínica y Electromedicina Unit website: http://www.electromedicina.sld.cu
Contact name: Ing. Zholem Jorge Isaac Contact email: director@electromedicina.sld.cu
Type of inventories available: National functional inventory for medical equipment El Programa de Informatización de la
Salud se encuentra en fase de desarrollo.
Website: https://instituciones.sld.cu/sigicem There are 3 types of inventory for medical
Use of management software: Yes Software name: SIGICEM (Sistema de Gestión equipment: National for high cost
technologies (such as MRI, CT or PET
para la Ingeniería Clínica y Electromedicina) scanners), National for medical equipment
and National functional for medical
equipment.
Contacts
Name: — Name: Dr. José Gerardo Moya
Email: — Email: moyajose@paho.org
Name: Dr. Mario César Muñiz Ferrer Name: Dra. Lizette Perez
Email: mario@cecmed.cu Email: perezliz@paho.org
General comments (...Annex 1): En términos de aclaración general indicamos que en Cuba, como es conocido,
el Sistema de Salud tiene características de ser único, centralizado, público, gratuito y universal, refrendado en la
Constitución de la República. La demanda de equipos médicos se realiza sobre la base de requirimientos acorde al
Cyprus

2.77 79
High
16.1%
aged 30-70 yrs from 8.20% >10% (>25%) of
(1.5%)
income (%):i
Human Development
0.89
Years

(0.81): 45.7 (29)
very high
rank:f
High-technology
ICT Development
7.8 (28) exports (% of 19.90%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
Pharmaceutical Services within the Ministry
HTA unit/department includes the assessment of medical devices: No of Health performs HTA evaluation of
Unit/department: — pharmaceutics.
Website(s): https://www.moh.gov.cy/moh/phs/phs.nsf/home_en/home_en?openform

Name of regulatory agency: Cyprus Medical Devices Competent Authority. —
Website(s): —
Contact: Ms. Androulla Stylianou Email: —
90
WHO European Region
Cyprus
Website: https://www.moh.gov.cy/moh/mphs/mphs.nsf/page21_en/page21_ of MD representatives (of both the
en?OpenDocument national MoH and the national agencies)
Procurement
Donations Procurement guidelines apply to the Public
Policy or guideline: Yes Website: — Sector only.
Website: —
Density per
population

Website: —

Contacts
Name: Ms. Andoulla Stylianou Name: —
Email: cymda@mphs.moh.gov.cy Email: —
Name: — Name: —
Czechia

2.92 78
High
2.2%
aged 30-70 yrs from 14.30% >10% (>25%) of
(0.1%)
income (%):i
Human Development
Years

48.3 (24)
rank:f
High-technology
ICT Development
7.2 (43) exports (% of 20.80%
Index (rank):g

Website: —
Language(s): —

Unit: VZP CR (General Health Insurance Company).
Website: http://www.vzp.cz/
Website - hospitals: https://www.mzcr.cz/
Website - laboratories: https://www.mzcr.cz/doporucujici-a-interpretacni-dokumenty-
meddev/
https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/ZdravotnickyProstredek
Website: https://www.mzcr.cz/doporucujici-a-interpretacni-dokumenty-meddev/
e
There are HTA activities in pharmaceutics,
HTA unit/department includes the assessment of medical devices: No not specifically for medical devices.
Website(s): http://www.mzcr.cz/en/
https://www.mzcr.cz/ministerstvo-zorganizovalo-dalsi-seminar-venovany-hta/
https://www.niszp.cz/en

Name of regulatory agency: Ministry of Health. —
Website(s): https://www.mzcr.cz/information-on-legal-provisions-regulating-the-field-of-
medical-devices/
Contact: Ms. Karolina Pestova Email: karolina.pestova@mzcr.cz
Name(s) of other regulatory agency eg. for radiation equipment etc.: State Institute
for Drug Control.
Other agency’s website: https://www.sujb.cz/en/
92
WHO European Region
Czechia
Website: — of MD representatives (of both the
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: Ms. Karolina Pestova Name: Dr. Srdan Matic
Email: karolina.pestova@mzcr.cz Email: matics@who.int
Name: Mr. Jan Zofka Name: —
Email: zofka@uzis.cz Email: —
Democratic People’s Republic of Korea

16.5 68
Low
aged 30-70 yrs from 23.90% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—): — (—)
rank:f
High-technology
ICT Development
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Unit/department: National Evidence-based healthcare Collaborating Agency
(NECA).
Website(s): https://vortal.htai.org/index.php?q=node/379

Name of regulatory agency: Department of Medical Device Management and —
Production.
Website(s): —
94
Democratic People’s Republic of Korea

C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed —
Use: Not specified
Website: —

Procurement
Donations —
Website: —
Density per
population


Unit/Department: Department of Medical Equipment. Unit website: —
Website: —

Contacts
Name: — Name: Dr Mohamed Jamsheed
Email: — Email: jamsheedm@who.int
Name: — Name: —
Democratic Republic of the Congo

81.18 39
Low
4.8%
aged 30-70 yrs from 24.10% >10% (>25%) of
(0.6%)
income (%):i
Human Development
0.48
Years

(0.34): — (—)
low
rank:f
High-technology
ICT Development
1.6 (171) exports (% of —
Index (rank):g

Website: —
Language(s): —

Lists available: No Il existe des listes de materiel dressé au
niveau periphérique approuvé (district
Unit: — sanitaire ). Pour le niceu intermediaires
et niveau tertiaire cette liste est en
Website: — élaboration.
Website: —
e
—
Website(s): —

Name of regulatory agency: La Direction des laboratoires de Santé / Ministère de la La Direction des laboratoirs de Sante
Santé. veuille surtout au respect des normes de
autres equipements des laboratoires et
Website(s): https://www.minisanterdc.cd/ des services d’imagerie medicales. Tandis
Contact: Mr. Daniel Ngeleka Mutolo Email: dangelemutolo@yahoo.fr la Direction des Equipements et Materiels
Medicaux s’occupes des autres materiel
Name(s) of other regulatory agency eg. for radiation equipment etc.: Direction des
laboratoirs de Sante; Direction des Equipements et Materiels medicaux, and Comite National de Protection Contre les
rayonments ionisants (CNPRI).
Other agency’s website: https://www.iaea.org/newscenter/news/democratic-republic-of-the-congo-signs-a-country-programme-
framework-cpf-for-2018-2022
96
WHO African Region

C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified La nomenclature officielle n’existe pas.
Tout ce qui est à portée de main et selon
Website: — les circonstances est utilisé.

Procurement
Donations En R.D.Congo, les achats se font à tous
Policy or guideline: No Website: — les niveaux. L’Etat n’a pas pu reglementer
ce secteur les achats se font à tous les
Technical specifications niveaux et surtout les bailleurs de fonds
Technical specifications to support procurement or donations: No pour leurs programmes spécifiques qu’ils
appuient. Le directives à ce niveau sont
Publically available: — fonction d’un appel offre, c’est en ce
moment que celui qui lance l’offre dresse
Website: — un certains critères des dispositifs qu’il veut
Density per
population

Unit/Department: Direction des Equipements et Materiels Médicaux. Unit website: —
Contact name: Mr. Ngilo Eagbali Contact email: —
Type of inventories available: National inventory for medical equipment On est dans le processus de creér de
pool de maintenance avec des ingenieurs
Website: — sanitaires et de rehabiliter les ateliers qui
Use of management software: No Software name: — existent . Il y a un programme de formation
des ingenieurs et des utilisateurs.

Contacts
Name: Mr. Malaba Munyyanji Cleophas If Name: Dr. Yokouidé Allarangar
Email: malabac@yahoo.fr Email: afwcocd@who.int
Name: Mr. Ngilo Eagbali Name: Dr. Anastasie Mulumba M.
Email: Ngilozagbali@yahoo.fr Email: mulumbaa@who.int
General comments (...Annex 1): En tant pays post-conflit, dans le processus de l’organisation de son système
national de santé, le gouvernement dispose dejà d’une strategie de renforcement du système de santé qui est une
strategie sectorielle. Ensuite, le pays vient de se doter d’un plan stragegique de développement sanitaire pour 5 ans avec
un cadre des dépenses à moyen terme ou toutes ces technologies sont planifiées.
Denmark

3.61 85
High
2.9%
aged 30-70 yrs from 10.80% >10% (>25%) of
(0.5%)
income (%):i
Human Development
0.94
Years

(0.88): 57.5 (6)
very high
rank:f
High-technology
ICT Development
8.7 (4) exports (% of 12.00%
Index (rank):g

Website: —
Language(s): Danish
Ministry of health responsible for health technology policy implementation: Lægemiddelstyrelsen (Danish Medicines
Agency).

Unit: —
Website: —
Lists available: No In the case of lists for different diseases
and situations, there are some more
Website: — general plans, but no specific medical
devices recommended.
e
—
Unit/department: HTA unit within the Danish Health Authority.
Website(s): https://www.sst.dk/en
https://laegemiddelstyrelsen.dk/en/

Name of regulatory agency: Lægemiddelstyrelsen / Danish Medicines Agency. —
Website(s): https://laegemiddelstyrelsen.dk/
Contact: Ms. Ellen Jespersen Email: eje@dkma.dk
Name(s) of other regulatory agency eg. for radiation equipment etc.: The Danish
Health and Medicines Authority.
Other agency’s website: https://www.sst.dk/da/Opgaver/Straalebeskyttelse
98
WHO European Region
Denmark
Website: https://laegemiddelstyrelsen.dk/ of MD representatives (of both the
Donations —
Website: —
Density per
population

Type of inventories available: National inventory for medical equipment The National Institute of Radiation
Protection is in charge. The inventory
Website: www.sis.dk covers all x-ray equipment, equipment for
Use of management software: Yes Software name: Several systems: MEDUSA, nuclear medicine and radiation therapy.
MERIDA, QAMAP, REMEDY and more.

Contacts
Name: Ms. Nina Moss Name: Dr. Hans Kluge
Email: nmo@sum.dk Email: eurordletters@who.int
Name: Mr. Mads Frellsen Name: —
Email: maf@sst.dk Email: —
General comments (...Annex 1): The National Board of Health is issuing some Health Technolgy Assessments,
including but not limited to medical devices. Only a minority of technologies are handled, so this is regarded as being
outside the scope of the Policy section.
Djibouti

55.88 48
Lower-Middle
aged 30-70 yrs from 22.00% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
2 (158) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
The development of the HTA unit is in
HTA unit/department includes the assessment of medical devices: No progress, as well as the human resources
Unit/department: — to fill the workforce gap within the MoH.
Website(s): https://sante.gouv.dj/

Website(s): —
100
Djibouti
Website: —

Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: — Name: Dr. Reinhilde Therese Van De Weerdt
Email: — Email: vanr@who.int
Name: — Name: —
Dominica

35.45 67
Upper-Middle
aged 30-70 yrs from — >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
5.7 (77) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
Unit/department: Biomedical Department, PMH.
Website(s): —

Website(s): —
102
Dominica
Website: —

Procurement
Donations —
Website: —
Density per
population
Radiotherapy:β 0 0

Unit/Department: Central Medical Stores. Unit website: —
Contact name: Mrs. Theresa Shillingford Contact email: cms@cwdom.dm
Type of inventories available: None The Software is currently awaiting for the
setting-up.
Website: —

Contacts
Name: Dr. Ruby Josephine Blanc Name: Dra. Amalia Del Riego
Email: blancruby@hotmail.com Email: delriegoa@paho.org
Name: Mrs. Theresa Shillingford Name: Dr. Cecilia Acuna
Email: cms@cwdom.dm Email: acunamar@paho.org
General comments (...Annex 1): A manual exists in draft form to govern issues related to medical devices. It is still
supposed to have a final review to begin the process of it’s adoption and implementation.
Dominican Republic

33.76 66
Upper-Middle
aged 30-70 yrs from 19.10% >10% (>25%) of — (—)
income (%):i
Human Development
Years

25.1 (90)
rank:f
High-technology
ICT Development
4.5 (106) exports (% of 7.00%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Unit/department: Superintendencia de Salud y Riesgos Laborales (SISALRIL) y
Electromedicina MoH.
Website(s): https://www.sisalril.gob.do/
https://redetsa.bvsalud.org/perfilesdepaises/perfil-de-paises/
Contact: Madeline Melissa Martínez García Email: m.martinez@sisalril.gob.do

Name of regulatory agency: Viceministerio de Garantia de la Calidad. La Ley General de Salud 42-01 y
Website(s): https://digemaps.msp.gob.do/menu/ el Reglamento de Medicamentos
Decreto 246-06 son el marco legal que
https://www.msp.gob.do/web/ fundamenta el accionar del Viceministerio
Contact: Ms. Cristina Hernández Email: — de Garantía de la Calidad.
Name(s) of other regulatory agency eg. for radiation equipment etc.: Ministerio de
Salud Pública.
Other agency’s website: https://www.msp.gob.do/web/
104
Dominican Republic
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified No existe una nomenclatura oficial. Sin
embargo, existe una propuesta que data
Website: — del año 2006 que respondió a un proyecto
de mantenimiento preventivo de equipos
médicos.
Procurement
National level procurement: Yes Website: https://msp.gob.do/web/
Donations En cuanto a la adquisión solo existen
Policy or guideline: Yes Website: — recomendaciones dadas en fichas
técnicas y de acuerdo a la complejidad del
Technical specifications establecimiento.
Website: —
Density per
population

Unit/Department: Electromedicina. Unit website: —
Contact name: Mr. Juan del Rosario Contact email: juan23955@hotmail.com
Website: —

Contacts
Name: — Name: Dr. Olivier Ronveaux
Email: — Email: ronveauoli@paho.org
Name: Mr. Juan del Rosario Name: Dr. Roger Montes
Email: juan23955@hotmail.com Email: montesr@paho.org
Ecuador

12.95 80
Upper-Middle
10.3%
aged 30-70 yrs from 11.00% >10% (>25%) of
(2.4%)
income (%):i
Human Development
0.76
Years

(0.62): 24.1 (99)
high
rank:f
High-technology
ICT Development
4.8 (97) exports (% of 5.50%
Index (rank):g

Website: https://aplicaciones.msp.gob.ec/salud/archivosdigitales/documentosDirecciones/dnn/archivos/AM-00000113-2016%20
OCT%2011.pdf
Ministry of health responsible for health technology policy implementation: Ministerio de Salud Pública-Autoridad
Sanitaria Nacional

Unit: —
Website: https://www.salud.gob.ec/ecuador-cuenta-con-lista-y-aplicativo-para-la-
adquisicion-de-dispositivos-medicos-de-calidad-seguros-y-eficaces/
Lists available: Yes Estatuto del MSP; Licenciamiento por Area
en el I y II nivel.
Website - hospitals: https://www.salud.gob.ec/
Website - laboratories: https://www.salud.gob.ec/
https://www.controlsanitario.gob.ec/base-de-datos/
Lists available: Yes Reglamento para el registro y control
sanitario de dispositivos médicos; reactivos
Website: http://www.investigacionsalud.gob.ec/ bioquímicos y de diagnóstico y productos
dentales. Reg. Oficial 573 del 20 de abril
de 2009.
e
There are HTA activities for health
HTA unit/department includes the assessment of medical devices: Yes products, not specified for medical
Unit/department: Coordinación General de Desarrollo Estratégico en Salud devices.
(Dirección Nacional de Inteligencia de la Salud).
Website(s): https://www.salud.gob.ec/direccion-de-inteligencia-de-la-salud/
Contact: Ms. Ruth Lucio Email: ruth.lucio@msp.gob.ec

Name of regulatory agency: Coordinación Nacional de Desarrollo Estratégico, Eco. Ruth Lucio, Coordinadora Nacional de
Dirección de Inteligencia and Instituto Nacional de Higiene y Medicina Tropical. Desarrollo Estratégico en Salud Dirección
Nacional de Vigilancia y Control Sanitario
Website(s): https://www.salud.gob.ec/ en lo relativo a Publicidad y vigilancia. Dr.
https://www.controlsanitario.gob.ec/ Liliana Sacoto es la Directora Nacional. Asi
como la Dra. Amelia Prieto del Instituto
Contact: Ms. Ruth Lucio Email: — Nacional de Higiene y Medicina Tropical.
Name(s) of other regulatory agency eg. for radiation equipment etc.: Agencia
Nacional de Regulación, Control y Vigilancia Sanitaria.
Other agency’s website: https://www.controlsanitario.gob.ec/
106
Ecuador
C3D4 Official nomenclature system for medical devices: Yes Type: More than one system For MD traceability purposes will be
Use: For regulatory and procurement purposes taken as a reference the Universal Medical
Devices Nomenclature System (UMDNS)
Website: https://www.controlsanitario.gob.ec/wp-content/uploads/downloads/2017/01/ developed by Emergency Care Research
Resoluci%C3%B3n_ARCSA-026-YMIH-Dispositivos-M%C3%A9dicos.pdf Institute (ECRI). In case that UMDNS does
not have a specific code for a MD, it will
be taken as an alternative nomenclature,
Medical device incorporation the Global Medical Devices Nomenclature
developed by GMDN Agency.
Procurement
National level procurement: Yes Website: https://www.salud.gob.ec/direccion-nacional-
de-medicamentos-y-dispositivos-medicos/
Las políticas de adquisición están en
Donations proceso de implementación por la
Dirección de Inteligencia y Economía de
Policy or guideline: Yes Website: https://www.salud.gob.ec/direccion-nacional-de- la salud.
medicamentos-y-dispositivos-medicos/ Programa Mi hospital: Adquisición de
equipos para 8 hospitales declarados en
Technical specifications emergencia sanitaria.
Website: —
Density per
population

Unit/Department: Red de Hospitales. Unit website: https://www.salud.gob.ec/
Contact name: Dr. Luis Paredes Contact email: luis.paredes@msp.gob.ec
Website with publically available technical specifications: https://www.controlsanitario.gob.ec/wp-content/uploads/
downloads/2014/04/dispositivos-medicos-y-dentales.pdf
https://www.controlsanitario.gob.ec/wp-content/plugins/download-monitor/download.php?id=7148&force=1
Type of inventories available: National inventory for medical equipment Se está actualizando el inventario de los
Hospitales declarados en emergencia.
Website: — Hay “National inventory only for high cost
Use of management software: No Software name: — technologies (such as MRI, CT or PET
scanners)” tambien.

Contacts
Name: Ms. Betzabé Tello Name: Dr. Oscar Martin Barreneche
Email: betzabe.tello@msp.gob.ec Email: barreneosc@paho.org
Name: Dr. Luis Paredes Name: Dr. Javier Uribe
Email: luis.paredes@msp.gob.ec Email: uribejav@paho.org
General comments (...Annex 1): La regulación y

el control de la publicidad de dispositivos médicos se realiza mediante el “Reglamento para la publicidad y promoción de
medicamentos en General, Productos Naturales procesados de uso medicinal, medicamentos homeopáticos y dispositivos
médicos”. Reg. Oficial 416, acuerdo ministerial 179 del 30 de marzo de 2011.
Egypt

19.46 70
Lower-Middle
26.2%
aged 30-70 yrs from 28.00% >10% (>25%) of
(3.9%)
income (%):i
Human Development
Years

24.2 (96)
rank:f
High-technology
ICT Development
4.6 (103) exports (% of 2.30%
Index (rank):g

Website: —
Language(s): Arabic and English
Ministry of health responsible for health technology policy implementation: Geographical Unit of Health Information (GIS),
Aantrz National Health Information: administration of medical devices.

Unit: —
Website: —
Lists available: Yes Were counted by the sector ministry
and therapeutic medicine, the National
Website - hospitals: — Information Center Ministry
Website: —
e
A pharmacoeconomics unit was officially
HTA unit/department includes the assessment of medical devices: No established in 2011 under the Central
Unit/department: — Administration of Pharmaceutical Affairs
within the Ministry of Health, but HTA is not
Website(s): https://gah.gov.eg/indexenglish.php obligatory for pricing or reimbursement.
Contact: — Email: — However, the recent universal health
insurance law from 2018 mandates the
Committee includes a biomedical or clinical engineer: — representation of health economists in the

Website(s): —
Name(s) of other regulatory agency eg. for radiation equipment etc.: Egyptian
Nuclear and Radiological Regulatory Authority (ENRRA).
Other agency’s website: https://gnssn.iaea.org/main/ANNuR/Activity%20Documents%20%20Public/6th%20ANNuR%20Plenary%20
Meeting/Egypt1.pdf
108
Egypt
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed Used in the database of geographical
Use: Not specified information system health.
Website: https://www.edaegypt.gov.eg/

Procurement
Donations Management of medical equipment and
Policy or guideline: Yes Website: — hospital management. Curative medicine
sector and management of medical
Technical specifications devices.
Website: —
Density per
population


Unit/Department: Quality Management. Unit website: —
Type of inventories available: National inventory for medical equipment Database of geographical information
system health.
Website: —

Contacts
Name: Dr. Sohier Saad Botrous Attalla Name: Dr. Naeema Al Gasseer
Email: ssb_attalla@yahoo.com Email: algasseern@who.int
Name: — Name: —
General comments (...Annex 1): Concerning the Infrastructure section: the proposed names are not totally
compatible with ours. Thus, the number of units is under the Ministry of Health only and is not confined to Tfsalia to the
private sector in 2010.
El Salvador

12.88 76
Lower-Middle
1.7%
aged 30-70 yrs from 10.70% >10% (>25%) of
(0.3%)
income (%):i
Human Development
0.67
Years

(0.53): 24.8 (92)
medium
rank:f
High-technology
ICT Development
3.8 (119) exports (% of 5.10%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Lists available: Yes Norma técnica para el diseño y
equipamiento de Casas de Salud.
Website - hospitals: http://asp.salud.gob.sv/regulacion/pdf/norma/Norma_diseno_y_
equipamiento_casas_salud.pdf
Website - laboratories: https://www.medicamentos.gob.sv/index.php/es/servicios-m/en-
linea/expediente-electronico-de-insumos-medicos
Nomenclature systems used for devices and tests: — Specific lists comments (...Annex 1):
National list for specific clinical interventions/emergencies: Tomadas de la pagina web del MINSAL
(ver link proporcionado). Norma
Lists available: Yes técnica para radiología diagnóstica e
Website: http://asp.salud.gob.sv/ intervencionista; Norma técnica para uso
de fuentes radiactivas en braquiterapia;
http://www.salud.gob.sv/ Norma técnica para la operación de
equipos de teleterapia; Norma técnica
uso de fuentes radiactivas no selladas
e
—
Unit/department: Dirección Nacional de Medicamentos and Instituto Salvadoreño
de Seguro Social
Website(s): https://www.isss.gob.sv/
Contact: Haryes Funes Email: haryes.funes@medicamentos.gob.sv

Name of regulatory agency: Dirección Nacional de Medicamentos El departamento está a cargo del
Website(s): https://www.medicamentos.gob.sv/index.php/es/servicios-m/descargables/ Dr. Rivera, Director de Regulación y
Legislación en Salud del Ministerio de
unidad-de-registro-de-dispositivos-medicos Salud.
Contact: Lic. Francisco Bosco Cortez Morales
Email: insumos.medicos@medicamentos.gob.sv
Name(s) of other regulatory agency eg. for radiation equipment etc.: Dirección de Protección Radiológica (DPR).
Other agency’s website: https://www.salud.gob.sv/direccion-de-proteccion-radiologica/
110
El Salvador
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified El catálogo desarrollado es de equipo
médico en general y sólo es para fines de
Website: — compra. No existe distinción o clasificación
de equipos de tecnología médica por
su aplicación o incidencia en la salud del
Medical device incorporation paciente.
Procurement
Donations —
Website: —
Density per
population

Unit/Department: Unidad Nacional de Radiaciones Ionizantes. Unit website: —
Contact name: Ms. Carolina de Rivera Contact email: —
Type of inventories available: National inventory only for high cost technologies Para el control de equipos con fuente
de radiaciones ionizantes, la Dirección
(such as MRI, CT or PET scanners) de Regulación a través de la Unidad
Website: https://www.salud.gob.sv/direccion-de-proteccion-radiologica/ Reguladora de Radiaciones Ionizantes
https://www.medicamentos.gob.sv/index.php/es/servicios-m/descargables/urim-m (UNRA) tiene el inventario de los equipos
como TC, Rayos X, Angiografía, Gamma
Use of management software: No Software name: — Cámara, etc. Autorizados a nivel nacional
en la actualidad, se remitirá el listado
actualizado a la fecha a la OMS.
Contacts
Name: Lic. Sulay Stefanni Mejía Campos Name: Dr. Giovanni Escalante Guzman
Email: cooperacion@medicamentos.gob.sv Email: gescalante@paho.org
Name: Ms. Carolina de Rivera Name: Dr. Laura Ramirez
Email: — Email: lramirez@paho.org
General comments (...Annex 1): Las respuestas proporcionadas corresponden exclusivamente a la información
disponible en la Unidad de Proyectos del Ministerio de Salud Pública y Asistencia Social. Agradecemos permitirnos
participar de tan importante encuesta que nos permite establecer un enlace que estamos seguros contribuirá a mejorar
nuestra gestión en la planificación, evaluación, adquisición y mantenimiento de los dispositivos médicos de nuestro
sistema nacional de salud; así como a contribuir en el desarrollo de una política nacional de tecnología sanitaria en El
Equatorial Guinea

78.49 43
Upper-Middle
aged 30-70 yrs from 22.10% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
1.9 (163) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
Website(s): —

Website(s): —
112
WHO African Region
Equatorial Guinea
Website: —

Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: — Name: Dr. George Fom Ameh
Email: — Email: amehg@who.int
Name: — Name: —
Eritrea

39.27 50
Low
aged 30-70 yrs from 26.80% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
1 (176) exports (% of —
Index (rank):g

Website: —
Ministry of health responsible for health technology policy implementation: Department of Regulatory Services, Medicine
and Medical Devices Control Division.

Unit: —
Website: —
Lists available: Yes Ministry of Health, Department of
Regulatory Services, Medicine and Medical
Website - hospitals: — Devices Control Division.
Website: —
e
—
Website(s): —

Name of regulatory agency: Ministry of Health, Department of Regulatory Services. —
Website(s): —
Contact: Mr. Eyassu Bahta Email: bahtassy@gmail.com
114
WHO African Region
Eritrea
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified Official nomenclature system for medical
devices is currently on the process of
Website: https://shabait.com/ development.

Procurement
Donations —
Website: —
Density per
population
Radiotherapy:β 0 0

Unit/Department: Department of Health services. Unit website: —
Contact name: Dr. Brhane Debru Contact email: —
Type of inventories available: National inventory for medical equipment National medical devices inventory on
the six zones has started in 2008 and,
Website: — currently, it is in the process of finalization
Use of management software: No Software name: — (only one zone is partially remaining).

Contacts
Name: Mr. Gherezghier Habtu Name: Dr. Martins Ovberedjo
Email: wedirebi22@gmail.com Email: ovberedjom@who.int
Name: Dr. Brhane Debru Name: —
Estonia

2.11 78
High
aged 30-70 yrs from 14.90% >10% (>25%) of — (—)
income (%):i
Human Development
0.89
Years

(0.83): 48.3 (25)
very high
rank:f
High-technology
ICT Development
8.1 (17) exports (% of 9.30%
Index (rank):g

Website: —
Language(s): —

Lists available: Yes The list about reimbursed medical
devices used in outpatient conditions is
Unit: — available on web-site (second link) Medical
devices used in inpatient conditions are
Website: https://www.riigiteataja.ee/index.html financed though the prices of healthcare
https://www.riigiteataja.ee/ert/act.jsp?id=13284086 services (these prices include also costs
https://www.riigiteataja.ee/ert/act.jsp?id=13231527 of workforce, area, etc). List of healthcare
sevices is available on web-site (third link).
Website - hospitals: https://www.riigiteataja.ee/ert/act.jsp?id=13252715
Website - laboratories: https://www.riigiteataja.ee/aktilisa/1300/4201/4006/SOM_m26_
lisa.pdf#
Lists available: Yes Recommended medical devices for
specific procedures are described in
Website: https://www.riigiteataja.ee/ert/act.jsp?id=13252715 diagnostic (and treatment) guidelines.
They are composed and/or approved by
specialists organizations.
e
The HTA for medical products, mainly
HTA unit/department includes the assessment of medical devices: Yes pharmaceutics, and treatments. There is
Unit/department: University of Tartu: Publich Health Department. mention of medical equipment too.
Website(s): https://tervis.ut.ee/en/health-technology-assessment/health-technology-
assessment-estonia
Contact: — Email: dph@ut.ee

Name of regulatory agency: Health Board, Medical Devices Department. —
Website(s): https://www.terviseamet.ee/et
http://www.terviseamet.ee/en/medical-devices.html
Contact: Mr. Andrei Knuut Email: mso@terviseamet.ee
Other agency’s website: https://www.riigiteataja.ee/index.html
116
WHO European Region
Estonia
Website: https://www.terviseamet.ee/en/medical-devices-2/regulatory-controls-medical- of MD representatives (of both the
devices national MoH and the national agencies)
Procurement
Policy or guideline: Yes Website: https://www.riigiteataja.ee/ert/act.jsp?id=13191371
Donations The procurement of medical devices is
Policy or guideline: No Website: — regulated by the Public procurement
law, as well as all other commodities (see
Technical specifications specified website: riigiteataja).
Website: —
Density per
population

Unit/Department: Department of Public Health, University of Tartu. Unit website: http://www.arth.ut.ee/
Website with publically available technical specifications: http://www.arth.ut.ee/
Website: —

Contacts
Name: Ms. Tairi Välinurm Name: Ms. Kristina Köhler
Email: tairi.valinurm@sm.ee Email: kohlerk@who.int
Name: — Name: —
Eswatini

46.64 58
Lower-Middle
aged 30-70 yrs from 35.20% >10% (>25%) of — (—)
income (%):i
Human Development
0.61
Years

(0.43): — (—)
medium
rank:f
High-technology
ICT Development
— (—) exports (% of 0.30%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Lists available: No The list is still being developed by the
Emergency Preparedness Group.
Website: —
e
There is no HTA national unit per se.
HTA unit/department includes the assessment of medical devices: — However, and adaptive HTA has been used
Unit/department: — to inform in areas such as benefits package
in health interventions prioritisations
Website(s): — packages.

Name of regulatory agency: Pharmaceuticals & Medicines, Ministry of Health. —
Website(s): http://www.gov.sz/index.php/3rd-national-health-and-research-conference
118
WHO African Region
Eswatini
Website: —

Procurement
Donations The National guidelines on procurement
Policy or guideline: Yes Website: — are yet to be developed. The unit together
with the bio-medical department forms a
Technical specifications committee that recommends purchasing
Technical specifications to support procurement or donations: No the needed equipment or rather requested
equipment.
Website: —
Density per
population
Radiotherapy:β 0 0

Unit/Department: Biomedical unit. Unit website: —
Contact name: Mr. Leornad Zwane Contact email: magmu@realnet.co.sz
Type of inventories available: National inventory for medical equipment Though this inventory is still under
development, we have only covered
Website: — hospitals and health centres and will
Use of management software: No Software name: — proceed to clinics (health posts for
Swaziland).

Contacts
Name: Dr. Samuel Vusi Magagula Name: Dr. Cornelia Atsyor
Email: magagulasam@gov.sz Email: atsyorc@who.int
Name: Mr. Leornad Zwane Name: —
Email: magmu@realnet.co.sz Email: —
General comments (...Annex 1): Concerning the Infrastructure section: In Swaziland Health Centres may have
more than 20 beds. The referral levels are being defined by the ongoing essential health care package that is being
developed.
Ethiopia

48.71 38
Low
4.9%
aged 30-70 yrs from 17.10% >10% (>25%) of
(1.4%)
income (%):i
Human Development
0.49
Years

(0.35): 18.1 (127)
low
rank:f
High-technology
ICT Development
1.7 (170) exports (% of 61.00%
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Federal Ministry of Health (FMOH).

Lists available: Yes, but it is only a recommendation We have capital and routine medical
device list with technical specification
Unit: Pharmaceutical and Medical Device Directorate, FMOH. categorized with health facility level.
Website: www.moh.gov.et
Nomenclature systems used for devices and tests: Several of the ones mention
above.
Lists available: Yes The list of healthcare facilities is currently
in progress.
Website - hospitals: www.moh.gov.et
Nomenclature systems used for devices and tests: Use of several nomenclatures.
Lists available: No A revision has started for each. It is use the
WHO guidelines and other documents.
Website: www.fmhaca.gov.et
http://www.fmhaca.gov.et/publication/guideline-for-registration-of-medical-devices-2014/
e
An HTA unit is not yet established. Within
HTA unit/department includes the assessment of medical devices: No the FMoH the Pharmaceutical and Medical
Unit/department: Pharmaceutical and medical equipment directorate Device Directorate and HEFA team are
primary driving forces to generate and
Website(s): — promote HTA based evidence. The HEFA
Contact: Mr. Regasa Bayisa Email: regasa.bayisa@moh.gov.et team is tasked with spearheading the
application of evidence-based health
Committee includes a biomedical or clinical engineer: No care decision making by organizing

Name of regulatory agency: Ethiopian Food and Drug Administration (EFDA). Radiation & Protection Authority.
Website(s): https://www.eris.efda.gov.et/; www.fmhaca.gov.et
Name(s) of other regulatory agency eg. for radiation equipment etc.: Radiation &
Protection Authority; Ethiopian standard Agency (ESA)
Other agency’s website: http://www.moh.gov.et/
https://ethiostandards.org/
120
WHO African Region
Ethiopia
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed Nationally developed and adapted
Use: For various purposes from both UMDN and GMDN. This
nomenclature is done by EPSA, ESDA and
Website: www.fmhaca.gov.et FMoH in collaboration with skateholders.
https://epsa.gov.et/featured-services/procurement-list/ The nomenclature is mainly use for
procurement and regulatory purposes.
Established the Public Infrastructure
Medical device incorporation Directorate are now started inventory to
identify the type, source and status of the
Procurement devices.
National level procurement: Yes Website: http://www.moh.gov.et/ejcc/en
Donations The Plan, Monitoring and Evaluation
Policy or guideline: Yes Website: www.fmhaca.gov.et Directorate (PMED), within Federal Ministry
ofHealth (FMOH) is in charge of the
Technical specifications procurement.
Website: https://epsa.gov.et/
https://epsa.gov.et/standard-docs/#1574929031127-db548281-5eb6
Density per
population

Unit/Department: Public Health Infrastructure Directorate; Pharmaceutical and Medical Device Directorate. Unit website:
https://www.fmoh.gov.et
http://www.fmhaca.gov.et/publication/
Contact name: Mr. Regasa Bayisa Contact email: regasa.bayisa@moh.gov.et
Website with publically available technical specifications: https://epsa.gov.et/standard-docs/#1574929031127-db548281-5eb6
http://www.fmhaca.gov.et/publication/
Type of inventories available: National inventory for medical equipment AAU, Tikur Anbesa specialized Hospital
update medical Inventory and Equipment
Website: — history file in 2013.
Use of management software: Yes Software name: MEMIS (Medical Equipment
Management Information System).

Contacts
Name: Mr. Regasa Bayisa Name: Dr. Boureima Hama Sambo
Email: regasa.bayisa@moh.gov.et Email: sambob@who.int
Name: Mr. Mekonnen Engida Name: Mr. Mulugeta Mideksa
Email: mekonen_engda@yahoo.com Email: mulugetamideksa@yahoo.com
General comments (...Annex 1): Concerning

National policy on health technology: National Medical device strategy under development (draft) and National Medical
device directive (final draft) will approved within 3 or 4 months. Concerning the HT national policy, it is stated in the
Fiji

27.43 61
Upper-Middle
aged 30-70 yrs from 37.70% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
4.5 (107) exports (% of 3.90%
Index (rank):g

Website: http://www.health.gov.fj
Ministry of health responsible for health technology policy implementation: Clinical Services MoH HQ.

Lists available: Yes The biomedical catalogue for procurement
can be obtained by the Fiji Health Sector
Unit: Biomedical Engeering Units. Improvement Program (FHSIP).
Website: —
Lists available: Yes CSN & CSP lists can be obtained from
ministry of health, HQ.
Website - hospitals: http://www.health.gov.fj/
Lists available: Yes CSN & CSP. Can be obtained from Ministry
of Health, HQ.
e
—
Website(s): —

Name of regulatory agency: Biomedical Engineering, CWMH. Also, supported by the divisional
Website(s): — biomedical engineering units.
Contact: Mr. Virendra Deo Singh Email: —
Name(s) of other regulatory agency eg. for radiation equipment etc.: Ministry of
Health & Medical Services.
Other agency’s website: http://www.health.gov.fj/
122
Fiji
Website: http://www.health.gov.fj/

Procurement
Policy or guideline: Yes Website: http://www.health.gov.fj/
National level procurement: Yes Website: http://www.health.gov.fj/
Donations Mainly standardization of all medical
Policy or guideline: Yes Website: — equipment as per the national biomedical
catalogue. Also, supported by the Ministry
Technical specifications of Health central procurement centre at Fiji
Technical specifications to support procurement or donations: Yes Pharmaceutical Services.

Density per
population
Radiotherapy:β 0 0

Unit/Department: Biomedical Engineering. Unit website: —
Contact name: Mr. Mohammed Ifraz Contact email: mohammed.ifraz@health.gov.fj
Type of inventories available: National functional inventory for medical equipment BME Equipment Inventory. The inventory
has more than 8,600 items.
Website: —
Use of management software: Yes Software name: EMS, EPICOR.

Contacts
Name: Mr. Virendra Deo Singh Name: Dr. Mark Andrew Jacobs
Email: virendra.singh@health.gov.fj Email: jacobsma@who.int
Name: Mr. Mohammed Ifraz Name: Dr. Wendy Snowdon
Email: mohammed.ifraz@health.gov.fj Email: snowdonw@who.int
Finland

2.31 83
High
6.4%
aged 30-70 yrs from 9.60% >10% (>25%) of
(1.0%)
income (%):i
Human Development
0.94
Years

(0.89): 57 (7)
very high
rank:f
High-technology
ICT Development
7.9 (22) exports (% of 9.20%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Unit/department: FinCCHTA.
Website(s): https://www.ppshp.fi/Tutkimus-ja-opetus/FinCCHTA/Sivut/default.aspx
https://palveluvalikoima.fi/en/recommendations
https://thl.fi/en/web/thlfi-en/about-us

Name of regulatory agency: Finnish Medicines Agency (FIMEA). —
Website(s): http://www.fimea.fi
http://www.valvira.fi
Contact: Mr. Heikki Mattlar Email: heikki.mattlar@fimea.fi
Name(s) of other regulatory agency eg. for radiation equipment etc.: Radiation and
Nuclear Safety Authority (STUK); Ministry of Social Affairs and Health (Radiation Protection).
Other agency’s website: https://www.stuk.fi/web/en
https://stm.fi/en/environmental-health/radiation-protection;
124
WHO European Region
Finland
C3D4 Official nomenclature system for medical devices: Yes Type: Based on EMDN Use: Finland CA will implement the European
For regulatory purposes Medical Device Nomenclature (EMDN)
used by manufacturers/ARs when
Website: https://www.fimea.fi/web/en/medical-devices registering their medical devices in
the EUDAMED database. The EMDN
system will be based on the Italian CND
Medical device incorporation nomenclature system. This will be the
only official nomenclature system for
Procurement medical devices in Finland. Also, some
Policy or guideline: No Website: — other commercial nomenclature systems
are used in healthcare organizations and
Donations comments (...Annex 1):
Policy or guideline: No Website: — —
Website: —
Density per
population

Website: —

Contacts
Name: Ms. Mari Laurén-Häussler Name: —
Email: mari.lauren-haussler@stm.fi Email: —
Name: Mrs. Ritva Bly Name: —
France

4.37 84
High
1.4%
aged 30-70 yrs from 10.60% >10% (>25%) of
(0.2%)
income (%):i
Human Development
Years

53.7 (12)
rank:f
High-technology
ICT Development
8.2 (15) exports (% of 27.00%
Index (rank):g

Website: https://solidarites-sante.gouv.fr/soins-et-maladies/autres-produits-de-sante/dispositifs-medicaux/
Ministry of health responsible for health technology policy implementation: Direction Générale de la Santé et Direction
Générale de l’Offre de Soins.

Lists available: Yes La liste des dispositifs médicaux et
prestations pris en charge par l’assurance
Unit: Ministère chargé de la santé et de la sécurité sociale. maladie est accessible à l’adresse donnée
en ameli (chercher fournisseurs-de-biens-
Website: http://www.who.int/medical_devices/survey_resources/medical_devices_for_ medicaux/exercer-au-quotidien/liste-
procurement_reimbursement_france.pdf des-produits-et-prestations-lpp/liste-des-
https://www.ameli.fr produits-et-prestations-lpp/).
Website - hospitals: http://www.ameli.fr/
Website - laboratories: https://www.ansm.sante.fr/Activites/Surveillance-du-marche-des-
dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMDIV/Dispositifs-
medicaux-de-diagnostic-in-vitro-Controles-de-lot-ponctuels-en-laboratoire/(offset)/2
Website: —
e
There are three commissions: La
HTA unit/department includes the assessment of medical devices: Yes commission de la transparence (CT); la
Unit/department: Haute Autorité de Santé. commission nationale d’évaluation des
dispositifs médicaux et des technologies
Website(s): https://www.has-sante.fr/jcms/c_2883073/fr/evaluation-des-technologies-de- de santé (CNEDIMTS), and la commission
sante-a-la-has-place-de-la-qualite-de-vie évaluation économique et de santé
https://www.has-sante.fr/jcms/c_821871/fr/securite-du-patient-guides-et-outils publique (CEESP).
https://www.has-sante.fr/jcms/c_428381/fr/accreditation-des-medecins-et-equipes-
medicales
Contact: Mr. Jean-Patrick Sales Email: jp.sales@has-sante.fr

Name of regulatory agency: Ministère du Travail, de l’Emploi et de la Santé. —
Website(s): http://www.sante.gouv.fr/
Contact: Ms. Emmanuelle Barsky– Adjointe au chef de bureau Email: emmanuelle.
barsky@sante.gouv.fr
Name(s) of other regulatory agency eg. for radiation equipment etc.: Ministère du
Travail, de l’Emploi et de la Santé.
126 Other agency’s website: https://ansm.sante.fr/; https://ec.europa.eu/jrc/en/emar/about/euratom
WHO European Region
France
For various purposes devices and Regulation (EU) 2017/746, the
Website: http://www.legifrance.gouv.fr; https://www.gmdnagency.org/ of MD representatives (of both the
Donations —
Website: https://www.ameli.fr/professionnel-de-la-lpp/exercice-professionnel/
facturation/liste-des-produits-et-prestations-lpp/liste-produits-prestations-lpp
Density per
population


Unit/Department: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS). Unit website: —
Contact name: Mr. Jean-Claude Ghislain Contact email: Jean-Claude.GHISLAIN@ansm.sante.fr
Website: —

Contacts
Name: Ms. Geraldine Bonnin Name: —
Email: Geraldine.BONNIN@sante.gouv.fr Email: —
Name: Mr. Jean-Claude Ghislain Name: —
Email: Jean-Claude.GHISLAIN@ansm.sante.fr Email: —
General comments (...Annex 1): Dans cette enquete, nous avons mentionnées la HAS et l’ANSM qui sont deux
agences qui sont chargées: HAS: Agence d’évaluation des dispositifs médicaux ANSM : Agence nationale de sécurité du
médicament qui est chargée de la sécurité sanitaire des dispositifs médicaux.
Gabon

41.73 49
Upper-Middle
aged 30-70 yrs from 21.30% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
4.1 (114) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
HTA unit/department includes the assessment of medical devices: No there is not a specific national unit per
Unit/department: — se. Currently, the HTA unit is in progress
towards the Universal Health Care (UHC)
Website(s): — country goal.

Website(s): —
128
WHO African Region
Gabon
Website: https://www.sante.gov.ma/Pages/ADM_Centrale/DMP.aspx

Procurement
Donations —
Website: —
Density per
population

Unit/Department: Direction Générale de la Planification, des Infrastructures et des Équipements. Unit website: —
Contact name: Mr. Martin Essono Contact email: martessono@yahoo.fr
Website: —

Contacts
Name: Mr. Martin Essono Name: Dr. Magaran Monzon Bagayoko
Email: martessono@yahoo.fr Email: bagayokom@who.int
Name: Mr. Martin Essono Name: Dr. Aboubacar Inoua
Email: martessono@yahoo.fr Email: inouaa@who.int
Gambia

49.37 48
Low
0.2%
aged 30-70 yrs from 21.10% >10% (>25%) of
(0.0%)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
2.6 (144) exports (% of 1.70%
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Médecines Control Agency

Unit: —
Website: —
Website: —
e
HTA activities have been identified,
HTA unit/department includes the assessment of medical devices: No but there is not a specific National unit.
Unit/department: — Currently, the HTA unit is in progress
Website(s): — country goal.

Name of regulatory agency: Médecines Control Agency —
Website(s): www.mca.gm
Other agency’s website: https://www.iaea.org/newscenter/news/iaea-advises-the-gambia-on-strengthening-regulatory-
infrastructure
130
WHO African Region
Gambia
C3D4 Official nomenclature system for medical devices: Yes Type: Based on UMDNS Use: The Medical Research Council (UK) unit
Not specified “the Gambia” (refer to specified link) uses
the UMDNS system via the ECRI Health
Website: http://www.mrc.gm/ Devices Sourcebook (ECRI website). Note
that this is not used by the Ministry of
Health.
Procurement
Donations —
Website: —
Density per
population
Radiotherapy:β 0 0

Unit/Department: Royal Victoria Teaching Hospital. Unit website: —
Contact name: Mr. Michael Gomez Contact email: michael.gomez63@yahoo.com
Type of inventories available: National inventory for medical equipment Recently inventories have been compiled
for the National Laboratory Services.
Website: — However, those for Hospital/Clinical
Use of management software: Yes Software name: AIMS Program. equipment are not available yet. The
Medical Research Council (UK) the Gambia
has a full inventory of its biomedical
equipment. It is comprised of 1,500 devices
including minor clinical equipment, high-
Number of biomedical/clinical engineers professionals in the country:γ <10 cost diagnostic and research laboratory
equipment. We use a proprietary
equipment management program from
Contacts Phoenix Data Systems Inc. called AIMS
(www.goaims.com).
Name: Mr. Andrew Demba Name: Dr. Desta Alamerew Tiruneh
Email: anthems81@yahoo.com Email: tirunehd@who.int
Name: Mr. Michael Gomez Name: —
Email: michael.gomez63@yahoo.com Email: —
General comments (...Annex 1): Concerning the Infrastructure section: the private sector section correspond
to the responses for the Medical Research Council (UK) the Gambia; Concerning HT nactional policy we provide the
following doc.: Medical Equipment and Devices Policy 2010 March.doc. Concerning Section Infrastructure: We have 3 CHU
and 1 Hôpital national.
Georgia

9.26 65
Upper-Middle
29.2%
aged 30-70 yrs from 24.90% >10% (>25%) of
(9.0%)
income (%):i
Human Development
0.81
Years

(0.72): 31.8 (63)
very high
rank:f
High-technology
ICT Development
5.8 (74) exports (% of 2.60%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Lists available: No Governmental decree #153, 2007.
Website: —
e
State Regulation Agency for Medical
HTA unit/department includes the assessment of medical devices: No Activities is in charge of HTA but not for
Unit/department: — medical devices.
Website(s): —

Name of regulatory agency: State Regulation Agency for Medical Activities, Ministry Georgian National Agency For Standards,
of Labour, Health and Social Affairs. Technical Regulations and Metrology
is responsible for standartization and
Website(s): http://rama.moh.gov.ge metrology as well as calibration and
Contact: Mr. Ivane Pockhverashvili Email: — accreditation of facilities, providing
inspection of medical devices.
Name(s) of other regulatory agency eg. for radiation equipment etc.: Georgian
National Agency For Standards, Technical Regulations and Metrology.
132
WHO European Region
Georgia
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified According to Georgian legislation, Georgia
recognizes international or national
Website: https://matsne.gov.ge/ru (according on a list of certain countries)
certficates of medical devices there.

Procurement
National level procurement: Yes Website: http://www.moh.gov.ge
Donations —
Website: —
Density per
population

Type of inventories available: National inventory only for high cost technologies Nuclear and Radiation Safety Service,
Ministry of Environment and Natural
(such as MRI, CT or PET scanners) Resources.
Website: https://www.moh.gov.ge/

Contacts
Name: Ms. Eka Paatashvili Name: Dr. Silviu Domente
Email: epaatashvili@moh.gov.ge Email: domentes@who.int
Name: Mr. Nikoloz Pruidze Name: —
Email: kokap@moh.gov.ge Email: —
Germany

3.65 86
High
1.7%
aged 30-70 yrs from 12.10% >10% (>25%) of
(0.1%)
income (%):i
Human Development
0.95
Years

(0.87): 56.5 (9)
very high
rank:f
High-technology
ICT Development
8.4 (12) exports (% of 16.50%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Unit/department: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) and
DAHTA (previous DIMDI).
Website(s): https://www.bfarm.de/DE/Home/home_node.html
https://www.dimdi.de/dynamic/de/startseite
https://www.iqwig.de/en/

Name of regulatory agency: Federal Ministry of Health (BMG) - Unit Medical There are more than 30 regional
Devices. Competent Authorities.
Website(s): http://www.bmg.bund.de
Contact: Dr. Matthias Neumann Email: matthias.neumann@bmg.bund.de
Name(s) of other regulatory agency eg. for radiation equipment etc.: Federal
Institute for Drugs and Medical Devices (BfArM); Central Authorithy of the Laender for Health Protection with Regard to
Medicinal Products and Medical devices (ZLG).
Other agency’s website: https://www.bfarm.de/EN/Home/home_node.html
https://www.bmu.de/en/; https://www.bfs.de/EN/bfs/laws-regulations/laws-regulations_node.html
134
WHO European Region
Germany
Website: http://www.dimdi.de of MD representatives (of both the
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: — Name: —
Name: — Name: —
General comments (...Annex 1): Germany does not complete the whole survey because of their federal system,
which will imply to make the whole survey in their 16 states. Regarding the Regulations section: they follow the EU system,
other matters are state´s competency.
Ghana

44.71 45
Lower-Middle
aged 30-70 yrs from 22.50% >10% (>25%) of 1.1% (0.1%)
income (%):i
Human Development
0.61
Years

(0.44): 22.3 (108)
medium
rank:f
High-technology
ICT Development
4.1 (116) exports (% of 1.10%
Index (rank):g

Website: —
Ministry of health responsible for health technology policy implementation: Clinical Engineering Department and the
Biomedical Engineering Unit.

Lists available: Yes, but it is only a recommendation The standard list serves as a guide. The
actual procurement is based on the need
Unit: Clinical Engineering Department. of health facility, availability of utilities, and
availability of professional user staff.
Website: —
Website: —
e
There are identified HTA activities but
HTA unit/department includes the assessment of medical devices: No there is not a national unit per se. HTA
Unit/department: — structures (Steering Committee, Technical
Working Group and Secretariat) in the
Website(s): — MOH have been set up and a national
Contact: — Email: — HTA strategy developed and yet to
be launched. In progress towards the
Committee includes a biomedical or clinical engineer: — Universal Health Care country goal.

Name of regulatory agency: Food and Drug Board. The Radiation Protection Institute
Website(s): https://www.fdaghana.gov.gh/ is responsible for the regulation of
equipment with radiation sources such as
Contact: Ernest Afesey Email: eafesey@yahoo.com X-Ray machines.
Protection Institute.
Other agency’s website: https://rpi.gaecgh.org/; https://gnra.org.gh/
136
WHO African Region
Ghana
Website: https://fdaghana.gov.gh/images/stories/pdfs/downloads/GUIDELINES%20
FOR%20THE%20REGISTRATION%20OF%20MEDICAL%20DEVICES-REVIEWED.pdf

Procurement Medical device incorporation
Policy or guideline: Yes Website: https://pcghana.org/
The Ghana National Procurement
National level procurement: Yes law as well as the Ministry of Health
Website: https://www.moh.gov.gh/procurement-supply/ (MoH). Depending on the value of the
procurement package, the health facilities
Donations are allowed to procure sometimes, the
Policy or guideline: Yes Website: — unit of the MoH also procures some of
the capital equipment especially from
Technical specifications other projects. All procurement of medical
devices is carried out with the technical
Technical specifications to support procurement or donations: Yes support of the Clinical Engineering
Publically available: — Department of the Ghana Health Service
or the Biomedical Engineering Unit of the
Website: — MoH.
Density per
population

Unit/Department: Biomedical Engineering Department. Unit website: https://www.moh.gov.gh/
Contact name: Dr. Nichodemus Kafui Gebe Contact email: —
Website with publically available technical specifications: https://www.fdaghana.gov.gh/img/organisation/GUIDELINE%20
FOR%20LICENSING%20OF%20PREMISES%20FOR%20MANUFACTURING%20MEDICAL%20DEVICES.pdf
Type of inventories available: National inventory only for high cost technologies Most inventories are held at a regional and
an institutional level. We are yet to acquire
(such as MRI, CT or PET scanners) the software for the management of the
Website: — inventory at the national level.

Contacts
Name: Dr. Nicholas Adjabu Name: Dr. Francis Chisaka Kasolo
Email: adjabu95@yahoo.com Email: kasolof@who.int
Name: Dr. Nichodemus Kafui Gebe Name: Ms. Edith Andrews Annan
Email: — Email: andrewsE@who.int
General comments (...Annex 1): There is no written nor published national health technology policy yet but there
are policies available that have been established by the systems and structures unit for health technology in Ghana. Ghana
Health Service has drafted its operational policy for healthcare equipment and needs to be finalized.
Greece

4.07 78
High
16.9%
aged 30-70 yrs from 12.50% >10% (>25%) of
(1.6%)
income (%):i
Human Development
0.89
Years

(0.79): 36.8 (43)
very high
rank:f
High-technology
ICT Development
7.2 (38) exports (% of 12.50%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
Various HTA institutions are performing
HTA unit/department includes the assessment of medical devices: Yes a variety of domains including medical
Unit/department: National Evaluation Center of Quality and Technology in Health devices.
(EKAPTY).
Website(s): https://www.ekapty.gr/
http://www.phs.uoa.gr/
http://www.eopyy.gov.gr
https://www.ifet.gr/en/
Contact: — Email: info@ekapty.gr

Name of regulatory agency: National Organization for Medicines. —
Website(s): www.eof.gr
Name(s) of other regulatory agency eg. for radiation equipment etc.: Greek Atomic
Energy Commission
Other agency’s website: www.eeae.gr
138
WHO European Region
Greece
Website: https://www.gmdnagency.org/ of MD representatives (of both the
Donations The EU Directive for public procurement
Policy or guideline: Yes Website: www.eof.gr and national specific legislation for health
procurement (law 3580/2007). A part
Technical specifications of procurement of medical devices is
Technical specifications to support procurement or donations: Yes carried out at a national level, by the Health
Procurement Committee.
Website: https://www.moh.gov.gr/
Density per
population

Unit/Department: Health Procurement Committee. Unit website: https://www.moh.gov.gr/articles/epitroph-promhtheiwn-ygeias
Website with publically available technical specifications: https://www.moh.gov.gr/articles/epitroph-promhtheiwn-ygeias/
diaboyleyseis-texnikwn-prodiagrafwn
Type of inventories available: National inventory only for high cost technologies “Praxis”, was developed by the Institute
of Biomedical Technology (INBIT), and it
(such as MRI, CT or PET scanners) is a specific one. Also, it is used the Asset
Website: — Management Software.
Use of management software: Yes Software name: Various such as Praxis.

Contacts
Name: Mr. Tarsi Giannouli Name: Dr. Jaana Marianna Trias
Email: tgiannouli@ekapty.gr Email: TriasJ@who.int
Name: — Name: —
Grenada

16.35 70
Upper-Middle
aged 30-70 yrs from 23.40% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
5.8 (73) exports (% of —
Index (rank):g

Website: —
Ministry of health responsible for health technology policy implementation: Administration and Biomedical Engineering
Department.

Lists available: Yes The list can be requested from the
management of the Hospital services.
Unit: — However there is no web to guideline
because was never used as a policy of the
Website: — MoH.
Lists available: No No lists available.
Website: —
e
—
Website(s): —

Website(s): —
140
Grenada
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed A system was develop but it was not
Use: For procurement purposes supported by management. There is no
URL because this software was locally
Website: — developed.

Procurement
Donations There are procurement guideliness but
Policy or guideline: No Website: — they are not implemented or followed.
The procurement of medical devices
Technical specifications are carried out at a national level by the
Technical specifications to support procurement or donations: Yes Central Medical Stores Unit (CMS). No
specific devices have been selected but
Publically available: No the needed assessment was done.
Website: —
Density per
population
Radiotherapy:β 0 0

Type of inventories available: National inventory for medical equipment The inventory for all medical equipment in
the island can be found in the Biomedical
Website: — Engineering Department, General Hospital.
Use of management software: Yes Software name: Medical device Management The system was locally developed,
installed and called The Medical Device
System Software. Management System Software.

Contacts
Name: Mr. Stephen Prince Name: Dra. Amalia Del Riego
Email: princealista@hotmail.com Email: delriegoa@paho.org
Name: — Name: Cecilia Acuña
Guatemala

23.65 57
Upper-Middle
1.4%
aged 30-70 yrs from 16.50% >10% (>25%) of
(0.0%)
income (%):i
Human Development
0.66
Years

(0.48): 22.4 (106)
medium
rank:f
High-technology
ICT Development
3.4 (125) exports (% of 4.90%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website - laboratories: https://medicamentos.mspas.gob.gt/phocadownload/Listado_de_
Formas/F-AS-o-02%20V%2005-2020%20Listado%20codificado%20grupo%20terapeutico.
pdf
Lists available: Yes Ver: Norma Técnica Vigente para
inscripción sanitaria de dispositivos
Website: https://www.mspas.gob.gt/ médicos. Específicamente la Normativa 37.
e
HTA activities have been identified,
HTA unit/department includes the assessment of medical devices: No but there is not a specific national unit.
Unit/department: Instituto Guatemalteco de Seguro Social is part of RedETSA Currently, the HTA unit is in progress
Website(s): https://sicoin.minfin.gob.gt country goal. There are the following
https://siges.minfin.gob.gt units: Planificación Estratégica (SIGSA),
Observatorio en Salud Reproductiva
Contact: Florencia Garcia Email: flor.garcia@igssgt.org (OPSOMS/OSAR) y Sistema Informático

Name of regulatory agency: Departamento de Regulación y Control de Productos —
Farmacéuticos y Afines.
Website(s): https://medicamentos.mspas.gob.gt/
Contact: Ms. Elizabeth Recinos de Posadas Email: —
Name(s) of other regulatory agency eg. for radiation equipment etc.: Ministerio de
Energía y Minas.
Other agency’s website: https://mem.gob.gt/?s=equipo+m%C3%A9dico&submit=Go
142
Guatemala
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed La Clasificación In Vivo y según Clase se
Use: Not specified encuentra contemplada en el Anexo de la
Norma Técnica No. 37.
Website: https://www.mspas.gob.gt/
https://medicamentos.mspas.gob.gt/

Procurement
National level procurement: Yes Website: https://www.guatecompras.gob.gt/
Donations The procurement is done, at general level,
Policy or guideline: Yes Website: — by the Sistema de Adquisiciones del
Estado de Guatemala.
Website: —
Density per
population

Type of inventories available: None No se utiliza ninguno.
Website: —

Contacts
Name: Ms. Elizabeth Recinos de Posadas Name: Dr. Gerardo Alfaro
Email: drcpfa.jefatura@gmail.com Email: alfaroge@paho.org
Name: Ms. Silvana Figueroa Name: Dra. Caroline Chang
Email: silufima@hotmail.com Email: changcar@paho.org
Guinea

95.56 37
Low
7.0%
aged 30-70 yrs from 24.90% >10% (>25%) of
(1.3%)
income (%):i
Human Development
Years
Index (inequality 0.48 Global innovation

17.3 (130)
adjusted HDI): (0.31): low index (rank):j
rank:f
High-technology
ICT Development
1.8 (166) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
National list for specific clinical interventions/emergencies: Les Normes ont été définies pour les
formations sanitaires de base (postes,
Lists available: — centres de santé), les Centres de santé
Website: — améliorés, les Hôpitaux préfectoraux /
districts sanitaires et les Hôpitaux
Régionaux. Ces normes ne sont pas
e
National health technology assessment unit disponibles pour toutes les unités
—
Website(s): —

Name of regulatory agency: Division Equipement et Maintenance de la DNEHS. —
Website(s): https://sante.gov.gn/
Contact: Mr. Amadou Timbi Bah Email: amadoutimbibah@yahoo.fr
144
WHO African Region
Guinea
Website: —

Procurement
Donations For procurement or donnations: nous
Policy or guideline: Yes Website: — procédons par appel d’offres national ou
international.
Website: —
Density per
population
Mammograph:α,* 0 0
Radiotherapy:β 0 0

Unit/Department: Section Equipement (SE). Unit website: —
Contact name: Mr. Mamadouba Camara Engagé Contact email: mamadoubaengage@yahoo.fr
Type of inventories available: National inventory for medical equipment L’inventaire disponible n’est pas exhaustif
en ce qui concerne tous les dispositifs
Website: — medicaux actuallement utilisés

Contacts
Name: Mr. Amadou Timbi Bah Name: Dr. Georges Alfred Ki-Zerbo
Email: amadoutimbibah@yahoo.fr Email: kizerbog@who.int
Name: Mr. Mamadouba Camara Engagé Name: —
Email: mamadoubaengage@yahoo.fr Email: —
Guinea-Bissau

76.84 37
Low
aged 30-70 yrs from 24.90% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
1.5 (173) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): —
146
WHO African Region
Guinea-Bissau
Website: —

Procurement
Donations —
Website: —
Density per
population
Mammograph:α,* 0 0
Radiotherapy:β 0 0

Type of inventories available: — Inventário Nacional de Equipamentos
Médicos: Trabalho curso e dados parciais
Website: — para o sul do País.

Contacts
Name: Mr. Fodé Carambá Sanhá Name: Dr. Georges Alfred Ki-Zerbo
Email: focasa60@gmail.com Email: kizerbog@who.int
Name: Mr. Hamilton Ferreira Name: Mr. Inácio Alvarenga
Email: hamiltonpnds@yahoo.es Email: alvarengai@who.int
Guyana

28.4 74
Upper-Middle
aged 30-70 yrs from 29.20% >10% (>25%) of — (—)
income (%):i
Human Development
0.68
Years

(0.56): — (—)
medium
rank:f
High-technology
ICT Development
3.4 (124) exports (% of 0.10%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): —
148
Guyana
Website: https://gafdd.gy/inspectorate/#

Procurement
Donations —
Website: —
Density per
population

Unit/Department: Regional Radiology. Unit website: —
Contact name: Ms. Donna Bowman Contact email: dasbowman@yahoo.co.uk
Type of inventories available: National functional inventory for medical equipment There are inventories for X-ray equipment.
One public corporation uses an assets
Website: — software to carry out the same function.

Contacts
Name: Ms. Donna Bowman Name: Dr. Luis Felipe Codina
Email: dasbowman@yahoo.co.uk Email: codinalu2@paho.org
Name: Ms. Donna Bowman Name: Dr. Daniel Albretch
Email: dasbowman@yahoo.co.uk Email: albrechdan@paho.org
Haïti

60.48 47
Lower-Middle
11.5%
aged 30-70 yrs from 31.30% >10% (>25%) of
(4.0%)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
1.7 (168) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): —
150
Haïti
Website: —

Procurement
Donations —
Website: —
Density per
population


Type of inventories available: — Il n’existe pas encore une liste d’inventaire
technique national pour les equipements
Website: — medicaux.
Use of management software: Yes Software name: GMAO.

Contacts
Name: Mr. Roland Palme Name: Dr. Maureen Birmingham
Email: palmeroland@hotmail.com Email: birminghamm@paho.org
Name: Dr. Duperval Mona Name: Dr. Pedro Lopez
Email: Mspp_doss@yahoo.fr Email: lopezped@paho.org
General comments (...Annex 1): Concerning the Infrastructure section: les centres de santé sont dotés de 10 lits.
Honduras

16.22 63
Lower-Middle
aged 30-70 yrs from 18.70% >10% (>25%) of — (—)
income (%):i
Human Development
0.63
Years

(0.47): 23 (103)
medium
rank:f
High-technology
ICT Development
3.3 (129) exports (% of 2.00%
Index (rank):g

Website: http://www.salud.gob.hn/
Ministry of health responsible for health technology policy implementation: Agencia Regulatoria Sanitaria de Honduras.

Unit: —
Website: —
Website: —
e
Website(s): —

Name of regulatory agency: Agencia Regulatoria Sanitaria de Honduras (ARSA). —
Website(s): https://www.arsa.gob.hn/index.php?page=dm&num=2
Contact: Dr. Francis Contreras Email: —
Name(s) of other regulatory agency eg. for radiation equipment etc.: Secretaría de
Recursos Naturales y Ambiente (MiAmbiente+)
Other agency’s website: http://www.miambiente.gob.hn/
https://www.ccichonduras.org/website/Descargas/LEYES/LEGISLACION_AMBIENTAL/REGLAMENTO_DE_PROTECCION_
RADIOLOGICA.pdf
152
Honduras
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed El Reglamento para el Control Sanitario de
Use: For various purposes Productos, Servicios y Establecimientos
de Interés Sanitario, establece una
Website: http://www.salud.gob.hn/site/ nomenclatura con fines de Registro.
Medical device incorporation Medical device incorporation

Procurement comments (...Annex 1):
Policy or guideline: Yes Website: http://www.honducompras.gob.hn Ley de Contratación del Estado y
Reglamento de Ley de Contratación del
National level procurement: Yes Website: https://www.honducompras.gob.hn/ Estado (more information under https://
Donations www.arsa.gob.hn/ ). Cada uno de
los Programas de Salud dependientes
Policy or guideline: Yes Website: https://www.arsa.gob.hn/ de la Dirección antes mencionada o
entes cooperantes realizan compras de
Technical specifications dispositivos médicos para proveer a nivel
Technical specifications to support procurement or donations: No nacional, como pueden ser pruebas de
laboratorio y anticonceptivos. El Programa
Publically available: — de Equipamiento se elabora por demanda
Website: — y por complejidad.
Density per
population

Unit/Department: Programa de Equipamiento. Dirección General de Sistemas y Servicios de Salud. Unit website: —
Contact name: Ms. Rosa María Rivas Contact email: roma_ribu@yahoo.com
Type of inventories available: National inventory for medical equipment El inventario es por Objeto de Gasto. Existe
el SIAFI que es un sistema informático para
Website: — fines de presupuesto, el cual actualmente
Use of management software: Yes Software name: SIAFI. se encuentra en proceso de ampliación ya
que permitirá la gestión del equipamiento
en todas sus fases.
Contacts
Name: Dr. Francis Contreras Name: MSc. Piedad Huerta Arneros
Email: franciscontreras@arsa.gob.hn Email: huertapi@paho.org
Name: Ms. Ritza Lizardo Name: Dra. Ana Gabriela Ramirez
Email: — Email: ramirezana@paho.org
Hungary

4.05 73
High
7.4%
aged 30-70 yrs from 22.10% >10% (>25%) of
(0.3%)
income (%):i
Human Development
0.85
Years

(0.79): 41.5 (35)
very high
rank:f
High-technology
ICT Development
6.9 (48) exports (% of 17.50%
Index (rank):g

Website: https://ogyei.gov.hu/laws_and_regulations
Language(s): Hungarian

Unit: National Health Insurance Fund / Central Services Directorate General of the
Prime Minister’s Office, respectively.
Website: —
Website - hospitals: https://ec.europa.eu/growth/tools-databases/tris/en/
search/?trisaction=search.detail&year=2020&num=559
Website - laboratories: https://www.tuv.com/hungary/en/in-vitro-diagnostic-medical- Specific lists comments (...Annex 1):
device-regulation-(ivdr).html The uploaded Ministerial Decree lays
Nomenclature systems used for devices and tests: — down the minimum requirements for
the provision of healthcare services. The
National list for specific clinical interventions/emergencies: criteria are equally specified for healthcare
facilities (1.2.1) and specific procedures. The
Lists available: Yes document has been uploaded only once.
Website: https://ec.europa.eu/growth/tools-databases/tris/en/search/?trisaction=search. The decree is only available in Hungarian.
The assigned URLs contain protocols
detail&year=2020&num=559 for pandemic situation according to the
National Influenza Pandemic Preparedness
e
There are HTA activities for health
HTA unit/department includes the assessment of medical devices: Yes products, rarely for medical devices.
Unit/department: National Institute for Strategic Health Research - Office of Health
Technology Assessment.
Website(s): https://ogyei.gov.hu/health_technology_assessment/
https://ogyei.gov.hu/what_we_do_
http://semmelweis.hu/emk/en/
Contact: Dr. Marta Pekli Email: pekli.marta@eski.hu

Name of regulatory agency: Office of Health Authorisation and Administrative —
Procedures - Authority for Medical Devices.
Website(s): —
Contact: Mr. György Ferenc Balazs Email: balazs.gyorgy@eekh.hu
Name(s) of other regulatory agency eg. for radiation equipment etc.: Department
for Medical Devices, National Institute of Pharmacy.
154 Other agency’s website: http://ogyei.gov.hu/presidency2011/about_department_for_medical_deviceseekh
WHO European Region
Hungary
Policy or guideline: Yes Website: http://net.jogtar.hu/jr/gen/hjegy_doc.
cgi?docid=99300009.NM Medical device incorporation
National level procurement: Yes Website: http://www.oep.hu
For procurement guidelines see the
Donations “Decree of the Minister of Welfare” (No.
9/1993 NM) on the specific aspects of the
Policy or guideline: No Website: — financing of healthcare insurance services.
Technical specifications In respect of certain medical devices
procured at a national level over a certain
Technical specifications to support procurement or donations: No amount, procurement is carried out by the
Publically available: — Central Services Directorate General of the
Prime Minister’s Office. In the remaining
Website: — cases, hospitals procure medical devices
subject to itemized accounting individually
and the National Health Insurance fund
Density per
Medical equipment
reimburses a certain level of the costs
Total 1,000,000 (see the list in the corresponding website,
population but with exception of pacemakers, heart
valves, cochlear implants).

Type of inventories available: National inventory only for high cost technologies Under high-cost (amounts exceeding EUR
400). Unfortunately, the real state is not
(such as MRI, CT or PET scanners) a public registry. The access is ensured
Website: https://ogyei.gov.hu/main_page/ only for data providers, manufacturers
and conformity assessment bodies. Most
Use of management software: Yes Software name: CT-EcoSTAT. of the public institutions use the software
CT-EcoSTAT.

Contacts
Name: — Name: Dr. Ledia Lazeri
Email: — Email: lazeril@who.int
Name: — Name: —
Email: — Email: pusztaiz@who.int
General comments (...Annex 1): Concerning the HT policies: “Safety and Partnership Program” -the health
program adopted by the Hungarian government on July 9th, 2008 - the acceptance of medical devices and health
technologies into the social insurance scheme was defined in the context of improvement of insurance tasks until 2010.
Concerning the HT units section: it has been listed units that are subordinated bodies but not within the Ministry of
Iceland

1.93 87
High
aged 30-70 yrs from 8.70% >10% (>25%) of — (—)
income (%):i
Human Development
0.95
Years

(0.89): 49.2 (21)
very high
rank:f
High-technology
ICT Development
9 (1) exports (% of 38.10%
Index (rank):g

Website: —
Language(s): —

Lists available: No Only CE marked medical devices are
approved.
Unit: —
Website: —
Website: —
e
—
Website(s): —

Name of regulatory agency: Directorate of Health. According to Directives 93/42, 90/385 and
Website(s): http://www.landlaeknir.is/ 98/79.
Contact: Ms. Anna Björg Aradóttir Email: annabara@landlaeknir.is
Name(s) of other regulatory agency eg. for radiation equipment etc.: The
Directorate of Health is the Competent Authority for Medical Devices.
Other agency’s website: https://www.ima.is/medical_devices
156
WHO European Region
Iceland
Website: https://www.ima.is/medical_devices/about_medical_devices/

Procurement
Donations —
Website: —
Density per
population

Website: —

Contacts
Name: Mrs. Áslaug Einarsdóttir Name: —
Email: aslaug.einarsdottir@hbr.stjr.is Email: —
Name: — Name: —
India

Population 000s (rank):a 1,380,004 (2) Under-five mortality UHC - Service coverage
32.63 61
Lower-Middle
17.3%
aged 30-70 yrs from 21.90% >10% (>25%) of
(3.9%)
income (%):i
Human Development
0.65
Years

(0.48): 35.6 (48)
medium
rank:f
High-technology
ICT Development
3 (134) exports (% of 10.30%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
HTAIN performs the evaluation and
HTA unit/department includes the assessment of medical devices: Yes appropriateness and the cost-effectiveness
Unit/department: Department of Health Research (MoH). of the available and new health
technologies. It includes interventions,
Website(s): https://htain.icmr.org.in/ drugs, and medical equipment. It has
https://nhsrcindia.org/hc-technology 12 research regional hubs and several
technical partners around the country.
Contact: — Email: htain-dhr@nic.in

Name of regulatory agency: Central Drugs Standard Control Organization. Notified medical devices are regulated
Website(s): https://cdsco.gov.in/opencms/opencms/en/Home/ under the Drugs and Cosmetics Act and
Rules under the 14 rule of medical devices
Contact: Dr. V. G. Somani Email: dci@nb.nic.in as notified under the corresponding Act.
Name(s) of other regulatory agency eg. for radiation equipment etc.: Atomic
Energy Regulatory Board (AERB)
Other agency’s website: https://www.aerb.gov.in/english/
158
India
Website: —

Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: — Name: Dr. Roderico Ofrin
Email: — Email: ofrinr@who.int
Name: — Name: —
Indonesia

23 59
Lower-Middle
2.7%
aged 30-70 yrs from 24.80% >10% (>25%) of
(0.5%)
income (%):i
Human Development
0.72
Years

(0.59): 26.5 (85)
high
rank:f
High-technology
ICT Development
4.3 (111) exports (% of 7.60%
Index (rank):g

Website: —
Language(s): Indonesian
Ministry of health responsible for health technology policy implementation: a) Directorate of Production and Distribution
of Medical Devices (DG of Pharma. and Med.Dev., MoH); b) Directorate of Basic Medical Services (DG of Medical Services,
MoH).

Unit: —
Website: —
Lists available: — We do not have lists for different
diseases/situations, but we use WHO
Website: — recommendations.
e
HTA unit/department includes the assessment of medical devices: Yes of HTA systems by establishing nodal
Unit/department: Directorate of Basic Medical Services (DG of Medical Services, agencies and conducting ad-hoc activities.
Social Security Management Agency for
MoH). the Health Sector (BPJS) is focus on HTA
Website(s): https://www.bpjsketenagakerjaan.go.id for health products. Komite Penilaian
Teknologi Kesehatan (Komite PTK)
Contact: Dr. Anwarul Amin Email: hta_indonesia@yahoo.com performs economic HTA (not for medical
Committee includes a biomedical or clinical engineer: — equipment). HTA for medical equipment is
rarely performed.

Name of regulatory agency: Ministry of health. —
Website(s): https://www.kemkes.go.id/index.php?lg=LN02
Contact: Ir Rosadi Email: —
Nuclear Energy Agency of Indonesia.
Other agency’s website: http://www.batan.go.id/index.php/en/
160
Indonesia
C3D4 Official nomenclature system for medical devices: Yes It is used a Harmonization System code
Type: More than one system Use: Not specified (HS) at the moment. After harmonization
GMDN will be used.
Website: —

Procurement
National level procurement: Yes Website: https://www.kemkes.go.id/index.php?lg=LN02
Donations We follow the Presidential Decree No.
Policy or guideline: Yes Website: — 80 for general procurement. Both, yes
and no. Yes, for vertical public hospitals,
Technical specifications procurement conducted at national level.
Technical specifications to support procurement or donations: — No, since re-centralization, procurement
of medical devices at province/district’s
Publically available: — hospital conducted at local level (province
and district level); see yanmed on the
Website: — website.
Density per
population

Type of inventories available: None Inventories are still ongoing.
Website: —

Contacts
Name: Dr. T. Bahdar Johan Hamid Name: Dr. Navaratnasamy Paranietharan
Email: bahdar2007@yahoo.com Email: paranietharann@who.int
Name: — Name: —
Iran (Islamic Republic of)

12.94 77
Lower-Middle
15.8%
aged 30-70 yrs from 14.80% >10% (>25%) of
(3.8%)
income (%):i
Human Development
0.78
Years

(0.69): 30.9 (67)
high
rank:f
High-technology
ICT Development
5.6 (81) exports (% of 0.80%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
The HTA office under the umbrella of
HTA unit/department includes the assessment of medical devices: Yes the Ministry of Health and Education
Unit/department: HTA Office under supervision of Health Technology Assessment, (MOHME) was established in 2008, it
produces HTA over health products and
Standardization and Tariffs Office (MOHME’s HTA Office). medical equipment.
Website(s): —

Name of regulatory agency: Food and Drug Administration of Iran. —
Website(s): http://www.fda.gov.ir/
Energy Organization of Iran (AEOI).
Other agency’s website: www.aeoi.org.ir
http://dotic.ir/
162

Website: —

Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: — Name: Dr. Syed Jaffar Hussain
Email: — Email: hussains@who.int
Name: — Name: —
Iraq

25.24 55
Upper-Middle
3.3%
aged 30-70 yrs from 23.60% >10% (>25%) of
(0.4%)
income (%):i
Human Development
0.67
Years

(0.54): — (—)
medium
rank:f
High-technology
ICT Development
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Department of Medical Equipment within the
Directorate of Technical Affairs (MoH).

Lists available: Yes, but it is only a recommendation The lists of medical equipments have been
announced on annual basis.
Unit: Technical Affairs (Department of Medical Equipment Management and Needs
Assessment).
Website: —
Website - hospitals: https://2016.export.gov/industry/health/healthcareresourceguide/
eg_main_116238.asp
Website: —
e
It has been adopted the EMA (European
HTA unit/department includes the assessment of medical devices: No Medicines Agency) and the ICH
Unit/department: — (International Council for Harmonisation
for Pharmaceuticals) guidelines. Inspector
Website(s): — General Office performs health economics
Contact: Dr. Iman M. Hussein Email: consultivedep@yahoo.com HTA. Within the MoH, HTA is focused on
pharmaceutics not in medical devices.

Name of regulatory agency: The State Company for Provision of Medicines and The company KIMADIA is responsible for
Medical Appliances (KIMADIA). the bulk purchase of medicines, drugs,
medical supplies and equipment for whole
Website(s): https://kimadia.iq/en Iraq on behalf of the MoH. The regulations
Contact: — Email: — are pertaining to the procurement aspects.
Name(s) of other regulatory agency eg. for radiation equipment etc.: This Company
(KIMADIA).
Other agency’s website: https://rpc.gov.iq/
164
Iraq
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified The MoH is working on adapting a national
nomenclature system and linking it to the
Website: https://kimadia.iq/en UMDNS.

Policy or guideline: Yes Website: — The company provides storage,
National level procurement: Yes Website: https://kimadia.iq/en distribution and marketing of medicines
and supplies for all Iraq where it is the sole
Donations importer of the public sector as well as
developing the basic rules for setting the
Policy or guideline: No Website: — prices for each class of drugs, chemicals
Technical specifications and medical supplies to ensure the right
price to the citizens and pharmacies and
Technical specifications to support procurement or donations: Yes the relevant authorities. Works as well as
Publically available: No the allocation of quantities of medicine
(drugs and emergency life-saving
Website: — drugs) as well as the necessary supplies
to be used in exceptional emergency
circumstances. In addition, to cover part
Density per
Medical equipment
of the needs of the health institutions of
Total 1,000,000 medicine and supplies is through national
population production.

Unit/Department: State Company for Provision of Medicines and Medical Appliances (KIMADIA). Unit website: —
Contact name: Eng. Kadhim D. Sharz Contact email: kimadia_engineering@yahoo.com
Type of inventories available: National inventory for medical equipment The Ministry of Health at a central level
keeps updated records on monthly basis
Website: — for the functional status of the high-cost
Use of management software: Yes Software name: MS Excel. technologies. 2- World Health Organization
is supporting the procurement of 3 CMMS
(from GE - Asset Plus) for three Central
Maintenance Repair shops in Baghdad,
Erbil and AL-Muthanna Provinces. 3-
Number of biomedical/clinical engineers professionals in the country:γ — The Inventories for 6 provinces out of
18 are completed and 6 provinces will
be supported to carry out a functional
Contacts inventory for their medical equipment
during the current biennium 2010/11.
Name: — Name: Dr. Ahmed Zouiten
Email: — Email: zouitena@who.int
Name: Eng. Kadhim D. Sharz Name: Dr. Ezechiel Bisalinkumi
Email: kimadia_engineering@yahoo.com Email: bisalinkumie@irq.emro.who.int
General comments (...Annex 1): Data were obtained from the annual report from 2010, issued by the Department
of Planning and Human Resource Development at the MoH Iraq.
Ireland

3.02 83
High
6.4%
aged 30-70 yrs from 9.70% >10% (>25%) of
(0.7%)
income (%):i
Human Development
0.96
Years

(0.89): 53 (15)
very high
rank:f
High-technology
ICT Development
8 (20) exports (% of 26.00%
Index (rank):g

Website: https://www.hse.ie/eng/services/publications/corporate/medicaldevicesequipment.pdf
Language(s): —
Ministry of health responsible for health technology policy implementation: This is a policy of the Health Service Executive
(HSE).

Lists available: n/a. There are also several National Framework
Agreement contracts for the supply of
Unit: — medical devices and equipment. List of
reimbursable devices from Primary Care
Website: www.pcrs.ie Reimbursement Service (PCRS). List
Nomenclature systems used for devices and tests: — of reimbursable devices from PCRS is
available at pcrs website under -> online
National list for different types of healthcare facilities services -> list of reimbursable items.
(hospitals, laboratories, etc)
Health care facilities lists comments
Lists available: n/a
(...Annex 1):
Website - hospitals: n/a —
Website - laboratories: n/a
Nomenclature systems used for devices and tests: EMDN.
Website: —
e
—
Unit/department: The National Patient Safety Office, Department of Health.
Website(s): https://www.hiqa.ie/areas-we-work/health-technology-assessment
http://www.ncpe.ie
Contact: Dr. Laura Dooley Email: laura_dooley@health.gov.ie
Committee includes a biomedical or clinical engineer: No

Name of regulatory agency: Health Products Regulatory Authority (HPRA). —
Website(s): https://www.hpra.ie/
http://www.imb.ie
Contact: — Email: devices@hpra.ie
Name(s) of other regulatory agency eg. for radiation equipment etc.: Ireland’s
Health Services (HSE.ie) (Radiation Protection); Enviromental Protection Agency (Radiation).
Other agency’s website: https://www.hse.ie/eng/about/who/acute-hospitals-division/radiation-protection/
http://www.epa.ie/radiation/regulation/rpa/
166
WHO European Region
Ireland
Website: http://www.hpra.ie/homepage/medical-devices/medical-devices-information of MD representatives (of both the
Policy or guideline: Yes Website: https://www.hse.ie/eng/about/who/
healthbusinessservices/procurement/ Medical device incorporation
http://www.hse.ie/eng/ comments (...Annex 1):
Portfolio & Category Management
National level procurement: Yes Website: Health Service Executive (HSE) approach involves the development of
https://www.hse.ie/eng/about/who/healthbusinessservices/procurement/ medical devices/equipment procurement
https://www.hse.ie/eng/ strategies at a national level and the
facilitation of regional and local decision
Donations making consistent with these strategies
Policy or guideline: Yes Website: http://www.hse.ie and accompanying procedures. Go to
the website and search for: services/
Technical specifications Publications/corporate/procurementpolicy.
pdf. Health Service Executive (HSE).
Website: —
Density per
population

Unit/Department: Health Service Executive (HSE): Corporate Estates. Unit website: —
Contact name: Mr. Ger Flynn Contact email: ger.flynn@hse.ie
Website with publically available technical specifications: n/a
Type of inventories available: — There are no national inventories available
to date. Inventories of medical equipment
Website: — (including functional inventories) are
Use of management software: Yes Software name: No common software but a maintained at a local level. Often there are
separate asset management and medical
variery of systems including: HEX, SAP, MS Access,... equipment management inventories. There
is an initiative to compile this data into
Medical devices workforce regional/national inventories in the near
future. There is no common software but a
Number of biomedical/clinical engineers professionals in the country:γ 330 variety of systems are employed including
HEX, SAP, MS Access.
Contacts
Name: Dr. Karen McNamara Name: —
Email: Legislation_Units@health.gov.ie Email: —
Name: Mr. Ger Flynn - National Clinical Head of Medical Name: —
Devices, HSE
Email: —
Email: —
General comments (...Annex 1): Concerning the Infrastructure section: the breakdown of infrastructures does not
match to our public sector. We have 7 Hospital Groups.
Israel

3.58 84
High
6.7%
aged 30-70 yrs from 8.80% >10% (>25%) of
(1.0%)
income (%):i
Human Development
0.92
Years

(0.81): 53.5 (13)
very high
rank:f
High-technology
ICT Development
7.9 (23) exports (% of 23.10%
Index (rank):g

Website: —
Language(s): Hebrew
Ministry of health responsible for health technology policy implementation: Medical Device Deparment within the Medical
Techology Administration.

Lists available: Yes List for procurement/reimbursement It is
part of the National Insurance Law.
Unit: Medical Technology Administration.
Website: —
Lists available: Yes It is in the Israeli legislation.
Website: —
e
The HTA within the MoH, as well as
HTA unit/department includes the assessment of medical devices: Yes research centers such as the Israeli Center
Unit/department: Medical Devices Department and Medical Technology Division. for Technology Assessment in Health Care
(ICTAHC).
Website(s): https://www.health.gov.il/English/MinistryUnits/HealthDivision/
MedicalTechnologies/MTPD/Pages/default.aspx
http://www.gertnerinst.org.il/e/health_policy_e/technology
Contact: Dr. Nadav Sheffer Email: nadav.sheffer@moh.health.gov.il

Name of regulatory agency: Medical Device Department. Contact person: Avi Kravel within the
Website(s): https://www.health.gov.il/English/MinistryUnits/HealthDivision/ Medical Devices department.
MedicalTechnologies/MLD/Pages/default.aspx
Contact: Mr. Nadav Sheffer Email: Nadav.sheffer@moh.health.gov.il
Name(s) of other regulatory agency eg. for radiation equipment etc.: Soreq Nuclear
Research Center (SNRC).
Other agency’s website: http://soreq.gov.il/mmg/eng/Pages/Radiation-Safety.aspx
168
WHO European Region
Israel
Not specified
Website: https://www.health.gov.il/English/MinistryUnits/HealthDivision/
MedicalTechnologies/MLD/Pages/default.aspx

Procurement
Donations Technical specifications are available only
Policy or guideline: No Website: — in hardcopy.
Website: —
Density per
population

Unit/Department: Medical Technology Administration. Unit website: —
Contact name: Mr. Liron Zohar Contact email: liron.zohar@moh.health.gov.il
Website: —
Use of management software: Yes Software name: Locally developed.

Contacts
Name: Dr. Nadav Sheffer Name: —
Email: Nadav.sheffer@moh.health.gov.il Email: —
Name: Mr. Liron Zohar Name: —
Email: liron.zohar@moh.health.gov.il Email: —
General comments (...Annex 1): All the divisions and departments mentioned in this survey are part of the
Medical Technology Administration of the Ministry of Health in Israel. The Administration is in charge of the regulation,
licencing and policy making regarding all medical technologies in Israel (including medical devices).
Italy

2.91 83
High
9.3%
aged 30-70 yrs from 9.00% >10% (>25%) of
(1.1%)
income (%):i
Human Development
0.89
Years

(0.78): 45.7 (28)
very high
rank:f
High-technology
ICT Development
7 (47) exports (% of 8.10%
Index (rank):g

Website: http://www.salute.gov.it/portale/home.html
Language(s): Italian and English
Ministry of health responsible for health technology policy implementation: Directorate General of Medicines and Medical
Devices, Department of Innovation, Ministry of Health.

Lists available: Yes Documents are available at the websites.
Documents are often updated, and many
Unit: Diretorate General of Health Programme. of them under revision.
Website: http://www.who.int/medical_devices/survey_resources/medical_devices_for_
procurement_reimbursement_italy_3.pdf; https://www.salute.gov.it/portale/home.html
Website - laboratories: http://www.dati.salute.gov.it/dati/dettaglioDataset.
jsp?menu=dati&idPag=1
Website: —
e
Agenzia Nazionale per i Servizi
HTA unit/department includes the assessment of medical devices: Yes Sanitari Regionali (AGENAS) performs
Unit/department: Directorate General for Medical Devices. HTA for medical devices, and Italian
medicines agency (AIFA) mainly in
Website(s): http://www.agenas.it pharmaceutics and related. HTA is also
https://www.aifa.gov.it/en/web/guest/home performed in research institutes such as
http://www.sanita.padova.it PoliclinicoGemelli (last link).
http://www.salute.gov.it/portale/temi/p2_5.jsp?lingua=italiano&area=dispositivi-
medici&menu=tecnologie; https://www.policlinicogemelli.it/en/
Contact: Dr. Giuseppe Ruocco Email: g.ruocco@sanita.it

Name of regulatory agency: Directorate General for Medical Devices, Addresse and contact of the Medical
Pharmaceutical Services and Safety in Healthcare, Department of Planning and Devices Directorate: Via Molise 2, 00187
Organization of the National Health Service, Ministry of Health. Roma, Italy. Tel. +390647051.
Website(s): http://www.salute.gov.it/portale/home.html
Contact: Ms. Marcella Marletta Email: m.marletta@sanita.it
Name(s) of other regulatory agency eg. for radiation equipment etc.: Italian National Agency for New Technologies,
Energy and Sustainable Economic Development (IMRI); National Inspectorate for Nuclear Safety and Radiation Protection
(ISIN). Other agency’s website: https://www.inmri.enea.it/
170 https://www.isinucleare.it/en/about-us
WHO European Region
Italy
C3D4 Official nomenclature system for medical devices: Yes Type: Based on EMDN Use: CND Classificazione Nazionale dei
For various purposes Dispositivi Medici (correlated with GMDN).
CND was nationally developped, and
Website: http://www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_15_file. it is the base for EMDN. As mentioned
pdf on several occasions in the past, a
map of correspondence between the
http://www.salute.gov.it/portale/temi/p2_3_dispositivi.html GMDN nomenclature and the Italian
CND classification has been created
since 2007 to allow manufacturers
to register in the Italian database of
medical devices. This map is subject to
Procurement
Policy or guideline: Yes Website: http://www.salute.gov.it/portale/home.html
National level procurement: No Website: http://www.salute.gov.it/
Donations Go to the website and look for: dispositivi/
Policy or guideline: No Website: — dispomed.jsp documents.
Website: http://www.who.int/medical_devices/survey_resources/medical_device_
technical_specifications_italy_1.pdf
http://www.who.int/medical_devices/survey_resources/medical_device_technical_specifications_italy_2.pdf
Density per
population


Unit/Department: Directorate General for Medical Devices. Unit website: http://www.salute.gov.it/portale/home.html
Contact name: Mr. Giuseppe Ruocco Contact email: g.ruocco@sanita.it
Website with publically available technical specifications: http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=89&a
rea=dispositivi-medici&menu=caratteristichegenerali
http://www.salute.gov.it/imgs/C_17_pubblicazioni_1238_allegato.pdf
Website: —
Use of management software: Yes Software name: More than one.

Contacts
Name: Dr. Giuseppe Ruocco Name: —
Email: g.ruocco@sanita.it Email: —
Name: — Name: —
Jamaica

13.28 70
Upper-Middle
aged 30-70 yrs from 16.90% >10% (>25%) of — (—)
income (%):i
Human Development
0.73
Years

(0.61): 29.1 (72)
high
rank:f
High-technology
ICT Development
4.8 (98) exports (% of 3.10%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Lists available: No Not available at present.
Website: —
e
At the moment, the country does not have
HTA unit/department includes the assessment of medical devices: No an official process for collecting evidence
Unit/department: — and preparing HTA reports as an input
for making health coverage decisions, but
Website(s): https://www.moh.gov.jm/ they are interested in working towards it.

Website(s): —
Name(s) of other regulatory agency eg. for radiation equipment etc.: Hazardous
Substances Regulatory Authority (HSRA), Caribbean Community, International
Atomic Energy Agency.
Other agency’s website: https://www.miic.gov.jm/content/hazardous-substances-regulatory-authority-hsra
172
Jamaica
Website: https://www.moh.gov.jm/divisions-agencies/divisions/standards-and-regulation-
division/guidelines-forms-lists/

Procurement
Donations The procurement is done at regional and
Policy or guideline: No Website: — hospital levels.
Website: —
Density per
population

Website: —

Contacts
Name: Mr. Garfield Prescod Name: Mr. Ian Stein
Email: gmprescod@yahoo.com Email: steinian@paho.org
Name: Mr. Marlon Jones Name: Dr. Casimiro Canha
Email: marloncurtis@hotmail.com Email: canhaccas@paho.org
General comments (...Annex 1): Concerning the HT national policy is stated in the document Ritza 04.
Japan

2.49 85
High
4.4%
aged 30-70 yrs from 8.30% >10% (>25%) of
(0.6%)
income (%):i
Human Development
0.92
Years

(0.84): 52.7 (16)
very high
rank:f
High-technology
ICT Development
8.4 (10) exports (% of 17.00%
Index (rank):g

Website: —
Language(s): Japanese
Ministry of health responsible for health technology policy implementation: Economic Affairs Division, Health Policy
Bureau.

Lists available: Yes New medical devices which begin to be
reimbursed have been published by the
Unit: Medical Economics Division, Health Insurance Bureau. Central Social Insurance Medical Council.
Website: —
Website: —
e
There are a medical technology evaluation
HTA unit/department includes the assessment of medical devices: Yes team, an expert committee for insurance
Unit/department: Medical Device Evaluation Division, PSEHB, MHLW care materials, an expert committee on
drug prices (within the MoH: first link).
Website(s): https://www.mhlw.go.jp/english/ Also, the National Institute of Public Health
Contact: — Email: — performs economic health evaluation
(second link).

Name of regulatory agency: Compliance and Narcotics Division, PSEHB, MHLW —
Website(s): https://www.mhlw.go.jp/index.html
Regulation Authority (NRA JAPAN); Ministry of Economy, Trade and Industry
(METI).
Other agency’s website: https://www.nsr.go.jp/english/; www.meti.go.jp › english
174
Japan
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: Japanese Medical Device Nomenclature
For regulatory purposes was developed from the GMDN 2003
version.
Website: https://www.std.pmda.go.jp/stdDB/index_en.html

Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: — Name: —
Name: — Name: —
Jordan

15.02 60
Upper-Middle
aged 30-70 yrs from 15.30% >10% (>25%) of — (—)
income (%):i
Human Development
0.73
Years

(0.62): 27.8 (81)
high
rank:f
High-technology
ICT Development
6 (70) exports (% of 1.40%
Index (rank):g

Website: http://www.moh.gov.jo
Ministry of health responsible for health technology policy implementation: Directorat of Biomedical Engineering.

Lists available: Yes The list is not published. It is within
the updated document of the study
Unit: Directorate of Biomedical Engineering / Department of Studies & Projects. department.
Website: http://dbe.gov.jo/
Nomenclature systems used for devices and tests: UMDNS.
Nomenclature systems used for devices and tests: UMDNS.
Lists available: Yes We have a list but for a specific
departments, it is not published. It is only
Website: — updated and kept in the Study & Project
Department. In the near future it will be
published the Essential list at our website.
e
Structured HTA capacity_building is
HTA unit/department includes the assessment of medical devices: Yes being developed and implemented
Unit/department: Directorate of Biomedical Engineering and the Study & Projects in the Department of the Pharmacy
Center for Drug Policy and Technology
Department. Assessment (CDPTA), King Hussein
Website(s): http://dbe.gov.jo/ Cancer Center (third link). Jordan started
http://hhc.gov.jo/ a hospital-level HTA at King Hussein
Cancer Center (KHCC). The CDPTA at
https://www.khcc.jo/en KHCC is responsible for conducting
http://www.moh.gov.jo/Pages/viewpage.aspx?pageID=168 HTAs, their assessments are appraised
by the Pharmacy and Therapeutic (P&T)
Contact: Eng. Mais Bny Sakher Email: mais.banysakher@yahoo.com Committee and HTA results are currently
Committee includes a biomedical or clinical engineer: Yes utilized to support formulary listing
decisions.

Name of regulatory agency: Jordan Food & Drug Adminstration. It also exists the Energy & Minerals
Website(s): http://www.jfda.jo/ Regulatory Commission.
Contact: Dr. Mai Masadeh Email: mai.masadeh@jfda.jo
Name(s) of other regulatory agency eg. for radiation equipment etc.: Jordan Atomic
Energy Commission
Other agency’s website: https://www.emrc.gov.jo/
176
Jordan
C3D4 Official nomenclature system for medical devices: Yes This country will support the WHO
Type: More than one system Use: For various purposes standard nomenclature for medical
devices. Until now, its nomenclature is
Website: http://www.jfda.jo/Default.aspx based on UMDNS for management in
the CMMS system, and the government
procurement department uses UNSPSC
Medical device incorporation nomenclature for procurement purposes.
Procurement
Policy or guideline: Yes Website: http://dbe.gov.jo
http://gsd.gov.jo Medical device incorporation
National level procurement: Yes Website: http://gsd.gov.jo
The procurement is done at a national level
Donations by Ministry of Health. Some manufacturers
have guidelines and technical specificatios
Policy or guideline: No Website: — such as: ECRI, AAMI, HTM (See: http://
Technical specifications dbe.gov.jo). Although the list is not
published neither available online, it’s
Technical specifications to support procurement or donations: Yes within the updated document of the study
Publically available: No department.
Website: http://dbe.gov.jo
Density per
population

Unit/Department: Directorat of Biomedical Engineering. Unit website: http://dbe.gov.jo
Contact name: Dr. Eng. Firas Abu Dalou Contact email: dfiras70@yahoo.com
Website with publically available technical specifications: http://dbe.gov.jo/Pages/viewpage?pageID=61
Website: —
Use of management software: Yes Software name: CMMS.

Contacts
Name: Dr. Firas Abu Dalou Name: Dr. Jamela Saleh Mohamed Al-Raiby
Email: dfiras70@yahoo.com Email: alraibyj@who.int
Name: — Name: Dr. Adi Nuseirat
Email: — Email: nuseirata@who.int
General comments (...Annex 1): Concerning medical equipment management section: we have around 700 type
medical equipment tech., spec., updated only in tenders are published; and we have 30 medical equipment, workshops
MOH Hospitals.
Kazakhstan

10.02 76
Upper-Middle
2.6%
aged 30-70 yrs from 22.40% >10% (>25%) of
(0.1%)
income (%):i
Human Development
0.83
Years

(0.77): 28.6 (77)
very high
rank:f
High-technology
ICT Development
6.8 (52) exports (% of 29.80%
Index (rank):g

Website: https://www.gov.kz/memleket/entities/dsm?lang=en
http://adilet.zan.kz/eng/docs/K2000000360
https://www.ndda.kz/upload/736_%D0%9F%D1%80%D0%B8%D0%BA%D0%B0%D0%B7.docx
Ministry of health responsible for health technology policy implementation: Department of Medical and Pharmaceutical
Activity Monitoring (MoH).

Lists available: Yes, but it is only a recommendation For list of approved medical devices for
procurement we have the Medical State
Unit: National Expertise Center of pharmaceuticals, medical devices and equipment Register of Lekarstennyh.
(REM) within Republican state enterprise (RES).
Website: —
Website - hospitals: http://adilet.zan.kz/eng
Website: https://www.gov.kz/memleket/entities/dsm/activities/2217?lang=ru
e
Additional HTA contact: Zaid Zholdassov:
HTA unit/department includes the assessment of medical devices: Yes zholdassov_z@rcrz.kz. The HTA is
Unit/department: Republican Center for Health Development of the MoH: HTA focused on pharmaceutics, sometimes
deparment. performed for medical devices.
Website(s): https://www.gov.kz/memleket/entities/dsm?lang=en
http://rcrz.kz/index.php/ru/menedzhment-zdravookhraneniya/22-informatsiya/1233-
otsenka-meditsinskikh-tekhnologij2
Contact: Ms. Tulegalieva A. G. Email: —

Name of regulatory agency: Department of Medical and Pharmaceutical Activity National center of examination of drugs
Monitoring. (RGP), medical devices and medical
Website(s): https://www.gov.kz/memleket/entities/economy?lang=en equipment nazancheniya (MH RK).
https://www.ndda.kz/category/mainpage
Contact: Mr. Baiserkin B.S. Email: b.baiserkin@mz.gov.kz
Name(s) of other regulatory agency eg. for radiation equipment etc.: Commitee of atomic and energy supervision and
control of the Ministry of Energy of the Republic of Kazakhstan.
178 Other agency’s website: https://www.gov.kz/memleket/entities/kaenk?lang=en
WHO European Region
Kazakhstan
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed Medical State Register of lekarstennyh.
Use: Not specified
Website: https://www.ndda.kz/category/nomenklatura_men_izd

Procurement
Policy or guideline: Yes Website: https://www.ndda.kz/category/gos_zakup
National level procurement: Yes Website: https://www.gov.kz/memleket/entities/
dsm?lang=en
The procurement is done at a national
https://fms.ecc.kz/ru/searchanno level with the register of procurement of
Donations medical equipment. We have the National
Register of medical devices.
Policy or guideline: No Website: https://egov.kz/cms/en
Website: https://www.gov.kz/memleket/entities/dsm?lang=en
Density per
population

Unit/Department: AO Kazmedteh. Unit website: https://www.gov.kz/memleket/entities/kmfk?lang=en
http://kmtlc.kz/en/postavshchikam/trebovaniya-k-medicinskoy-tehnike1/
Contact name: Mr. Horoshash A. N. Contact email: —
Website with publically available technical specifications: http://kmtlc.kz/ru/postavshchikam/trebovaniya-k-medicinskoy-
tehnike1/
Type of inventories available: — Medical State Register of lekarstennyh.
Website: https://www.ndda.kz/category/gos_reestr_excel
https://www.ndda.kz/category/Gosudarstvennyi_reesttr
https://portal.dari.kz/
Use of management software: Yes Software name: AIS-TEP Program.

Contacts WHO Country officer(s):

National officer(s):
Name: Dr. Caroline Francoise Clarinval
Name: —
Email: — Email: clarinvalc@who.int
Name: Mr. Horoshash A. N. Name: —

General comments (...Annex 1): Concerning the Infrastructure section: the division for 20 beds on health centres
is not applicable for the Kazakhstan centres network.
Kenya

41.87 56
Lower-Middle
5.4%
aged 30-70 yrs from 21.00% >10% (>25%) of
(1.5%)
income (%):i
Human Development
0.6
Years

(0.44): 26.1 (86)
medium
rank:f
High-technology
ICT Development
2.9 (138) exports (% of 4.60%
Index (rank):g

Website: —
Language(s): —

Lists available: Yes, but it is only a recommendation Lists are developed locally and available in
hard copy only. Lists for procedures only
Unit: Biomedical Engineering Department. cover surgical procedures.
Website: —
Lists available: Yes It only covers surgical procedures which
are locally developed. No available.
Website: —
e
The development of HTA framework for
HTA unit/department includes the assessment of medical devices: No health products is in progress.
Website(s): —

Name of regulatory agency: — Kenya has demonstrated its commitment
Website(s): Kenya Pharmacy and Poisons Board to improve the national legal and
regulatory framework for radiation safety.
Contact: Dr. Fred Siyoi Email: fmsiyoi@gmail.com Currenty, The Radiation Protection Board
(RPB) regulates such activities in Kenya,
Name(s) of other regulatory agency eg. for radiation equipment etc.: The Radiation including those with sealed and unsealed
Protection Board (RPB) radioactive sources as well as X-ray and
other radiation-emitting devices.
Other agency’s website: https://www.iaea.org/newscenter/pressreleases/iaea-mission-
kenya-committed-to-radiation-safety-needs-to-ensure-regulatory-bodys-independence
180
WHO African Region
Kenya
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: The GMDN is used for regulatory purposes
For regulatory purposes
Website: —

Procurement
National level procurement: Yes Website: http://www.kemsa.co.ke/
Donations The procurement at a national level is
Policy or guideline: Yes Website: — specifically done at the Ministry of Health.
Guidelines for donations: IEC 60601, ISO
Technical specifications 13485, Directive 93/42/EEC.
Website: —
Density per
population

Unit/Department: Biomedical Engineering Division. Unit website: —
Contact name: Mr. Martin Owino Contact email: Martin.owino@yahoo.com
Type of inventories available: National inventory for medical equipment Locally developed.
Website: —

Contacts
Name: Mr. Martin Owino Name: Dr. Rudi Eggers
Email: martin.owino@yahoo.com Email: eggersr@who.int
Name: — Name: Dr. Regina Mbindyo
Email: — Email: mbindyor@who.int
General comments (...Annex 1): The corresponding technical specifications, as well as donation guidelines are
available upon request in soft copy (not pdf versions).
Kiribati

49.59 51
Lower-Middle
aged 30-70 yrs from 50.90% >10% (>25%) of — (—)
income (%):i
Human Development
0.63
Years

(0.52): — (—)
medium
rank:f
High-technology
ICT Development
2.2 (154) exports (% of —
Index (rank):g

Website: —
Language(s): —
Approved devices lists comments
National lists of medical devices (...Annex 1):
We do not have a standard list in place but
National list of approved priority/essential medical devices, we do overseas and local procurement
(including IVDs), for procurement or reimbursement: for specific medical devices needed for
MoH; e.g., in 2009 overseas procurement
Lists available: Yes for medical devices was made through
Unit: Tungaru Central Hospital, Medical and Pharmacy Stores. medical healthcare prioritization according
to doctors and head nurses. The selection
Website: — and orders of medical devices were made
to medical suppliers (such as South Austral
Nomenclature systems used for devices and tests: — We do not have a standard list in place but
National list for specific clinical interventions/emergencies: we do overseas and local procurement
for specific medical devices needed for
Lists available: Yes MoH; e.g., in 2009 overseas procurement
Website: — for medical devices was made through
medical healthcare prioritization according
to doctors and head nurses. The selection
e
—
Website(s): —

Website(s): —
182
Kiribati
Website: —

Procurement
Donations The donations are second-hand medical
Policy or guideline: Yes Website: — devices from churches (LDS & CCatholics);
such as defibrillator, computer, patient
Technical specifications monitor-propaq, dressing trolleys.
Website: —
Density per
population
Mammograph:α,* 0 0
Radiotherapy:β 0 0

Type of inventories available: National inventory for medical equipment We have the inventory record and
monitoring system with medical stores/
Website: — clinical wards/community health centres. In
Use of management software: No Software name: — the case there is no inventory for specific
medical equipment we refer to overseas
medical supplier for assistance and good
advices. In some cases there is inventory
only for high cost technologies (such as
Number of biomedical/clinical engineers professionals in the country:γ <10 MRI, CT or PET scanners).
Contacts
Name: Ms. Akineti Bauro Name: Dr. Wendy Dawn Snowdon
Email: bauroakineti@yahoo.com Email: snowdonw@who.int
Name: Dr. Teatao Tiira Name: —
General comments (...Annex 1): Medical devices components such as tools, knowledge, skills, repair and
maintenance are very crucial and essential therefore Kiribati is very fortunate to be part of this surveillance thus is the only
way to maintain our QA/QI (quality assurance and quality improvement) to achieve MoH objectives (utilization of quality
medical/nursing care to all Kiribati individual patient/client to provide patient’s safety, quality health care services and
patient’ satisfaction). We would appreciate being advised in ongoing training especially for nurses.
Kuwait

8.86 70
High
aged 30-70 yrs from 11.90% >10% (>25%) of — (—)
income (%):i
Human Development
Years

28.4 (78)
rank:f
High-technology
ICT Development
6 (71) exports (% of 0.90%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
It has been started the institutionalizing of
HTA unit/department includes the assessment of medical devices: No HTA within the MoH, with activities such as
Unit/department: — the building capacity.
Website(s): —

Website(s): —
Other agency’s website: https://www.iaea.org/newscenter/news/iaea-assists-efforts-to-
strengthen-kuwaits-legal-framework
184
Kuwait
Website: —

Procurement
Donations —
Website: —
Density per
population

Website: —

Contacts
Name: — Name: Dr. Assad Hafeez
Email: — Email: hafeeza@who.int
Name: — Name: —
Kyrgyzstan

17.53 70
Lower-Middle
3.5%
aged 30-70 yrs from 20.30% >10% (>25%) of
(0.7%)
income (%):i
Human Development
Years

24.5 (94)
rank:f
High-technology
ICT Development
4.4 (109) exports (% of 6.80%
Index (rank):g

Website: http://www.pharm.kg/ru/legislation/
http://www.pharm.kg/ru/live_important/
http://www.pharm.kg/upload/LAW%20on%20Health%20Protection%20in%20KG.doc
Ministry of health responsible for health technology policy implementation: Department of Medicines and Medical Devices
under Ministry of Health of the Kyrgyz Republic.

Lists available: Yes Standards: The law on the Health
Care institutions. We have lists for
Unit: Ministry of Health. communicable diseases, and public health
emergency situations, as well as clinical
Website: www.med.kg; http://www.pharm.kg/ protocols. The register of registered
Nomenclature systems used for devices and tests: GMDN. medical equipment is made at the website
Lists available: Yes Equipment timesheets are available, but
without the use of nomenclature.
Website - hospitals: http://www.pharm.kg/ru/medicalequipment/
http://www.who.int/medical_devices/survey_resources/medical_devices_
by_facility_kyrgyzstan.pdf; http://www.pharm.kg/upload/%D0%9F%D1%8
0%D0%B8%D0%BB%D0%BE%D0%B6%D0%B5%D0%BD%D0%B8%D0%B5%201_1.pdf
Website - laboratories: http://212.112.103.101/reestr
Lists available: Yes Clinical protocols.
Website: http://www.pharm.kg/ru/live_important/
e
—
Unit/department: Department of Medicines and Medical Devices under Ministry of
Health of the Kyrgyz Republic.
Website(s): http://www.pharm.kg/ru/live_important/
Contact: Ms. Ainura Abalieva Email: abalieva-a@yandex.ru

Name of regulatory agency: Department of Medicines and Medical Devices under —
Ministry of Health of the Kyrgyz Republic.
Website(s): http://www.pharm.kg/
http://www.med.kg/ru/
Contact: Ms. Ainura Abalieva Email: abalieva-a@yandex.ru
Name(s) of other regulatory agency eg. for radiation equipment etc.: National Institute of Standardization and Metrology.
186 Other agency’s website: http://www.nism.gov.kg/
WHO European Region
Kyrgyzstan
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: The nomenclature is used for various
For various purposes purposes: regulation, procurement, in-vitro
diagnostics lists and inventory.
Website: http://cbd.minjust.gov.kg/act/view/ru-ru/11978
http://cbd.minjust.gov.kg/act/view/ru-ru/111673; http://www.pharm.kg/ru/about

Procurement
Policy or guideline: Yes Website: http://zakupka.med.kg/ru/
http://cbd.minjust.gov.kg/act/view/ru-ru/94539/10?cl=ru-ru; Medical device incorporation
National level procurement: Yes Website: http://zakupka.med.kg/ru/
Kyrgyz Republic National Health Care
http://www.med.kg/ru/ Reform Program “Manas taalimi”.
Donations Procurements are carry out through the
National (budget) or donor projects.
Website: No
Density per
population

Unit present: No Professionally trained biomedical/clinical engineers: No
Unit/Department: Ministry of Health. Unit website: http://www.med.kg
http://www.med.kg/index.php/en/
Contact name: Ms. Dinara Sagynbaeva Contact email: —
Website with publically available technical specifications: http://lisenzya.med.kg/images/myFile/2018/otraslevye_standarty_
gemodializa.doc
Type of inventories available: National inventory for medical equipment The National Register for Medical
Equipment and the National Functional
Website: http://www.pharm.kg Register for Medical Equipment. The
Use of management software: Yes Software name: Nationally developed database National Functional Register for the
Medical Equipment is a database for
for material and technical facilities/medical facilities of public health institutions. medical facilities of the public health
institutions; meanwhile, the National
Medical devices workforce Register of the Medical Equipment is
a national list of pharmaceuticals and
Number of biomedical/clinical engineers professionals in the country:γ <10 medical equipment authorized and
registered for utilization in the Kyrgyz
Republic. A database is employed for
Contacts material and technical facilities and medical
Name: Ms. Ainura Abalieva Name: Dr. Nazira Poolatovna Artykova.
Email: abalieva-a@yandex.ru Email: artykovan@who.int
Name: Ms. Larisa Kachybekova Name: Ms. Saltanat Moldoisaeva
Email: — Email: moldoisaevas@who.int

Lao People’s Democratic Republic

44.08 50
Lower-Middle
aged 30-70 yrs from 26.80% >10% (>25%) of — (—)
income (%):i
Human Development
0.61
Years

(0.46): 20.6 (113)
medium
rank:f
High-technology
ICT Development
2.9 (139) exports (% of 20.60%
Index (rank):g

Website: —
Language(s): Lao and English
Ministry of health responsible for health technology policy implementation: Medical Products Supply Center.

Unit: —
Website: —
Website: —
e
HTA unit/department includes the assessment of medical devices: No of HTA systems by establishing nodal
Unit/department: — agencies and conducting ad-hoc activities.
Website(s): — national unit. The creation of a national
Contact: — Email: — health insurance authority towards the
UHC goal is in progress.

Name of regulatory agency: Food and Drug Department There is the political will to strenghten
Website(s): https://moh.gov.la/ the Nuclear and radiation safety and
security, as well as the corresponding legal
Contact: Dr. Somthavy Changvisommit Email: csomthavy_fdd@yahoo.com framework (as seen in the 2020-2025
Name(s) of other regulatory agency eg. for radiation equipment etc.: Health Care plan).
Deparment.
Other agency’s website: https://www.iaea.org/newscenter/news/lao-peoples-democratic-republic-signs-its-second-country-
programme-framework-cpf-for-2020-2025
188

Not specified
Website: http://www.fdd.gov.la/index_en.php

Procurement
Donations The procurement at a national level is only
Policy or guideline: Yes Website: — for sophisticate and high-value equipment.
Website: —
Density per
population
Mammograph:α,* 0 0

Unit/Department: Health Care Department. Unit website: —
Contact name: Dr. Chanhphomma Vongsamphanh Contact email: —
Type of inventories available: National inventory for medical equipment In the whole country, the inventories are
ongoing .
Website: —
Use of management software: Yes Software name: PLAMAHS.

Contacts
Name: Mr. Thanom Insal Name: Dr. Ying-Ru Jacqueline Lo
Email: mpsc@laotel.com Email: loy@who.int
Name: Dr. Chanhphomma Vongsamphanh Name: Ms. Sengphet Phongphachanh
Email: — Email: phongphachanhs@wpro.who.int
Latvia

4 72
High
aged 30-70 yrs from 21.60% >10% (>25%) of — (—)
income (%):i
Human Development
0.87
Years

(0.78): 41.1 (36)
very high
rank:f
High-technology
ICT Development
7.3 (35) exports (% of 17.20%
Index (rank):g

Website: https://likumi.lv/
Language(s): Latvian
Ministry of health responsible for health technology policy implementation: Regulation of Cabinet of Ministers No. 581
(adopted 02082005).

Unit: —
Website: —
Website - hospitals: http://www.pharm.kg/ru/live_important/
Website - laboratories: https://eur-lex.europa.eu/legal-content/LV/TXT/
HTML/?uri=CELEX:32017R0746&from=LV
Lists available: Yes Regulation of Cabinet of Ministers No. 60.
Website: http://www.likumi.lv/doc.php?id=187621
e
—
Unit/department: State Agency of Medicines.
Website(s): https://www.zva.gov.lv/en/director/health-technology-assessment-department
http://www.vmnvd.gov.lv/
Contact: Ms. Daiga Behmane Email: daiga.lagzdina@zva.gov.lv

Name of regulatory agency: State Agency of Medicines. —
Website(s): http://www.zva.gov.lv
Contact: Ms. Daiga Lagzdina Email: daiga.lagzdina@zva.gov.lv
Other agency’s website: https://www.vvd.gov.lv/lv/pakalpojumi/darbibas-ar-jonizejosa-
starojuma-avotiem
190
WHO European Region
Latvia
Website: http://www.zva.gov.lv of MD representatives (of both the
https://www.gmdnagency.org/ national MoH and the national agencies)
Procurement
National level procurement: Yes Website: https://www.zva.gov.lv/
Donations The procurement of national devices at a
Policy or guideline: No Website: — national level started from the year 2010.
Website: —
Density per
population

Unit/Department: Centre of Health Economics Unit website: https://www.vmnvd.gov.lv/en
Contact name: Ms. Iveta Gavare Contact email: iveta.gavare@vec.gov.lv
Website with publically available technical specifications: https://likumi.lv/ta/id/295401-medicinisko-iericu-registracijas-
atbilstibas-novertesanas-izplatisanas-ekspluatacijas-un-tehniskas-uzraudzibas-kartiba
Website: —

Contacts
Name: — Name: Dr. Uldis Mitenbergs
Email: — Email: umitenbergs@who.int
Name: Ms. Iveta Gavare Name: —
Email: iveta.gavare@vec.gov.lv Email: —
Lebanon

6.98 72
Lower-Middle
aged 30-70 yrs from 19.90% >10% (>25%) of — (—)
income (%):i
Human Development
Years

26 (87)
rank:f
High-technology
ICT Development
6.3 (64) exports (% of 2.40%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
The HTA is at initial stages to inform health
HTA unit/department includes the assessment of medical devices: No policy and products. National strategy will
Unit/department: Projects and Health Programs. incorporate several actors: MoH, National
Social Security Funds, General Security,
Website(s): — etc.

Name of regulatory agency: Ministry of Public Health. It controls the importation of all
Website(s): http://www.moph.gov.lb/ radiological devices (x-ray devices, tracers
for nuclear medicine, etc.).
Council for Atomic Energy.
Other agency’s website: http://www.laec-cnrs.gov.lb/Authorization.asp?Cat=Programs&SubCat=Radiation%20Protection,%20
Safety%20And%20Security%20Of%20Radioactive%20Sources&SubCat2=Regulation,%20Authorization%20And%20Inspection%20
Of%20Ionizing%20Radiations%20field&MyPage=Authorization.asp&SubCat3=Inspection&MyPage=Authorization.asp
192
Lebanon
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified The Ministry of Health is planning to
acquire the Global Medical Devices
Website: https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20 Nomenclature system to adopt it and use it
Technology/Laws%20and%20Regulations/karar%201506-2014.pdf for regulatory and procurement purposes.

The procurement of medical equipment
Policy or guideline: No Website: — for public hospitals is done by the Council
National level procurement: No Website: — for Development and Reconstruction in
coordination with the Ministry of Public
Donations Health. A procurement procedure and
Policy or guideline: No Website: — bidding documents are used and adapted
according to the specific project and
Technical specifications considering the government rules for
procurement. No guidelines exist in the
Technical specifications to support procurement or donations: Yes private sector that is dominating the health
Publically available: No sector (80% of beds are private).
Website: —
Density per
population

Unit/Department: Projects & Health Programs. Unit website: —
Contact name: Ms. Sizar Akoum Contact email: sizarak@hotmail.com
Type of inventories available: National inventory only for high cost technologies The Ministry of Health has acquired
a GIS licence to establish a database
(such as MRI, CT or PET scanners). which will include the available high-cost
Website: — technologies.

Contacts
Name: Ms. Sizar Akoum Name: Dr. Iman Shankiti
Email: sizarak@hotmail.com Email: shankitii@who.int
Name: — Name: Dr. Alissar Rady
Email: — Email: radya@who.int
Lesotho

89.52 48
Lower-Middle
4.5%
aged 30-70 yrs from 42.70% >10% (>25%) of
(1.4%)
income (%):i
Human Development
0.53
Years

(0.38): — (—)
low
rank:f
High-technology
ICT Development
3 (133) exports (% of 0.20%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): —
194
WHO African Region
Lesotho
Website: —

Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: — Name: Dr. Richard Banda
Email: — Email: bandar@who.int
Name: — Name: —
Liberia

78.28 42
Low
aged 30-70 yrs from 17.80% >10% (>25%) of — (—)
income (%):i
Human Development
0.48
Years

(0.33): — (—)
low
rank:f
High-technology
ICT Development
Index (rank):g

Website: —
Language(s): —

Lists available: No Lists of standards and lists are: “Basic
Package of Health Services” which
Unit: — contains a list of the equipment at the
“annexe”. However, the list is subject to
Website: — revision. The WHO guidelines are being
Nomenclature systems used for devices and tests: — used for donations. The process has
been initiated for the adaptation of the
National list for different types of healthcare facilities guidelines.
Lists available: — Health care facilities lists comments
(...Annex 1):
—
Lists available: No The list of equipment can be found in the
index of the following document Basic
Website: — Package of Health Services. However, the
list is subject to revision.
e
—
Website(s): —

Name of regulatory agency: Liberia Medicines & Health Products Regulatory Currently, there is a National Drug
Authority (LMHRA). Regulatory Authority that is in the process
Website(s): https://www.lmhra.org/ of institutonalization.
196
WHO African Region
Liberia
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified No comments as the nomenclature does
not exist.
Website: —

Procurement
Donations The procurements are based on the WHO
Policy or guideline: Yes Website: — guidelines and they are mainly organized
through partners.
Website: —
Density per
population


Type of inventories available: National functional inventory for medical equipment The functional inventory of medical
equipment is ongoing. The focus is to take
Website: — inventory of all equipment in the Public
Use of management software: No Software name: — Health facilties.

Contacts
Name: Mr. Thomas K. Nagbe Name: Dr. Lugala Peter Lasuba Clement
Email: tnknue31112@gmail.com Email: clementp@who.int
Name: Dr. Louise Kpoto Name: Mr. Eric Johnson
Email: — Email: johnsoner@who.int
Libya

11.13 60
Upper-Middle
aged 30-70 yrs from 18.60% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
4.1 (115) exports (% of —
Index (rank):g

Website: http://health-ministry.ly/
http://seha.ly/en/
Language(s): Arabic
Ministry of health responsible for health technology policy implementation: Pharmacy and Medical Devices Department.

Lists available: Yes, but it is only a recommendation There are national standards lists but they
are not written. There are lists for Sundries
Unit: — Hospital consumable- Diagnostics
Laboratory 37/3.
Website: —
Lists available: Yes There are national standards lists but
are not written. It exists also lists for
Website: — interventions, and emergencies. See
the following file: General_terms_and_
conditions_for_medicines_and_medical_
e
National health technology assessment unit consumables_and_equipment.
HTA unit/department includes the assessment of medical devices: No —
Website(s): —

Name of regulatory agency: Pharmacy Management, Equipment, Supplies and The Medical Supply Organization (MSO)
Medical Supplies Ministry of Health. is responsible for the procurement of
Website(s): http://www.health.gov.ly/ medical appliances for the public sector.
Contact: Dr. Mahdi Al Ekary. Email: pharmacy912@yahoo.com

Name(s) of other regulatory agency eg. for radiation equipment etc.: Medical
Supply Organization (MSO).
Other agency’s website: https://gnssn.iaea.org/main/ANNuR/Activity%20Documents%20%20Public/Regional%20Workshop%20
and%20Seminar%20on%20Capacity%20Building,%20Education%20and%20Training%20Review%20Service%20(ETRES)/National%20
presentation-%20Libya.pdf
198
Libya
C3D4 Official nomenclature system for medical devices: Yes Type: Based on UMDNS Use: For the medical equipment list, it is used
For various purposes a nomenclature based on the UMDNS.
The nomenclature is used for inventory
Website: http://www.mhtc.ly systems of healthcare facilities and lists.
https://seha.ly/en

Procurement
Donations In regards to the technical specifications
Policy or guideline: No Website: — of medical devices, we depend mainly on
the technical committees which consist
Technical specifications of experts in medicine, pharmacy and
Technical specifications to support procurement or donations: No biomedical engineer. These committees
set up decrees issued by the Secretariat of
Publically available: — Health.
Website: —
Density per
population

Unit/Department: Pharmacy and Medical Equipment Administration. Unit website: http://health-ministry.ly/
http://seha.ly/en/
Contact name: Dr. Nasereddin Emhemed Alriyani Contact email: —
Type of inventories available: National inventory for medical equipment The last version is from 2006.
Website: —

Contacts
Name: Mr. Ezzedin S. Z. Durar Name: Dr. Elizabeth Hoff
Email: edurar2004@yahoo.com Email: hoffe@who.int
Name: Dr. Nasereddin Emhemed Alriyani Name: Ms. Najwa El-Emam
Email: — Email: elemamn@who.int
General comments (...Annex 1): This is the first time for us to participate in this survey. Our standards and policies
are under development and/or being updated. Many issues in this survey are available but still not documented.
“General_terms_and_conditions_for_medicines_and_medical_consumables_and_equipment”
Lithuania

3.28 70
High
9.8%
aged 30-70 yrs from 19.30% >10% (>25%) of
(1.6%)
income (%):i
Human Development
0.88
Years

(0.79): 39.2 (40)
very high
rank:f
High-technology
ICT Development
7.2 (41) exports (% of 12.00%
Index (rank):g

Website: https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/35834810004f11e4b0ef967b19d90c08/asr
Language(s): Lithunian
Ministry of health responsible for health technology policy implementation: Ministry of Health.

Lists available: Yes Licensing regulations for health care
facilities. General and specific requirements
Unit: Public Procurement Office operating under the Ministry of Economy. for institutional health care services.
There is a list of medical devices that are
Website: http://www.who.int/medical_devices/survey_resources/medical_devices_for_ mandatory for specialized and surgical
procurement_reimbursement_lithuania.pdf health care services. Public Procurement
Website - hospitals: https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.293780
Website - laboratories: https://vaspvt.gov.lt/en/node/276 Specific lists comments (...Annex 1):
https://vaspvt.gov.lt/files/Medicinos_prietaisai/sarasas_20-11-17.pdf These are lists of indications and
reimbursement regulations for expensive
Nomenclature systems used for devices and tests: — health technology examination techniques
National list for specific clinical interventions/emergencies: (e.g. CT, MRI) and diagnostic procedures
(e.g. diagnostic interventional procedures).
Lists available: Yes Only available in lithuanian language.
Website: http://www3.lrs.lt/pls/inter3/dokpaieska.showdoc_l?p_id=258027 General and specific requirements for
institutional health care services. There is a
list of medical devices that are mandatory
e
—
Unit/department: Health Technology Division of State Health Care Accreditation
Agency under the Ministry of Health.
Website(s): http://www.vaspvt.gov.lt/en/node/270
http://www.hi.lt/
Contact: Ms. Neringa Puidokiene Email: neringa.puidokiene@vaspvt.gov.lt

Name of regulatory agency: State Health Care Accreditation Agency under the —
Ministry of Health of the Republic of Lithuania.
Website(s): www.vaspvt.gov.lt
Contact: Ms. Jolanata Karavackaite Email: jolanta.karavackaite@vaspvt.gov.lt
Name(s) of other regulatory agency eg. for radiation equipment etc.: State Nuclear
Power Safety Inspectorate (VATESI); Radiation Protection Centre (Ministry of Health).
Other agency’s website: http://www.vatesi.lt/index.php?id=2
http://www.rsc.lt/index.php/pageid/418
200
WHO European Region
Lithuania
Website: http://www.vaspvt.gov.lt/en of MD representatives (of both the
Policy or guideline: Yes Website: http://www3.lrs.lt/pls/inter3/dokpaieska.showdoc_l?p_
id=448409&p_query=&p_tr2=2 Medical device incorporation
http://www3.lrs.lt/pls/inter3/dokpaieska.showdoc_l?p_id=443967&p_query=&p_tr2=2 comments (...Annex 1):
Guidelines for procurement of expensive
National level procurement: Yes Website: http://www3.lrs.lt health technologies (i.e. MRI, CT etc.).
Donations Guidelines are in the Lithuanian language
only. There are basic requirements for
Policy or guideline: Yes Website: http://www3.lrs.lt/pls/inter3/dokpaieska.showdoc_l?p_ technical specification of medical devices
id=228695&p_query=&p_tr2= that are procured in a public centralized
way.
Website: https://www.lrs.lt/
Density per
population

Unit/Department: Medical Devices Surveillance Division of State Health Care Accreditation Agency under the Ministry of
Health. Unit website: https://vaspvt.gov.lt/node/106
http://www.vaspvt.gov.lt/en/node/275
Contact name: Ms. Jolanta Karavackaite Contact email: jolanta.karavackaite@vaspvt.gov.lt
Website with publically available technical specifications: http://www3.lrs.lt/pls/inter3/dokpaieska.showdoc_l?p_id=336532
https://vaspvt.gov.lt/en/node/276; https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.336532
Type of inventories available: National inventory only for high cost technologies The State Health Care Accreditation
Agency, under the Ministry of Health,
(such as MRI, CT or PET scanners) is responsible for the management of
Website: — national data regarding expensive health
technologies (i.e. MRI, CT, etc.).

Contacts
Name: Ms. Nora Ribokien_ Name: Ms. Ingrida Zurlytè
Email: vaspvt@vaspvt.gov.lt Email: zurlytei@who.int
Name: — Name: Mr. Robertas Petkevicius
Email: — Email: per@euro.who.int
Luxembourg

2.78 86
High
3.4%
aged 30-70 yrs from 9.80% >10% (>25%) of
(0.2%)
income (%):i
Human Development
0.92
Years

(0.83): 50.8 (18)
very high
rank:f
High-technology
ICT Development
8.5 (9) exports (% of 6.60%
Index (rank):g

Website: https://sante.public.lu/fr/politique-sante/ministere-sante/index.html
http://legilux.public.lu/eli/etat/leg/memorial/2009/54
Language(s): —
Ministry of health responsible for health technology policy implementation: Direction de la Santé.

Unit: —
Website: —
Website - hospitals: http://legilux.public.lu/eli/etat/leg/loi/2001/06/20/n2/jo
Website - laboratories: https://cns.public.lu/en/professionnels-sante/medicaments/
dispositifs-medicaux.html
Lists available: Yes Contenues notamment dans le plan
pandémie grippale qui n’est pas sur
Website: http://legilux.public.lu/eli/etat/leg/loi/1986/02/27/n1/jo l’internet public.
http://legilux.public.lu/eli/etat/leg/rmin/2006/02/14/n5/jo (blood transfution)
https://sante.public.lu/fr/legislation/index.
php?q=directive+93%2F42%2FCEE&~=do&from=search (implantables)
e
—
Unit/department: Cellule d’expertise Médicale (CEM).
Website(s): https://cem.gouvernement.lu/fr.html
https://igss.gouvernement.lu/fr/service.html
Contact: Dr. Isabelle Rolland Email: isabelle.rolland@igss.etat.lu

Name of regulatory agency: Ministère de la Santé. —
Website(s): https://sante.public.lu/fr/politique-sante/ministere-sante/direction-sante/index.
html; https://sante.public.lu/fr/politique-sante/ministere-sante/direction-sante/div-medecine-
curative/index.html; http://legilux.public.lu/eli/etat/leg/rgd/1981/12/08/n3/jo
Contact: Dr. Anna Chioti Email: meddevices@ms.etat.lu
Name(s) of other regulatory agency eg. for radiation equipment etc.: Division de la Médecine Curative et de la Qualité en
santé; Ministère-Direction de la Santé.
Other agency’s website: https://sante.public.lu/fr/politique-sante/ministere-sante/direction-sante/div-medecine-curative/index.html
202
WHO European Region
Luxembourg
Website: https://cns.public.lu/fr/professionnels-sante/medicaments/dispositifs-medicaux. of MD representatives (of both the
html national MoH and the national agencies)
Procurement
Donations —
Website: —
Density per
population

Unit/Department: Direction de la Santé. Unit website: —
Contact name: None Contact email: None
Type of inventories available: National inventory only for high cost technologies Software choisi par chaque hôpital
individuellement.
Website: https://cns.public.lu/fr/professionnels-sante/medicaments/dispositifs-medicaux.
html
https://sante.public.lu/
Use of management software: Yes Software name: Le Software est choisi par
chaque hôpital individuellement.

Contacts
Name: Dr. Françoise Berthet Name: —
Email: francoise.berthet@ms.etat.lu Email: —
Name: Mr. Carlo Back Name: —
Email: carlo.back@ms.etat.lu Email: —

Madagascar

50.24 35
Low
1.6%
aged 30-70 yrs from 26.00% >10% (>25%) of
(0.2%)
income (%):i
Human Development
0.53
Years

(0.39): 20.4 (115)
low
rank:f
High-technology
ICT Development
1.7 (169) exports (% of 0.50%
Index (rank):g

Website: —
Ministry of health responsible for health technology policy implementation: Service des Equipements et de la Maintenance.

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): —
204
WHO African Region
Madagascar
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed Nomenclature nationale pour la
Use: Not specified comptabilité matière du patrimoine
de l’Etat (codification pour l’inventaire
Website: http://www.agmed.mg/ technique).

Procurement
Donations Specifications techniques pour: Matériels
Policy or guideline: Yes Website: — et équipements pour les Centres de Santé
de base; matériels et équipements de
Technical specifications laboratoire pour les Centres Hospitaliiers
Technical specifications to support procurement or donations: Yes de Districts de niveau 2; matériels et
équipements biomédicaux et hospitaliers
Publically available: No pour les Centres Hospitaliers de Districts
de niveau 2.
Website: —
Density per
population

Unit/Department: Service d’Appui aux Hôpitaux de Référence Nationaux et Régionaux (SAHRNR). Unit website: —
Contact name: — Contact email: siem@sante.gov.mg
Type of inventories available: National functional inventory for medical equipment Inventaire effectué en 2007 avec le projet
CRESAN 2 (55 Centre Hospitalier de
Website: — District de niveau 1 (CHD1), 29 Centres
Use of management software: No Software name: — hospitalier de Districts de niveau 2 (CHD2),
18 Centres Hospitalier de Référence
Régionale (CHRR), 10 Centre Hospitalier
Universitaire (CHU) et Etablissements
Sanitaires. Mise à jour en cours.
Contacts
Name: — Name: Dr. Marcellin Nimpa Mengouo
Email: — Email: nimpamengouom@who.int
Name: Chef de Service Name: —
Email: siem@sante.gov.mg Email: —
General comments (...Annex 1): Formation en maintenance biomedicale a Madagascar: Depuis 1980, la
multiplication des établissements hospitaliers et l’avenement des nouvelles technologies au service de santé ont induit une
arrivée massive et diversifiée d’appareillages biomédicaux et ont fait apparaître le problème crucial de leur maintenance.
La dernière action de recyclage (formation continue) des techniciens date de 2001.
Malawi

38.58 48
Low
4.2%
aged 30-70 yrs from 22.60% >10% (>25%) of
(0.9%)
income (%):i
Human Development
0.48
Years

(0.35): 21.4 (111)
low
rank:f
High-technology
ICT Development
1.7 (167) exports (% of 7.30%
Index (rank):g

Website: https://m.facebook.com/malawimoh/
Language(s): —
Ministry of health responsible for health technology policy implementation: Physical Assets Management Division.

Lists available: Yes The standard list provided is for health
centres, community hospitals and district
Unit: Physical Assets Management. hospitals. The standard list for central
hospitals is being developed and will be
Website: — published very soon (file names: “jica” and
Nomenclature systems used for devices and tests: — “customer”, respectively).
Website: —
e
—
Website(s): —

Name of regulatory agency: — Radiation protection and nuclear safety
Website(s): https://m.facebook.com/malawimoh/ is done via AERA and it is in process of
institutionalization.
Contact: Mr. Godfrey Kadewere Email: gkadds@gmail.com
Energy Regulatory Authority
Other agency’s website: https://www.iaea.org/sites/default/files/19/10/malawi_overview_2019.pdf
206
WHO African Region
Malawi
Website: —

Procurement
Donations There are the following pdf files: the
Policy or guideline: Yes Website: — “Public Procurement Act (2003)”, the
“Desk Instructions”, and the “Procurement
Technical specifications Regulations”.
Website: —
Density per
population
Mammograph:α,* 0 0
Radiotherapy:β 0 0

Unit/Department: Physical Assets Management. Unit website: —
Contact name: Dr. Lovemore Mkukuma. Contact email: mkukuma@yahoo.co.uk
Type of inventories available: National inventory for medical equipment The inventory is in a database known as
“Planning and Management of Assests in
Website: — Health Sector (PLAMAHS)” and is not yet
Use of management software: Yes Software name: Planning and Management of online.
Assets in Health Sector (PLAMAHS).

Contacts
Name: — Name: Dr. Nonhlanhla Dlamini
Email: — Email: dlaminin@who.int
Name: — Name: Mr. Wilfred Dodoli
Email: — Email: dodoliw@who.int
Malaysia

8.62 76
Upper-Middle
2.0%
aged 30-70 yrs from 18.50% >10% (>25%) of
(0.2%)
income (%):i
Human Development
Years

42.4 (33)
rank:f
High-technology
ICT Development
6.4 (63) exports (% of 51.80%
Index (rank):g

Website: —
Language(s): —

Lists available: No The corresponding lists are only prepared
based on the needs.
Unit: —
Website: —
Lists available: No There is no standardized list. It is based on
needs.
Website: —
e
Malaysian Health Technology Assessment
HTA unit/department includes the assessment of medical devices: Yes Section (MaHTAS) of the MoH performs
Unit/department: Health Technology Assessment Unit, Medical Development HTA for health products including medical
devices.
Division.
Website(s): https://www.moh.gov.my/
https://www.moh.gov.my/moh/resources/HTA_MANUAL_MAHTAS.pdf?mid=636
Contact: Dr. Izzuna Mudla Ghazali Email: izzuna@gmail.com

Name of regulatory agency: Medical Device Authority, Ministry of Health Malaysia. The Medical Device Act 2012 (Act 737)
Website(s): https://portal.mda.gov.my/ has come into force on June 30th
2013, while the effective date for its
Contact: Mr. Zamane Bin Abdul Rahman Email: zamane@mdb.gov.my subsidiary legislations, the Medical Device
Regulations (MDR) 2012 was on July 1th
Name(s) of other regulatory agency eg. for radiation equipment etc.: Atomic 2013. Act 737 provides two and one years,
Energy Licensing Board, Ministry of Science, Technology and Innovation. respectively, of a transition period for the
industry to submit applications for medical
Other agency’s website: https://www.aelb.gov.my/malay/dokumen/perundangan/ device registration and establishment
RADIATION%20PROTECTION%20LICENSING%20REGULATIONS%201986.pdf licensing before the law is fully enforced.
It exists a separate unit for the regulation
of radiological equipment (i.e. within the
Ministry of Energy): Radiation Health
and Safety Section, Engineering Services
Division, Ministry of Health Malaysia:
208
Malaysia
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: —
Not specified
Website: https://portal.mda.gov.my/documents/guideline-documents/30-guidelines-on-
medical-device-registration-under-act-737-mda-gl-md-01-june-2014-2nd-edition/file.html

Procurement
Donations Depending on the types of Medical
Policy or guideline: No Website: — Devices. Some are procured at a national
level, some at the state level and some at
Technical specifications the hospital level.
Website: —
Density per
population

Unit/Department: Training Management Division. Unit website: https://mda.gov.my/
Website with publically available technical specifications: https://mmdr.mda.gov.my/
Website: https://mdar.mda.gov.my/frontend/web/index.php?r=carian
Use of management software: Yes Software name: Central Management
Information System.

Contacts
Name: — Name: —
Email: — Email: wpmyswr@who.int
Name: Dr. Asmah Samat Name: —
Email: asmah_samat@moh.gov.my Email: —
Maldives

6.46 69
Upper-Middle
10.3%
aged 30-70 yrs from 11.60% >10% (>25%) of
(4.1%)
income (%):i
Human Development
0.74
Years

(0.58): — (—)
high
rank:f
High-technology
ICT Development
5.3 (85) exports (% of 0.10%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Name of regulatory agency: Medicine and Therapeutic Goods / Maldives Food and —
Drug Authority.
Website(s): https://health.gov.mv/en
Contact: Ms. Shareefa Adam Manik Email: shareefa@health.gov.mv
Name(s) of other regulatory agency eg. for radiation equipment etc.: Medical
Device Authority, Ministry of Health Malaysia.
210
Maldives
Website: http://health.gov.mv/

Procurement
National level procurement: Yes Website: http://health.gov.mv
Donations The procurement is done at a national level
Policy or guideline: No Website: — as well as for government health facilities.
Website: —
Density per
population
Radiotherapy:β 0 0

Website: —

Contacts
Name: — Name: Dr. Nazneen Anwar
Email: — Email: anwarna@who.int
Name: Ms. Aishath Mohamed Name: —
Email: anthu9696@hotmail.com Email: —
Mali

90.99 42
Low
6.5%
aged 30-70 yrs from 22.30% >10% (>25%) of
(1.1%)
income (%):i
Human Development
0.43
Years

(0.29): 19.2 (123)
low
rank:f
High-technology
ICT Development
2.2 (155) exports (% of 1.20%
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Division établissements sanitaires et
réglementation - Direction nationale de la Santé

Lists available: Yes Il n’existe pas de normes nationales pour
des procedures spécifiques, en général
Unit: — elles sont traitées au cas par cas. Non,
comme décrit précedemment, il n’existe
Website: — pas de liste spécifique de dispositifs
Nomenclature systems used for devices and tests: — médicaux pour les cas cités. La liste
Lists available: No Il n’existe pas de normes nationales pour
des procedures spécifiques , en général
Website: — elles sont traitées au cas par cas. Pour
diverses maladies et situations Il n’existe
pas de liste spécifique de dispositifs
e
National health technology assessment unit médicaux pour les cas cités.
The HTA is at initial stages to inform health
HTA unit/department includes the assessment of medical devices: — policy and products but not for medical
Unit/department: Cellule de Planification et de Statistique equipment.
Website(s): http://www.sante.gov.ml/
http://www.reforme-justice.gouv.ml/#/mjm/accueil

Name of regulatory agency: Division établissements sanitaires et réglementation - —
Direction nationale de la Santé.
Website(s): http://cnom.sante.gov.ml/
Contact: Dr. Yattara Moussa Email: —
212
WHO African Region
Mali
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed Il existe dans le document de la
Use: Not specified comptabilité matière une rubrique
nomenclature sommaire ou les différents
Website: — produits sont classés par catégories, mais
c’est un domaine très important qui mérite
une action.
Procurement
Donations Guidelines for procurement: existe
Policy or guideline: No Website: — un document de projet de politique
nationale en matière d’équipements et
Technical specifications d’infrastructures sanitaires qui traite ces
Technical specifications to support procurement or donations: Yes cas , mais il reste à être validé. Jusqu’à
l’adoption de la loi hospitalière. La DFM
Publically available: No était le seul organe d’achat de dispositifs
médicaux. Vue que cette loi accorde un
Website: — statut particulier à certaines structures
sanitaires notamment l’autonomie de
Density per gestion, mais aussi dans le cadre de
Medical equipment Total 1,000,000 la décentralisation il y a le transfert de
compétences entre le Ministère de la
population Santé et les collectivités territoriales, de
sorte que ces structures peuvent acheter
Magnetic Resonance Imaging:α 0 0 indépendamment

Unit/Department: DNS/ DFM/ SEPAUMAT et Departement des Affaires financières (DAF). Unit website: —
Contact name: Mr. Alamir Touré Contact email: alamirtoure@yahoo.fr
Type of inventories available: National functional inventory for medical equipment Chaque année le Ministère de la santé à
travers la DFM organise des inventaires
Website: — mixtes dans lesquels participent
Use of management software: No Software name: — comptables matières et techniciens
biomédicaux, dans toutes les structures
sanitaires du pays [centres de santé
communautaire (cscom) , centre de santé
de référence (csréf) et hôpitaux régionaux
Number of biomedical/clinical engineers professionals in the country:γ — (HR).Ensuite les differentes fiches sont
compilées et informatisés au niveau de la
division comptabilité matières.
Contacts
Name: — Name: Dr. Jean-Pierre Baptiste
Email: — Email: baptistej@who.int
Name: Mr. Alamir Touré Name: Mr. Alioune Ibnou Abytalib Diouf
Email: alamirtoure@yahoo.fr Email: adiouf@who.int
General comments (...Annex 1): Concerning the Infrastructure section: nous n’avons pas encore une politique
nationale pour les équipements mais nous y travaillons, nous avons tenu deux ateliers: l’un pour l’élaboration des élements
de la politique et l’autre pour la rédaction du document de politique. Le document attend sa validation lors d’un atelier
national pour être soumis à l’Assemblée Nationale. Concerning the Section Infrastructure: la Division établissements
sanitaires et réglementation (DESR) à la Direction Nationale de la Santé s’occupe également des établissements privés de
santé mais ne dispose pas de données à jour (2010) sur leur nombre exact.
Malta

6.46 81
High
15.9%
aged 30-70 yrs from 10.50% >10% (>25%) of
(2.8%)
income (%):i
Human Development
Years

46.4 (27)
rank:f
High-technology
ICT Development
7.9 (24) exports (% of 29.80%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website - hospitals: https://deputyprimeminister.gov.mt/en/cpsu/Documents/News/
Medical%20Devices%20Information%20Session/Medical%20Devices%20Presentation%20
CPSU%20seminar%20-%20May%202019.pdf
Website - laboratories: http://www.medicinesauthority.gov.mt/home?l=1
Website: —
e
Office of the Chief Medical Officer is
HTA unit/department includes the assessment of medical devices: No in charge to perform HTA, mainly in
Unit/department: — pharmaceutics.
Website(s): https://deputyprimeminister.gov.mt/en/pharmaceutical/Pages/assessment-unit.
aspx

Name of regulatory agency: Malta Standards Authority. —
Website(s): https://deputyprimeminister.gov.mt/en/cpsu/Pages/Reports/Stock-Reports.
aspx
Contact: Mr. David Pulis Email: david.pulis@msa.org.mt
Health (Medical Physics).
Other agency’s website: https://deputyprimeminister.gov.mt/en/ahcs/Pages/medicalphysics.aspx
214
WHO European Region
Malta
Website: http://www.medicinesauthority.gov.mt/medicaldevices of MD representatives (of both the
https://mccaa.org.mt/ national MoH and the national agencies)
Procurement
National level procurement: Yes Website: https://deputyprimeminister.gov.mt/en/
Pages/health.aspx
Procurement at national level: there is a
Donations strong collaboration between the two. For
capital expenditure for new technologies
Policy or guideline: No Website: — it is usually the department, for others it is
Technical specifications usually coordinated by the hospital itself.
Website: —
Density per
population

Type of inventories available: National inventory for medical equipment The name of the Software is Clingo from
the company Carestream Health Italia SRL.
Website: —
Use of management software: Yes Software name: Clingo.

Contacts
Name: Dr. Renzo Pace Asciak Name: —
Email: renzo.pace-asciak@gov.mt Email: —
Name: — Name: —
General comments (...Annex 1): The Ministry of Health has started to provide emphasis on new health technology
and its assessment. Over the last 2 years, it has been developed a short form and guidelines for the completion of all the
requests for the implementation of new health technologies and services. Together, the Director Generals for Strategy &
Sustainability, and Healthcare Services have met three times a year to evaluate the proposals received. It is envisaged that
a health technology evaluation unit will be developed in the short term.
Marshall Islands

30.67 62
Upper-Middle
aged 30-70 yrs from — >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Name of regulatory agency: Ministry of Health Board. —
Website(s): —
216
Marshall Islands
Website: —

Procurement
Donations —
Website: —
Density per
population
Radiotherapy:β 0 0

Type of inventories available: National inventory for medical equipment Inventory is not available.
Website: —

Contacts
Name: Ms. Mary Hicking Name: Dr. Palvin Boris
Email: mhicking@gmail.com Email: pavlinb@wpro.who.int
Mauritania

70.71 40
Lower-Middle
11.7%
aged 30-70 yrs from 16.10% >10% (>25%) of
(3.0%)
income (%):i
Human Development
0.55
Years

(0.37): — (—)
low
rank:f
High-technology
ICT Development
2.3 (151) exports (% of 0.00%
Index (rank):g

Website: https://www.sante.gov.mr/?page_id=516
Ministry of health responsible for health technology policy implementation: Des Infrastructures, du Materiel et de la
Maintenance (DIMM).

Unit: —
Website: —
Lists available: No Il existent des paquets d’activités par
niveau des soins de la pyramide sanitaire.
Website: —
e
—
Website(s): https://www.sante.gov.mr/?page_id=36
http://apps.who.int/iris/bitstream/handle/10665/259897/9789290312970-fre.
pdf?sequence=1

Name of regulatory agency: Direction de la Medecine Hospitaliere (DMH). Direction de la Medecine Hospitaliere
Website(s): https://www.sante.gov.mr/?page_id=34 qui a l’attribution de élabore et suit la
reglementation et les normes hospitaliere,
Contact: Dr. Moustapha Ould Abdallahi Email: — et prépare l’autorisation d’ouvertue a
titre privé des cliniques et des cabinets
Name(s) of other regulatory agency eg. for radiation equipment etc.: National de soins infirmier. Inspection General de
authority for radiation protection, safety and nuclear security (ARSN) la Santé (IGS) a l’attribution de verifier la
gestion des activités de l’ensembles des
Other agency’s website: https://www.iaea.org/sites/default/files/national_report_of_ services du departement et des organes
mauritania_for_the_6th_review_meeting_-_english.pdf sous tutelles, et leurs conformité aux lois et
reglement en vigeur cf voir organigramme
du ministere de la sante qui se trouve dans
le site web du ministere.
218
WHO African Region
Mauritania
Website: —

Procurement
Policy or guideline: Yes Website: https://www.sante.gov.mr/?wpfb_dl=205
National level procurement: Yes Website: https://www.sante.gov.mr/?wpfb_dl=205
Donations Il existe un plan de passation des Marchés
Policy or guideline: No Website: — (search for the document admin07 in the
specified website). Il existe le Centrale
Technical specifications d’Achat des Médicaments, Equipements
Technical specifications to support procurement or donations: No et Consommables Médicaux (CAMEC)
en ce qui concerne la procuration des
Publically available: — equipments medicaux: http://www.
Website: — camec.mr/
Density per
population

Unit/Department: Direction des Infrastructures, du Materiel et de la Maintenance. Unit website: https://www.sante.gov.
mr/?page_id=34
Contact name: Mr. Roughaya Habott Contact email: hroughaya@yahoo.fr
Website with publically available technical specifications: https://www.sante.gov.mr/?p=2094
Type of inventories available: None Un inventaire technique national
etait diponible dans une base de
Website: — donnée informatisée (GMAO) qui est
Use of management software: No Software name: — malheusement deectueuse depuis 2004,
et qui n’a jamais été actualisé au niveau
national.
Contacts
Name: Mr. Roughaya Habott Name: Dr. Charlotte Faty Ndiaye
Email: hroughaya@yahoo.fr Email: ndiayechar@who.int
Name: — Name: Mme. Aminata Sakho Kelly
Email: — Email: kellyas@who.int
General comments (...Annex 1): Le suivi de la

maintenance des équipements est une mission confiée à la Direction des Infrastructures, du Matériel et de la Maintenance
(DIMM) et mis en œuvre par le service de la Maintenance. Le service de la maintenance comprend deux divisions :-
Division de la maintenance des infrastructures;- Division de la maintenance des équipements et des matériels. Le service
de la maintenance dispose d’un plateau technique composé, au niveau central de 7. techniciens biomédicaux, de 2
ingénieurs biomédicaux et d’un ingénieur électrotechnicien, au niveau périphérique de : 5 unités régionale, qui assurent
une maintenance de proximité. La qualité du service est insuffisante dans la quasi-totalité des structures de maintenance
lié à la perception même de la composante maintenance, qui n’est généralement pas prise en compte lors de l’élaboration
Mauritius

16.52 65
Upper-Middle
8.9%
aged 30-70 yrs from 23.20% >10% (>25%) of
(1.8%)
income (%):i
Human Development
Years

34.4 (52)
rank:f
High-technology
ICT Development
5.9 (72) exports (% of 2.10%
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Equipment Committee under chairmanship of
Director of the Health Services.

Lists available: No Some lists are available for certain specific
conditions e.g pandemic, fogging, sprayers,
Unit: — etc. (an specific Plan is in preparation),
there are no specific lists for non-
Website: — comunicable nor communicable diseases.
Nomenclature systems used for devices and tests: — It must be pointed out that the Ministry
Lists available: No Some lists are available for certain specific
conditions e.g Pandemic, fogging,
Website: — sprayers, etc. There is no specific list for
Communicable Diseases but a PLAN is in
preparation.
e
—
Website(s): —

Name of regulatory agency: — Radiation Protection Authority for
Website(s): http://www.camec.mr/ Radiation.
Safety and Nuclear Security Authority (under the aegis of the Ministry of Energy
and Public Utilities).
Other agency’s website: https://rsnsa.govmu.org/Pages/default.aspx
220
WHO African Region
Mauritius
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified We import all our devices.
Website: —

Procurement Central Procurement Board has a
Policy or guideline: No Website: http://www.camec.mr/index.php/appels-d-offre policy. However, there is an equipment
National level procurement: No Website: — committee which looks after procurement
of equipment spare parts. For public
Donations sectorn procurement is done at a level
of the Ministry of Health and the central
Policy or guideline: No Website: — procurement board. Private equipment
Technical specifications is done by direct purchase. In the public
sector, we recommend certification
Technical specifications to support procurement or donations: Yes based on the FDA, CE and TUV approved
Publically available: No systems.
Website: —
Density per
population

Unit/Department: SSR National Hospital. Unit website: —
Contact name: Dr. Bissoondoyal Contact email: kbissoondoyal@mail.gov.mu
Type of inventories available: National inventory for medical equipment Each hospital has a separate inventory.
Concerning Software there is one
Website: — developed locally which is currently on
Use of management software: Yes Software name: Locally developed. trial. E-health is in preparation.

Contacts
Name: — Name: Dr. Laurent Musango
Email: — Email: musangol@who.int
Name: Dr. Bissoondoyal Name: —
Email: kbissoondoyal@mail.gov.mu Email: —
General comments (...Annex 1): Concerning the HT national police it is stated in following document: politique
santé.
Mexico

13.67 74
Upper-Middle
1.6%
aged 30-70 yrs from 15.60% >10% (>25%) of
(0.2%)
income (%):i
Human Development
0.78
Years

(0.61): 33.6 (55)
high
rank:f
High-technology
ICT Development
5.2 (87) exports (% of 20.40%
Index (rank):g

Website: https://www.gob.mx/cms/uploads/attachment/file/570535/PROGRAMA_Sectorial_de_Salud_2020-2024.pdf; https://www.
gob.mx/salud%7Ccenetec/articulos/compendio-de-normas-oficiales-mexicanas-relacionadas-con-infraestructura-y-equipamiento-
medico?idiom=es
Ministry of health responsible for health technology policy implementation: Centro Nacional de Excelencia Tecnológica en
Salud.

Lists available: Yes See “cuadro básico”. The list is under new
policies.
Unit: Consejo de Salubridad General.
Website: http://www.csg.gob.mx/index.html
http://www.csg.gob.mx/Compendio/CNIS/cnis.html
http://www.csg.gob.mx/contenidos/priorizacion/cuadro-basico.html
Nomenclature systems used for devices and tests: National.
(...Annex 1):
The lists are updated constantly.
Lists available: Yes
Website - hospitals: https://www.gob.mx/salud/acciones-y-programas/biblioteca-virtual-dgplades; www.gob.mx/cms/uploads/
attachment/file/35887/NOM-016-SSA3-2012.pdf
Website - laboratories: http://www.csg.gob.mx/descargas/pdf/priorizacion/cuadro-basico/aux_diag/catalogo/2017/EDICION_2017_
CByC-AUX_DE_DIAGNOST.pdf
Nomenclature systems used for devices and tests: Nationally developed.
Website: https://www.gob.mx/salud; https://www.gob.mx/salud/acciones-y-programas/
areas-de-la-subsecretaria-de-prevencion-de-la-salud; http://sinaiscap.salud.gob.mx:8080/
DGIS/; https://www.gob.mx/insabi/documentos/66-intervenciones?idiom=e
e
—
Unit/department: Centro Nacional de Excelencia Tecnológica en Salud.
Website(s): https://www.gob.mx/salud/cenetec; http://www.cenetec.salud.gob.mx/descargas/detes/ETES_GuiaEvalClinicaDM_16_
SPC_10_08_17.pdf; www.gob.mx/cms/uploads/attachment/file/293843/Guia_para_la_Evaluacion_Economica_de_Dispositivos_
Medicos.pdf
Contact: Dr. Esteban Hernández San Román Email: esteban.hernandez@salud.gob.mx

Name of regulatory agency: Comisión Federal para la Protección contra Riesgos —
Sanitarios (COFEPRIS).
Website(s): https://www.gob.mx/cofepris
Contact: Alejandro Ernesto Svarch Pérez Email: asvarch@cofepris.gob.mx
Name(s) of other regulatory agency eg. for radiation equipment etc.: Comisión Nacional de Seguridad Nuclear y
222 Salvaguardas.
Other agency’s website: https://www.gob.mx/cnsns; https://www.gob.mx/cofepris; https://www.gob.mx/ineel;
Mexico
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed The nomenclature system is established
and organized in charts for health
Use: For various purposes technologies that can be used in
Website: — public/social health services. As for the
government administration for 2018-
Medical device incorporation 2024, the charts will be organized as a
compendium and it is in the process of
Procurement depuration.
Policy or guideline: Yes Website: www.gob.mx/medico-e-instrumental-quirurgico-
enestablecimientos; www.gob.mx/salud/cenetec/acciones-y-programas/certificado-de- Medical device incorporation
necesidad-de-equipo-medico-278658; www.gob.mx/cms/uploads/attachment/file/601858/ comments (...Annex 1):
IB_Actualizacion_CDNEM_12dic2020.pdf; http://dof.gob.mx/5475093/2017; www.csg.gob. There are some recommendations for
this topic, but they are not policies. The
mx/GuiaBioeticaTriaje_30_Abril_2020_7pm.pdf specifications are only recomendations.
National level procurement: Yes Website: https://www.gob.mx/salud/cenetec/acciones-
y-programas/direccion-de-ingenieria-biomedica; https://www.gob.mx/salud/cenetec/
acciones-y-programas/certificado-de-necesidad-de-equipo-medico-278658; www.gob.mx/
IB_Actualizacion_CDNEM_12dic2020.pdf; http://dof.gob.mx/5475093&fecha=02/03/2017
Donations
Policy or guideline: Yes Website: https://www.dof.gob.mx/nota_detalle.php?codigo=5571017&fecha=02/09/2019
Website: www.gob.mx/salud/cenetec/acciones-y-programas/cedulas-de-especificaciones-tecnicas-para-equipo-medico
Density per
population


Unit/Department: Dirección de Ingeniería Biomédica. Unit website: https://www.gob.mx/salud/cenetec/acciones-y-programas/
direccion-de-ingenieria-biomedica; http://www.csg.gob.mx/contenidos/priorizacion/cuadro-basico/iyem/actualizaciones.html#
http://www.dgplades.salud.gob.mx/
Contact name: Dr. Oscar René Marrufo Melendez Contact email: oscar.marrufo@salud.gob.mx
Website with publically available technical specifications: www.gob.mx/salud/acciones-y-programas/cenetec-salud-cedulas-de-
especificaciones-tecnicas-de-equipo-medico; www.csg.gob.mx/contenidos/priorizacion/cuadro-basico/iyem/catalogos.html
Type of inventories available: Other Subsistema de Información de
Equipamiento, Recursos Humanos e
Website: http://sinaiscap.salud.gob.mx:8080/DGIS Infraestructura para la Atención a la
Use of management software: Yes Software name: There are not only one, in Salud (Subsystem of Equipment, Human
Resources and Infraestructure in Health).
general these are made in each one of the units for their particular needs. There are not only one, in general these
are made in each one of the units for their
Medical devices workforce particular needs.
Contacts
Name: Mtra. Dafne Ruiz Vargas Name: Dr. Miguel Malo Serrano
Email: dafne.ruiz@salud.gob.mx Email: malom@paho.org

Micronesia (Federated States of)

24.65 48
Lower-Middle
aged 30-70 yrs from 46.30% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Lists available: No There are no lists available.
Website: —
e
The unit of Budget and Planning with the
HTA unit/department includes the assessment of medical devices: No department of finance and administration
Unit/department: — (DOFA) performs economic analysis,
however, there is no HTA for medical
Website(s): — products.

Website(s): —
224
Micronesia (Federated States of)

Website: —

Procurement Medical devices may be purchased by the
Policy or guideline: No Website: — National Department of Health & Social
Affairs, or the State Health Services. At
National level procurement: No Website: — a national level purchases are made by
Donations the coordinator of the program receving
the grant or funds for the purchase in
Policy or guideline: No Website: — consultation with the department to
receive the device (e.g. manager of state
Technical specifications hospital radiography department, or
Technical specifications to support procurement or donations: No chief of ancillary services). Guidelines are
only for competitive quotes or bidding
Publically available: — processes.
Website: —
Density per
population
Mammograph:α,* 0 0
Radiotherapy:β 0 0

Type of inventories available: National inventory for medical equipment The National Department of Health and
Social Affairs, as well as state health
Website: — services, keep assets registries for fixed
Use of management software: No Software name: — assets over $1,000. Medical Devices will
be included on these registers. Individual
units (e.g. state laboratory) should have a
functional inventory of devices/equipment.
Contacts
Name: Ms. Lisa Barrow Kohler Name: Dr. Momoe Takeuchi
Email: lbarrow@fsmhealth.fm Email: takeuchim@who.int
Name: Mr. Andy Wilson Name: —
Email: awilson@fsmhealth.fm Email: —
General comments (...Annex 1): There is limited expertise in the country. There are no qualified radiographers nor
pathologists. Only 3 over 30 laboratory technicians have a bachelors degree in medical laboratory science.
Monaco

3.02 85
High
aged 30-70 yrs from — >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—): — (—)
rank:f
High-technology
ICT Development
8.1 (19) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Lists available: No There are “Plans d’urgence”.
Website: —
e
La Direction de l’Action Sanitaire pourrait
HTA unit/department includes the assessment of medical devices: No commander évaluations des technologies
Unit/department: — de Santé.
Website(s): https://www.gouv.mc/Gouvernement-et-Institutions/Le-Gouvernement/
Departement-des-Affaires-Sociales-et-de-la-Sante/Direction-de-l-Action-Sanitaire

Name of regulatory agency: Direction de l’Action Sanitaire et Sociale. —
Website(s): https://www.gouv.mc/Gouvernement-et-Institutions/Le-Gouvernement/
Departement-des-Affaires-Sociales-et-de-la-Sante/Direction-de-l-Action-Sanitaire
Contact: Ms. Anne Negre Email: dass@gouv.mc
226
WHO European Region
Monaco
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed Directive 93/42/CEE.
Use: For regulatory purposes
Website: https://www.gouv.mc/Gouvernement-et-Institutions/Le-Gouvernement/
Departement-des-Affaires-Sociales-et-de-la-Sante/Direction-de-l-Action-et-de-l-Aide-
Sociales

Procurement
Donations Procurement guidelines: marquage CE
Policy or guideline: Yes Website: — requis.
Website: —
Density per
population

Unit/Department: Département des Affaires Sociales et de la Santé. Unit website: —
Contact name: Ms. Anne Eastwood. Contact email: aeastwood@gouv.mc
Type of inventories available: None Pas d’inventaire.
Website: —

Contacts
Name: Ms. Anne Negre Name: —
Email: dass@gouv.mc Email: —
Name: Ms. Anne Eastwood. Name: —
Email: aeastwood@gouv.mc Email: —
Mongolia

15.37 63
Lower-Middle
2.4%
aged 30-70 yrs from 35.00% >10% (>25%) of
(0.5%)
income (%):i
Human Development
0.74
Years

(0.63): 33.4 (58)
high
rank:f
High-technology
ICT Development
5 (91) exports (% of 18.90%
Index (rank):g

Website: —
Language(s): Mongolian
Ministry of health responsible for health technology policy implementation: Department of Strategic Policy and Planning.

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): —
228
Mongolia
Website: —

Procurement
Donations —
Website: —
Density per
population

Website: —

Contacts
Name: Ms. Bulgansuren Name: Dr. Sergey Diorditsa
Email: bulgan_21@yahoo.com Email: diorditsas@who.int
Name: — Name: —
Montenegro

2.39 67
Upper-Middle
10.3%
aged 30-70 yrs from 22.30% >10% (>25%) of
(0.8%)
income (%):i
Human Development
0.83
Years

(0.75): 35.4 (49)
very high
rank:f
High-technology
ICT Development
6.4 (61) exports (% of 3.20%
Index (rank):g

Website: http://www.mzdravlja.gov.me/rubrike/strategija-razvoja-zdravstva-crne-gore/97487/MASTER-PLAN-RAZVOJA-ZDRAVSTVA-
CRNE-GORE-ZA-PERIOD-2010-2013.html
Language(s): Montenegrin
Ministry of health responsible for health technology policy implementation: Unit for Management in Health Care.

Lists available: Yes There is a list of medical devices (based
on the opinion of a team of doctors)
Unit: Health Insurance Fond. that are provided or reimbursed to the
patient by the Health Insurance Fond.
Website: http://www.mup.gov.me/biblioteka/strategije The list is created as a result of different
Nomenclature systems used for devices and tests: — indications mostly for treatment,
Website - hospitals: https://mzdravlja.gov.me/ministarstvo
Website - laboratories: https://www.cinmed.me/Portal/faces/PretragaS?_adf.ctrl-
state=feepi92qs_4&_afrLoop=7290369444662547
National list for specific clinical interventions/emergencies: There are no national standards for
Lists available: No medical devices, but Competent Authority,
Website: http://www.mup.gov.me/biblioteka/strategije in accordance with the law on medical
devices recognize appropriate international
standards (EC, ISO). There is the Law
e
National health technology assessment unit on Protection of Population against
There is no HTA framework yet, but
HTA unit/department includes the assessment of medical devices: No positive political will.
Website(s): https://www.cinmed.me/Portal/faces/dinamickeStrane?_afrLoop=
7024818723742526&paramPut=Legislation++%3E++Instructions&paramRender=2&param
S=96&_adf.ctrl-state=3rt6t7bsn_177

Name of regulatory agency: Agency for Medicines and Medical Devices of —
Montenegro, Department for medical devices.
Website(s): https://www.cinmed.me/Portal/faces/dinamickeStrane?_adf.ctrl-
state=1720yojvsi_112; http://calims.me/Portal/faces/glavna.jspx?_afrWindowMode=0&_
afrLoop=18093784927814901&_adf.ctrl-state=17pyrlqel8_92
Contact: Ms. Erna Sehovic Email: erna.sehovic@calims.me
Name(s) of other regulatory agency eg. for radiation equipment etc.: Environmental Protection Agency of Montenegro.
230
WHO European Region
Montenegro
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed “Register (notification) of medical
Use: For regulatory purposes devices” that contains information on
medical devices which are available
Website: https://www.calims.me/Portal/Definitions+ for use in Montenegro has just recently
and+Classification&paramRender=2&paramS=70&_adf.ctrl-state=wn7tyvskh_894 been set up. As it is at the start of its
operations, it will use GMDN as a referent

nomenclature system and based on this,
it will be developed a system that will
be in Montenegrin language so that all
Procurement users can use it properly and they will
Policy or guideline: Yes Website: https://www.calims.me/
Portal/&putanja=Law+on+amendments +to+the+Law+on+medical+devices_2009.pdf Medical device incorporation
https://www.calims.me/Portal//Fees_medical+devices_CALIMS_2009.pdf https://www. comments (...Annex 1):
calims.me/Portal/faces/Zakon+o+medicinskim+sredstvima.pdf The procurements of medical devices for
public health institutions are in conformity
National level procurement: Yes Website: https://www.calims.me/Portal/ with Law on public procurements. We
medical+device+in+the+register+of+medical+devices.pdf&; https://www.calims. recognize international standards in
me/Portal/medical+devices+-+May+2018.pdf; https://www.calims.me/Portal/faces/ accordance with a law on medical devices.
manufacturers+into+the+register.pdf&_adf.ctrl-state=wn7tyvskh_496
Donations
Website: https://www.calims.me/Portal/faces/Guidelines&paramRender=null&paramS=99&_adf.ctrl-state=wn7tyvskh_360
Density per
population

Unit/Department: Healh Insurance Fond. Unit website: https://fzocg.me/page.php?type=novost&id=320
Website with publically available technical specifications: https://fzocg.me/Administracija/Documents/1589285931Politika%20
sistema%20upravljanja%20kvalitetom%20i%20sigurnosti%20informacija.pdf
Type of inventories available: National inventory only for high cost technologyes There are no specific national inventories
but every year the Government of
(such as MRI, CT, or PET scanners) Montenegro provides a specific amount of
Website: — money that can be used in special cases
(public health emergency etc.).

Contacts
Name: Ms. Erna Sehovic Name: Ms. Mina Brajovic
Email: erna.sehovic@calims.me Email: brajovicm@who.int
Name: Ms. Majda Sahman
Email: majda.sahman@calims.me
General comments (...Annex 1): Concerning the Infrastructure section: We would like to inform you that we have
specialized hospitals for only one speciality as psychiatric, orthopaedic and lungs diseases. We have 3 institutions like this.
Morocco

18.69 73
Lower-Middle
aged 30-70 yrs from 24.10% >10% (>25%) of — (—)
income (%):i
Human Development
Years

29 (75)
rank:f
High-technology
ICT Development
4.8 (100) exports (% of 4.90%
Index (rank):g

Website: —
Ministry of health responsible for health technology policy implementation: Department of Equipe Medicale (DEM) within
MoH.

Lists available: Yes, but it is only a recommendation Des listes standardisées de dispositifs
médicaux pour différents établissements
Unit: — de soins sont établies au niveau de la DEM.
Website: —
Lists available: — Concernant les points “b” et “c” des listes
sont établies au niveau de la DEM. La
Website: — DELM prend en charge les points “a” et “b”
aussi (see comments of other lists).
e
Adopted EMA (European Medicines
HTA unit/department includes the assessment of medical devices: No Agency) and ICH (International Council
Unit/department: — for Harmonisation for Pharmaceuticals)
Website(s): — performs health economics HTA. Within
Contact: — Email: — the MoH, HTA is focused on pharmaceutics
but not in medical devices.

Name of regulatory agency: Ministère de la Santé. —
Website(s): https://www.sante.gov.ma/
Safety and Nuclear Security Authority (Ministry of Energy and Public Utilities)and
Moroccan Agency for Nuclear and Radiological Safety and Security (AMSSNuR).
Other agency’s website: https://amssnur.org.ma/; http://dmp.sante.gov.ma/
232
Morocco
C3D4 Official nomenclature system for medical devices: Yes Type: Based on UMDNS Use: Nomenclature basée sur l’ECRI et le CNEH.
Not specified
Website: —

Procurement
Donations Un projet de mise en place d’une stratégie
Policy or guideline: No Website: — Nationale en matière de gestion des T.S
est en cours. Les spécifications techniques
Technical specifications sont établies selon les besoins des
Technical specifications to support procurement or donations: Yes utilisateurs (grands projets de CHUs)
et standardisées pour chaque type
Publically available: No d’établissement de soins.
Website: —
Density per
population

Type of inventories available: National inventory for medical equipment La majorité des inventaires des régions
sont sur support papier et non encore
Website: — informatisé. L’alimentation de la base
Use of management software: Yes Software name: Up Manager Praxis. de données du progiciel de gestion des
dispositifs médicaux est en cours.

Contacts
Name: Ms. Nadia Gaagouch Name: Ms. Maryam Bigdeli
Email: nadia.gaagouch@gmail.com Email: BigdeliM@who.int
Name: — Name: —
Mozambique

70.55 47
Low
1.6%
aged 30-70 yrs from 30.60% >10% (>25%) of
(0.4%)
income (%):i
Human Development
0.46
Years

(0.32): 18.7 (124)
low
rank:f
High-technology
ICT Development
2.3 (150) exports (% of 5.60%
Index (rank):g

Website: —
Language(s): Portuguese
Ministry of health responsible for health technology policy implementation: Direcção Nacional Assistência Médica.

Unit: —
Website: —
Website: —
e
The Department of Health Information
HTA unit/department includes the assessment of medical devices: No (DIS), Ministry of Health (MISAU), performs
Unit/department: No HTA for technologies related to prevention
and control of diseases, but no specifically
Website(s): — for medical devices.

Name of regulatory agency: Direction des Equipements et de la Maintenance, —
Ministère de la Santé.
Website(s): —
Atomic Energy Agency of Mozambique and the International Atomic Energy Agency (IAEA).
Other agency’s website: https://www.iaea.org/newscenter/news/iaea-advises-mozambique-on-strengthening-regulatory-
infrastructure
234
WHO African Region
Mozambique
Use: Not specified
Website: —

Procurement
Donations —
Website: —
Density per
population

Unit/Department: Centro de Abastecimiento. Unit website: —
Contact name: Dr. Ernesto Mazivilla Contact email: —
Website: —
Use of management software: Yes Software name: Simorganizer.

Contacts
Name: Mr. Amisse Momade Name: Dr. Severin Ritter Von Xylander
Email: amisse.momade@gmail.com Email: xylanders@who.int
Name: Dr. Ernesto Mazivilla Name: Dr. Ana Fernandes
Email: alessandro.campione@gmail.com Email: fernandesa@who.int
Myanmar

43.65 61
Lower-Middle
14.4%
aged 30-70 yrs from 24.90% >10% (>25%) of
(2.8%)
income (%):i
Human Development
Years

17.7 (129)
rank:f
High-technology
ICT Development
3 (135) exports (% of 2.80%
Index (rank):g

Website: www.mohs.gov.mm
Language(s): Myanmar and English
Ministry of health responsible for health technology policy implementation: Department of Food and Drug Administration,
Department of Medical Services.

Unit: —
Website: —
Website: —
e
It has started the development of HTA
HTA unit/department includes the assessment of medical devices: Yes systems by establishing nodal agencies
Unit/department: Department of Food and Drug Administration, Department of and conducting ad-hoc activities.
Medical services.
Website(s): www.mohs.gov.mm

Name of regulatory agency: Department of Food and Drug Administration. —
Website(s): https://www.mohs.gov.mm/
http://www.fdamyanmar.gov.mm/
https://www.fda.gov.mm/?s=medical+devices
Contact: Dr. NweOo Email: drnweoo1980@gmail.com
Name(s) of other regulatory agency eg. for radiation equipment etc.: Food and
Drug Administration, Myanmar (Medical devices); Association of Southeast Asian Nations (ASEAN).
Other agency’s website: https://www.fda.gov.mm/?s=medical+devices
236
Myanmar
Website: —

Procurement
Policy or guideline: Yes Website: www.mohs.gov.mm
Donations The Procurement and Distribution Division,
Policy or guideline: Yes Website: — Department of Medical Services is in
charge of procurement at a national level.
Website: —
Density per
population

Unit/Department: Department of Medical Services. Unit website: www.mohs.gov.mm
Type of inventories available: National inventory for medical equipment In some cases, there is an inventory only
for high cost technologies (such as MRI, CT
Website: — or PET scanners).

Contacts
Name: Dr. NweOo Name: Dr. Stephan Paul Jost
Email: drnweoo1980@gmail.com Email: josts@who.int
Name: Dr. Soe Aung Name: Dr Thushara Eraj Indranath Fernando
Email: drsoeaung@gmail.com Email: fernandot@who.int
Namibia

40.16 62
Upper-Middle
aged 30-70 yrs from 22.60% >10% (>25%) of — (—)
income (%):i
Human Development
0.65
Years

(0.42): 22.5 (104)
medium
rank:f
High-technology
ICT Development
3.9 (118) exports (% of 0.20%
Index (rank):g

Website: https://mhss.gov.na/home
https://mhss.gov.na/procurement
Ministry of health responsible for health technology policy implementation: Directorate of Tertiary Health Care & Clinical
Support Services (THC & CSS).

Unit: —
Website: —
Website: —
e
MoH uses HTA for both regulatory and
HTA unit/department includes the assessment of medical devices: No coverage purposes. Not performed for
Unit/department: — medical devices. However, an HTA has
yet to be elevated to the national agenda.
Website(s): https://mhss.gov.na/ There is a written HTA. guideline, and
Contact: — Email: — formal identification of technologies for
HTA.

Name of regulatory agency: Namibia Medicines Regulatory Council. According to the Atomic Energy and
Website(s): https://nmrc.gov.na/ Radiation Protection Act No. 5 of 2005.
Contact: Mr. Axel Tibinyane Email: atibinyane@mhss.gov.na
Name(s) of other regulatory agency eg. for radiation equipment etc.: Directorate of
Atomic Energy & Radiation Protection Authority.
Other agency’s website: https://mhss.gov.na/home
238
WHO African Region
Namibia
Website: —

Procurement Medical device incorporation
Policy or guideline: Yes Website: https://mhss.gov.na/procurement-act comments (...Annex 1):
There are guidelines for Implementation of
National level procurement: Yes Website: — the National Health care Technology Policy
Donations & Medical Equipment Management. Since
finances have been decentralised, each
Policy or guideline: Yes Website: https://mhss.gov.na/ of the 13 political regions is responsible
for budgeting and procuring medical
Technical specifications equipment for the health facilities in that
Technical specifications to support procurement or donations: No region. Advise on budgeting and tender
specifications can be obtained from MEM
Publically available: — at a National Level.
Website: —
Density per
population

Unit/Department: Atomic Energy & Radiation Protection. Unit website: —
Contact name: Mr. A. Tibinyane Contact email: atibinyane@mhss.gov.na
Type of inventories available: National inventory for medical equipment Medical Equipment Management System
Software (MEMS).
Website: —
Use of management software: Yes Software name: Medical Equipment
Management System Software (MEMS).

Contacts
Name: Ms. Belinda Woelbling Name: Dr. Charles Sagoe-Moses
Email: bwolbling@mhss.gov.na Email: sagoemosesc@who.int
Name: Mr. A. Tibinyane Name: —
Email: atibinyane@mhss.gov.na Email: —
Nauru

28.49 54
High
aged 30-70 yrs from — >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—): — (—)
rank:f
High-technology
ICT Development
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Lists available: No SPC assist us with our supplies for the
Pandemic preparedness but we do
Website: — not have a list as most of these are
consumables.
e
—
Website(s): —

Website(s): —
240
Nauru
Website: —

Procurement
Donations The procurement for the medical
Policy or guideline: No Website: — devices is based on the Hospital’s Senior
Management Team decision and the
Technical specifications availability of the fund.
Website: —
Density per
population


Type of inventories available: National inventory for medical equipment We keep an asset register at the
Administration Office and the
Website: — Pharmaceutical Store which include all the
Use of management software: No Software name: — medical equipment in the hospital.

Contacts
Name: Dr. Alani Tangitau Name: Dr. Mark Andrew Jacobs
Email: alani.tangitau@nauru.gov.nr Email: jacobsma@who.int
Name: Mr. Jiosese Mailulu Name: Dr. Subhash Yadav
Email: jiosese.mailulu@nauru.gov.nr Email: syadav@who.int
Nepal

28.16 53
Lower-Middle
10.7%
aged 30-70 yrs from 21.50% >10% (>25%) of
(2.4%)
income (%):i
Human Development
Years

24.4 (95)
rank:f
High-technology
ICT Development
2.9 (140) exports (% of 1.20%
Index (rank):g

Website: https://mohp.gov.np/uploads/Resources/1657873750667Health-Care-Technology-Policy.pdf
https://www.dda.gov.np/content/health-technology-product-an-medical-device-directive-2074

Unit: —
Website: http://182.93.95.152/tsb/
Website: —
e
HTA unit/department includes the assessment of medical devices: No not national unit per se. However, there is
Unit/department: — research in the health unit within the MoH.
The HTA under the government umbrella is
Website(s): — in progress and a requirement to reach the
Contact: — Email: — Universal Health Care country goal.

Name of regulatory agency: Department of Health Services and Logistics —
Management Division.
Website(s): https://www.dda.gov.np/content/role-of-dda
Contact: Dr. Mingmar G. Sherpa Email: doctor_mingma@hotmail.com
Health and Population (MoHP).
Other agency’s website: https://mohp.gov.np/en
242
Nepal
C3D4 Official nomenclature system for medical devices: No —
Type: More than one system Use: For various purposes
Website: —

Procurement
Donations We follow the Public Procurement Act and
Policy or guideline: No Website: — the regulation of Nepal for procurement
of medical devices also. Also, it is partially
Technical specifications carried out at national level procurement
Technical specifications to support procurement or donations: No of medical devices.
Website: —
Density per
population

Unit/Department: Logistic Management Section – Department of Health Services Unit website: https://dohs.gov.np/logistic-
management-section/
Contact name: Dr. Mingmar G. Sherpa Contact email: doctor_mingma@hotmail.com
Website with publically available technical specifications: http://182.93.95.152/tsb/
Type of inventories available: None Working on to develop national
inventories.
Website: —
Use of management software: Yes Software name: Web-based LMIS web based
equipment/instrument, Inventory Management System.

Contacts
Name: Dr. Mingmar G. Sherpa Name: Dr. Rajesh Pandav
Email: doctor_mingma@hotmail.com Email: pandavr@who.int
Name: — Name: —
Netherlands

4.16 86
High
aged 30-70 yrs from 10.40% >10% (>25%) of — (—)
income (%):i
Human Development
0.94
Years

(0.88): 58.8 (5)
very high
rank:f
High-technology
ICT Development
8.5 (7) exports (% of 23.10%
Index (rank):g

Website: https://www.rijksoverheid.nl/documenten/kamerstukken/2019/04/26/kamerbrief-over-visie-op-medische-technologie
https://www.government.nl/topics/health-insurance/documents/leaflets/2016/02/09/healthcare-in-the-netherlands
https://www.rivm.nl/en/medical-devices
https://www.eerstekamer.nl/wetsvoorstel/35043_wet_medische_hulpmiddelen
Language(s): Dutch
Ministry of health responsible for health technology policy implementation: Department Pharmaceutical Affairs and
Medical Technology.

Lists available: No The health insurance scheme takes care
of the reimbursement of extramural
Unit: Department of Pharmaceutical Affairs and Medical Technology. medical devices in the Netherlands. The
reimbursement of medical devices is
Website: https://english.igj.nl/medical-technology/market-authorisation/registration-and- function orientated.
deregistration
Website - hospitals: https://www.eerstekamer.nl/eu/documenteu/2017/745_verordening_
van_het_europees/f=/vkxleq2mblth.pdf
Website - laboratories: https://www.eerstekamer.nl/eu/documenteu/2017/746_
verordening_betreffende/f=/vkxlera1orfl.pdf
Lists available: No In the Netherlands, the professional has to
decide, recommend or indicate a medical
Website: — device. The cupola of the professionals can
publish a guideline for specific procedures.
There is no national policy on diseases or
e
National health technology assessment unit situations.
—
Unit/department: Zorginstituut.
Website(s): http://www.zorginstituutnederland.nl/

Name of regulatory agency: Ministry of Health, Welfare and Sport, Department of For vigilance and post market surveillance
Pharmaceutical Affairs and Medical Technology. (more info in the medische-hulpmiddelen
Website(s): https://www.rijksoverheid.nl/onderwerpen/medische-hulpmiddelen corresponding link).
Contact: Mr. Jan van Ginneken Email: j.v.ginneken@minvws.nl

Name(s) of other regulatory agency eg. for radiation equipment etc.: Dutch
Healthcare Inspectorate; Authority for Nuclear Safety and Radiation Protection (ANVS).
244 Other agency’s website: https://english.igj.nl/; www.anvs.nl
WHO European Region
Netherlands
Donations There is the Commission decision of 7 May
Policy or guideline: No Website: — 2002 on common technical specifications
for in vitro-diagnostic medical devices.
Website: http://eur-lex.europa.eu/LexUriServ/LexUriServ.
do?uri=OJ:L:2002:131:0017:0030:nl:PDF
Density per
population


Unit/Department: Health Care Insurance Board (CVZ). Unit website: http://www.gipdatabank.nl/
http://www.cvz.nl/
Contact name: Mr. J. A. C. van Ginneken Contact email: j.v.ginneken@minvws.nl
Website with publically available technical specifications: https://www.eerstekamer.nl/id/vhyxhx1knmz8/document_extern/
w31469eg/f=/w31469eg.pdf
https://eur-lex.europa.eu/legal-content/NL/TXT/PDF/?uri=CELEX%3A32017R0746&from=EN
Type of inventories available: None The Netherlands has no national inventory
for medical devices.
Website: —

Contacts
Name: Mr. Jan van Ginneken Name: —
Email: j.v.ginneken@minvws.nl Email: —
Name: Mr. J. A. C. van Ginneken Name: —
Email: j.v.ginneken@minvws.nl Email: —
New Zealand

4.72 86
High
aged 30-70 yrs from 10.30% >10% (>25%) of — (—)
income (%):i
Human Development
0.93
Years

(0.86): 47 (26)
very high
rank:f
High-technology
ICT Development
8.3 (13) exports (% of 9.90%
Index (rank):g

Website: —
Language(s): —
National lists of medical devices Approved devices lists comments

National list of approved priority/essential medical devices, (...Annex 1):
Under New Zealand law there is no
(including IVDs), for procurement or reimbursement: approval system for medical devices and
Lists available: No hence no pre-market scrutiny of their
safety and performance. There is a legal
Unit: — requirement for the sponsor (importer/
Website: — exporter/supplier) of a medical device
(with some exceptions) to notify the
Nomenclature systems used for devices and tests: — device to a database maintained by
Website: —
e
National Health Committee performs
HTA unit/department includes the assessment of medical devices: No HTA in several areas, but not for medical
Unit/department: — devices.
Website(s): —

Name of regulatory agency: The Medicines and Medical Devices Safety Authority —
(Medsafe), a business unit of the Ministry of Health.
Website(s): https://www.medsafe.govt.nz/regulatory/DevicesNew/3-2Explanation.asp
Contact: Ms. Susan Martindale Email: susan_martindale@moh.govt.nz
Name(s) of other regulatory agency eg. for radiation equipment etc.: Medicines and
Medical Device Safety Authority (MedSafe).
Other agency’s website: http://www.medsafe.govt.nz/
246
New Zealand
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN —
Use: Not specified
Website: —

Procurement
Donations National requirements apply only to
Policy or guideline: No Website: — procurement of electro-medical devices
through a set of AS/NZ standards such
Technical specifications as AS/NZ3551:2004 which are mandated
Technical specifications to support procurement or donations: No under a national law. Government
publishes standards that are applicable to
Publically available: — some devices.
Website: —
Density per
population

Website: —
Use of management software: Yes Software name: Hardcat, Tektrak and Beims.

Contacts
Name: — Name: Dr. Corinne Reisinger Capuano
Email: — Email: CapuanoC@who.int
Name: — Name: —
General comments (...Annex 1): The definition of medical device used in NZ law (the Medicines Act 1981) is not
currently aligned with the GHTF approach. Consequently, some products that are regarded as devices in other countries
are currently regulated as medicines in NZ. Examples include pregnancy tests, condoms with spermicide, IUCDs with
copper and nasal irrigation solutions.
Nicaragua

16.04 70
Lower-Middle
14.8%
aged 30-70 yrs from 15.30% >10% (>25%) of
(3.0%)
income (%):i
Human Development
0.66
Years

(0.51): — (—)
medium
rank:f
High-technology
ICT Development
3.3 (130) exports (% of 1.10%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: http://www.minsa.gob.ni/index.php/repository/Descargas-MINSA/
Direcci%C3%B3n-General-de-Regulaci%C3%B3n-Sanitaria/Dispositivos-M%C3%A9dicos/
repository
Website - hospitals: http://www.minsa.gob.ni/
Website - laboratories: http://www.minsa.gob.ni/index.php/repository/func-
download/399/chk,be041b94ed602d617d517851511ca3b7/no_html,1/
http://www.minsa.gob.ni/index.php/repository/Descargas-MINSA/Divisi%C3%B3n-General-
de-Insumos-M%C3%A9dicos/Lista-B%C3%A1sica-de-Insumos/Lista-B%C3%A1sica-de-Insumos-de-Laboratorios/
Lists available: Yes The Ministry of Health does not have lists
recommending health technology for
Website: http://www.minsa.gob.ni/index.php/repository/func-download/359/ different diseases or situations.
chk,850a55c3bca951031a3dc35ab94264a6/no_html,1/
e
Website(s): —

Name of regulatory agency: Dirección General de Regulación Sanitaria. —
Website(s): http://www.minsa.gob.ni/index.php/repository/Descargas-MINSA/
Direcci%C3%B3n-General-de-Regulaci%C3%B3n-Sanitaria/Dispositivos-M%C3%A9dicos/
repository
Contact: Lic. Luz María Torrez Email: dgrs@minsa.gob.ni
248
Nicaragua
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: For various reasons, there is not an official
For regulatory purposes nomenclature system used for medical
devices.
Website: —

Procurement
National level procurement: Yes Website: http://www.minsa.gob.ni/index.php/
repository/Descargas-MINSA/Divisi%C3%B3n-de-Adquisiciones/Normativas-y-Funciones/
The procurement department works as a
repository team with the Health Services Department,
Donations the Sanitary Regulations Department
and the Acquisition Unit of the Ministry of
Policy or guideline: Yes Website: http://www.minsa.gob.ni Health.
Website: —
Density per
population

Unit/Department: Dirección General de Regulación Sanitaria. Unit website: http://www.minsa.gob.ni
Contact name: Lic. Luz María Torrez Contact email: dgrs@minsa.gob.ni
Website with publically available technical specifications: http://www.minsa.gob.ni/index.php/repository/Descargas-MINSA/
Direcci%C3%B3n-General-de-Regulaci%C3%B3n-Sanitaria/Dispositivos-M%C3%A9dicos/Normativa-064%E2%80%9CNorma-para-el-
registro-de-dispositivos-m%C3%A9dicos%E2%80%9D/
Type of inventories available: National inventory for medical equipment This inventory was carried out for the
maintenance unit (CEMED). The last
Website: — update was in 2009.

Contacts
Name: Ms. Tatiana Valdez García Name: Ing. Ana Solis-Ortega Treasure
Email: didt01@minsa.gob.ni Email: treasurea@paho.org
Name: Lic. Luz María Torrez Name: Dr. Alexandre Florencio
Email: dgrs@minsa.gob.ni Email: florencioa@paho.org
General comments (...Annex 1): Our Ministry of

Health is doing big efforts to normalize and regulate the procurement of medical devices, but we do require training for
our personnel to perform a better job. We also have limitations in providing maintenance to the acquired equipment.
Niger

77.52 37
Low
6.6%
aged 30-70 yrs from 21.00% >10% (>25%) of
(1.9%)
income (%):i
Human Development
0.39
Years

(0.28): 17.8 (128)
low
rank:f
High-technology
ICT Development
— (—) exports (% of 3.00%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website - hospitals: https://hfr.health.gov.ng/resources
https://hfr.health.gov.ng
Website - laboratories: https://www.health.gov.ng/index.php?option=com_
content&view=article&id=130&Itemid=496
Website: —
e
—
Website(s): —

Website(s): —
250
WHO African Region
Niger
C3D4 Official nomenclature system for medical devices: No Il ya plusieurs types de codification testés.
Type: More than one system Use: Not specified Les premières se sont inspirées du code
CNEH (code national pour l’équipement
Website: — hospitalier) français. Il n’ya pas de
codification unique retenue au niveau
national.
Procurement
Donations Toutes les acquisitions réalisées dans le
Policy or guideline: No Website: — cadre des projets et programmes passent
par la DIES. Mais certaines (ONG et
Technical specifications associations caritaives) ne passent pas.
Website: —
Density per
population
Radiotherapy:β 0 0

Unit/Department: Direction des Infrastructures et Equipements Sanitaires. Unit website: —
Contact name: Mr. Moumouni Alhassane Contact email: kouubii@yahoo.fr
Type of inventories available: National inventory for medical equipment Il ya eu plusieurs tentatives d’installation
de logiciel de GMAO (Gestion de la
Website: — Maintenance Assistée par Ordinateur) dont
Use of management software: No Software name: — Gestmat (par la Société Deloitte et Touch
Consulting) et OPTIM (par le Bureau BEEM
Engineering France). Aucun logiciel n’est
totalement fonctionnel en ce moment.
Contacts
Name: Ms. Maman Kiassa Adamou Name: Dr. Blanche-Philomene Melanga Anya
Email: kiassas@yahoo.fr Email: anyab@who.int
Name: Mr. Moumouni Alhassane Name: —
Email: kouubii@yahoo.fr Email: —
General comments (...Annex 1): Le Niger dispose d’une stratégie nationale de maintenance adoptée depuis avril
2008.
Nigeria

113.77 44
Lower-Middle
15.1%
aged 30-70 yrs from 16.90% >10% (>25%) of
(4.1%)
income (%):i
Human Development
0.54
Years

(0.35): 20.1 (117)
low
rank:f
High-technology
ICT Development
2.6 (143) exports (% of 1.50%
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Food and Drug Services.

Unit: —
Website: —
Website: —
e
Three organisms perform HTA at a national
HTA unit/department includes the assessment of medical devices: Yes level: The Agency for Food and Drugs
Unit/department: Nigeria Institute for Pharmaceutical Research and Administration and Control (NAFDAC),
Nigeria Institute for Pharmaceutical
Development (NIPRD). Research and Development (NIPRD) and
Website(s): https://www.niprd.gov.ng/ the National Health Insurance Scheme.
https://www.nhis.gov.ng/ (NHIS). The action plan 2018-2021 of the
MoH states the progress to a National
https://www.nafdac.gov.ng/ Quality Review & Health Technology
https://health.gov.ng/doc/NSHDP%20II%20Final.pdf Assessment Systems to determine which
health interventions are cost effective
Contact: — Email: information.niprd@niprd.gov.ng including medical devices (see fourth link).
Committee includes a biomedical or clinical engineer: — HTA is a pliar for UHC’s goal.

Name of regulatory agency: National Agency for Food and Drug Administration and —
Control.
Website(s): http://www.nafdac.gov.ng/
Contact: Dr. Chinyere Ilonze Email: —
Agency for Food and Drug Administration and Control (NAFDAC).
Other agency’s website: http://www.nafdac.gov.ng/products/medicalsmenu
252
WHO African Region
Nigeria
Website: —

Procurement
Donations —
Website: —
Density per
population

Unit/Department: Medical Devices Management and Standardization Unit. Unit website: —
Contact name: Mr. Esan Bukola Emmanuel Contact email: bukolaesan2000@yahoo.com
Website: —

Contacts
Name: Mr. Esan Bukola Emmanuel Name: Dr. Walter Kazadi Mulombo
Email: bukolaesan2000@yahoo.com Email: kazadimulombow@who.int
Name: — Name: —
Niue

24.8 55
—
aged 30-70 yrs from — >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—): — (—)
rank:f
High-technology
ICT Development
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): —
254
Niue
Website: —

Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: — Name: —
North Macedonia

5.93 68
Upper-Middle
aged 30-70 yrs from 22.70% >10% (>25%) of — (—)
income (%):i
Human Development
0.77
Years

(0.68): 33.4 (57)
high
rank:f
High-technology
ICT Development
6 (69) exports (% of 4.20%
Index (rank):g

Website: —
Language(s): —

Lists available: No The reimbursement is performed by the
National Health Insurance Fund, the list
Unit: — of medical devices that are reimbursed
are posted on the “fzo website”. In
Website: www.fzo.org.mk public health facilities the procurement
Nomenclature systems used for devices and tests: — is currently going through a public
Website: —
e
There is not an HTA national unit yet per se
HTA unit/department includes the assessment of medical devices: No but it has been acknowledged at a political
Unit/department: — level by the MoH. There are HTA activities
for the selection of specific medicines. It
Website(s): — exists a Centralized System for external
Contact: — Email: — price referencing and decentralized
procurement prices of non-prescription
Committee includes a biomedical or clinical engineer: — medicines and devices.

Name of regulatory agency: Bureau of Drugs, Ministry of health is responsible for —
implementing the regulations for medical devices.
Website(s): www.zdravstvo.gov.mk
Contact: Ms. Katerina Aleksoska Email: katerina.aleksoska@zdravstvo.gov.mk
Safety Directorate.
Other agency’s website: https://www.iaea.org/sites/default/files/fyrm_nr-7th-rm.pdf
256
WHO European Region
Nor th Macedonia
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified The GMDN code is being recognized.
Website: —

Procurement
Donations —
Website: —
Density per
population

Website: —

Contacts
Name: — Name: —
Name: — Name: —
Norway

2.2 86
High
aged 30-70 yrs from 8.70% >10% (>25%) of — (—)
income (%):i
Human Development
Years

49.3 (20)
rank:f
High-technology
ICT Development
8.5 (8) exports (% of 22.60%
Index (rank):g

Website: https://www.regjeringen.no/no/dokumenter/meld-st-10-20122013/id709025/
Language(s): —
Ministry of health responsible for health technology policy implementation: The Department of Specialiced Health Care
Services.

Lists available: Yes A few devices - those being reimbursed
via the blue prescription system i- are
Unit: — listed. Lists are made by The Norwegian
Labour and Welfare Administration, refer
Website: — to the procurement of medical devices at
Nomenclature systems used for devices and tests: — national level section.
Website: https://www.helsedirektoratet.no/tema/beredskap-og-krisehandtering
e
The system has two levels; a national level
HTA unit/department includes the assessment of medical devices: Yes where decisions based on HTAs are made
Unit/department: Norwegian Knowledge Centre for the Health Services within by the four regional health authorities in
concert, and a local/”hospital-level” where
Norwegian Institute of Public Health (NIH). decisions are made based on the mini-
Website(s): https://www.fhi.no/en/qk/HTA/ HTAs performed locally in each hospital.
Pharmaceutics have to pass always by the
https://helsedirektoratet.no/english national level. The Norwegian Knowledge
Contact: — Email: Folkehelseinstituttet@fhi.no Centre for the Health Services (member of
the NIPH since 2016) do HTAs on selected

Name of regulatory agency: Norwegian Directorate of Health, Department of The Directorate of Health, Department of
Medical Devices and Medicinal Products. medical devices and medicinal products
is the Competent Authority for medical
Website(s): http://www.helsedir.no devices in Norway, it has the tasks of the
https://lovdata.no/dokument/SF/forskrift/2005-12-15-1690/*#&#x2a competent authority as they are given
in the European directives for medical
Contact: Ms. Marit Endresen Email: meddev-no@helsedir.no devices. These tasks, however, are not
Name(s) of other regulatory agency eg. for radiation equipment etc.: Directorate of identical with those listed under the
corresponding ones of this survey.
Health: Department of M;edical Devices and Medicinal Products.
Other agency’s website: https://lovdata.no/dokument/SF/forskrift/2005-12-15-
1690/*#&#x2a
258
WHO European Region
Norway
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: The use of GMDN is not imposed by law.
For regulatory purposes
Website: —

Procurement
National level procurement: Yes Website: https://www.helfo.no/produkt-og-prislister/
produkt-og-prislister?malgruppe=leverandor
Only procurement of devices being
Donations reimbursed via the blue prescription
system is carried out at a national level,
Policy or guideline: No Website: — by The Norwegian Labour and Welfare
Technical specifications Administration.
Website: —
Density per
population

Unit/Department: Norwegian Knowledge center for the Health Care Services, Department for Evidence-based Health
Care. Unit website: —
Contact name: Ms. Gro Jamtvedt and Ms. Inger Norderhaug Contact email: grj@nock.no
Website: —

Contacts
Name: — Name: —
Name: Ms. Gro Jamtvedt and Ms. Inger Norderhaug Name: —
Email: grj@nock.no Email: —
General comments (...Annex 1): Concerning the HT national policy, it was provided the following document: plan
van aanpak patientveiligheid medische technologie.pdf. Concerning the infrastructure section: As of 01.01.2009: 11 885
beds in specialised healthcare. 117 of these are in the private sector.
Oman

11.01 69
High
aged 30-70 yrs from 21.50% >10% (>25%) of — (—)
income (%):i
Human Development
Years

26.5 (84)
rank:f
High-technology
ICT Development
6.4 (62) exports (% of 1.30%
Index (rank):g

Website: —
Language(s): —

Unit: Directorate of Medical Technologies.
Website: —
Lists available: Yes Medical devices for specific procedures,
whenever required, are prepared or
Website: — modified based on the requirement from
end users. Available at Directorate of
Medical Technologies.
e
Drug control, bulk procurement and
HTA unit/department includes the assessment of medical devices: No distribution of drugs are managed by MoH.
Unit/department: — There are identified HTA activities but
there is no national unit per se.
Website(s): https://www.moh.gov.om/en/

Name of regulatory agency: Directorate General of Medical Supply, Ministry of —
Health.
Website(s): https://www.moh.gov.om/web/directorate-general-of-medical-supplies
Contact: Engr. Rashid bin Hamdan Al Hajri, DMT. Email: ralhajri@omantel.net.om
260
Oman
Use: Not specified
Website: —

Procurement
Donations The procurement guidelines are available
Policy or guideline: Yes Website: — at the Directorate of Medical Technologies.
Website: —
Density per
population

Unit/Department: Directorate of Medical Technologies. Unit website: —
Contact name: Engr. Rashid bin Hamdan Al Hajri Contact email: ralhajri@omantel.net.om
Type of inventories available: National inventory for medical equipment Available at the Directorate of Medical
Technologies.
Website: —
Use of management software: Yes Software name: Al Shifa.

Contacts
Name: Mr. Rashid Bin Hamdan Al Hajri Name: Mr. Jean Yaacoub Jabbour
Email: ralhajri@omantel.net.om Email: jabbourj@who.int
Name: — Name: Mrs. Reem Bou-Kamel
Email: — Email: boukamelr@oma.emro.who.int
Pakistan

65.18 45
Lower-Middle
4.5%
aged 30-70 yrs from 29.40% >10% (>25%) of
(0.5%)
income (%):i
Human Development
0.56
Years

(0.38): 22.3 (107)
medium
rank:f
High-technology
ICT Development
2.4 (148) exports (% of 2.30%
Index (rank):g

Website: https://www.dra.gov.pk

Unit: —
Website: —
The provinces develop their lists of
National list for specific clinical interventions/emergencies: equipment based on their health facilities,
Lists available: No the available funds, and according
to the Priced Vocabulary of Medical
Website: www.ppra.org.pk Stores (PVMS) (Available). World Health
https://www.dra.gov.pk Organization Pakistan share such lists
with the Ministry of Health at time of
emergency.
e
—
Website(s): —

Name of regulatory agency: Medical Devices and Medicated Cosmetics Division The WHO country team helped the
within the Drug Regulatory Authority. Ministry of Health in drafting rules for
regulations of medical devices, but
Website(s): https://www.dra.gov.pk/about-us/organization/divisions/ they are not applicable after the 18th
Contact: — Email: — amendment.
Name(s) of other regulatory agency eg. for radiation equipment etc.: Pakistan
Nuclear Regulatory Authority (PNRA does a partially regulation for some medical devices) other wise, there is no
authority.
Other agency’s website: http://www.pnra.org/
262
Pakistan
Website: https://www.dra.gov.pk

Procurement
Policy or guideline: Yes Website: https://www.dra.gov.pk/Home/MDMC#gsc.tab=0
Donations The procurement service rules 2003 (KPK)
Policy or guideline: No Website: https://www.dra.gov.pk issued by the finance department. The
procurement is carried out at a provincial
Technical specifications level and identified by SPRA etc. There is a
Technical specifications to support procurement or donations: Yes National inventory for medical equipment.

Website: http://www.sindhhealth.gov.pk/pprasindh.gov.pk
Density per
population

Type of inventories available: — A national inventory was previously
maintained but now is at a province/region
Website: — level, it is in pipeline.

Contacts
Name: Mr. Ayaz Ali khan Name: Dr. Palitha Gunarathna Mahipala
Email: ayazalikhan1@gmail.com Email: mahipalap@who.int
Name: — Name: —
General comments (...Annex 1): After the 18th amendment and devolution of the MoH, no person nor authority
can provide information, the WHO as convening body of health systems in Pakistan collected the information separately
from all regions/provinces then the information was compiled by the WHO focal person of health technologies.
Palau

16.85 59
Upper-Middle
aged 30-70 yrs from — >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
— (—) exports (% of 51.70%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): —
264
Palau
Website: —

Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: — Name: —
Panama

14.34 77
High
aged 30-70 yrs from 10.70% >10% (>25%) of — (—)
income (%):i
Human Development
0.82
Years

(0.64): 29 (73)
very high
rank:f
High-technology
ICT Development
4.9 (94) exports (% of 13.70%
Index (rank):g

Website: http://www.minsa.gob.pa/normatividad/leyes
Ministry of health responsible for health technology policy implementation: Comisión Nacional de Registro Nacional de
Oferentes - Departamento de investigación - Desarrollo Tecnológico en Salud y Comité Técnico Nacional Interinstitucional
- Dirección Nacional de Farmacias y Drogras - Laboratorio Central de Referencia.

Lists available: Yes Available at the specified website.
Unit: Comité Técnico Nacional Interinstitucional.
Website: http://appwebs.minsa.gob.pa/woferentes/ConsultaCatalogos.aspx
Website - hospitals: http://minsa.b-cdn.net/sites/default/files/transparencia/politicas_de_
salud_del_minsa.pdf
Website - laboratories: http://www.minsa.gob.pa/contenido/direccion-nacional-de-
farmacia-y-drogas
Website: —
e
HTA activities are performed in the
HTA unit/department includes the assessment of medical devices: No MoH, Caja de Seguro Social (CSS),
Unit/department: — and institutions such as the Instituto
Conmemorativo Gorgas de Estudios
Website(s): http://www.css.gob.pa/web/24-abril-2017ts.html de la Salud (1928) (GORGAS). HTA is
https://www.gacetaoficial.gob.pa/pdfTemp/25915/7314.pdf performed in several areas: pharmaceutics,
http://www.gorgas.gob.pa/departamento-de-tecnologia-sanitaria/ interventions, cost-effectiveness, etc.
In the ministry of health, they perform
Contact: Rusbel Batista Email: rusbelbatistaortega@gmail.com

Name of regulatory agency: Dirección Nacional de Dispositivos Médicos del —
Ministerio de Salud de Panamá
Website(s): http://www.minsa.gob.pa/direccion/direccion-nacional-de-dispositivos-medicos
Contact: Rusbel Batista Ortega Email: rvbatista@minsa.gob.pa
Other agency’s website: https://www.iaea.org/es/el-oiea/lista-de-estados-miembros
266
Panama
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed El sistema UMDNS ha sido adoptado en la
Use: Not specified legislación. Su implementación está aún en
proceso.
Website: http://www.minsa.gob.pa/
http://minsa.b-cdn.net/sites/default/files/normatividad/decreto_468_de_2007_para_
publicar_en_gaceta_2.pdf

Procurement
Policy or guideline: Yes Website: http://minsa.b-cdn.net/sites/default/files/normatividad/
ley_92_de_2019_0.pdf Medical device incorporation
http://minsa.b-cdn.net/sites/default/files/normatividad/decreto_ejecutivo_490_de_2020.pdf comments (...Annex 1):
La Caja de Seguro Social hace sus
National level procurement: Yes Website: http://minsa.b-cdn.net/sites/default/files/ procesos de adquisición de forma
normatividad/decreto_ejecutivo_490_de_2020.pdf independiente del Ministerio de Salud
http://appwebs.minsa.gob.pa/procedimientos/Procedimientos.aspx; pero sujeto al sistema de Fichas Técnicas
Nacionales en cuyas confecciones también
Donations participa.
Website: —
Density per
population

Unit/Department: Comisión Nacional de Oferentes. Unit website: http://minsa.b-cdn.net/sites/default/files/direcciones/informe_
dndm_14_agosto_2020.pdf
Contact name: Dr. Alejandro Martinez Contact email: amartinez@minsa.gob.pa
Website with publically available technical specifications: http://appwebs.minsa.gob.pa/woferentes/ConsultaCatalogos.aspx
Website: http://appwebs.minsa.gob.pa/woferentes/ConsultaCatalogos.aspx
Use of management software: Yes Software name: ECRI.

Contacts
Name: Lic. Sousa Name: Dra. Ana Rivière Cinnamond
Email: lsousa@minsa.gob.pa Email: rivierea@paho.org
Name: Dr. Alejandro Martinez Name: Dra. Didia Sagastume
Email: amartinez@minsa.gob.pa Email: sagastumed@paho.org

Papua New Guinea

43.93 33
Lower-Middle
aged 30-70 yrs from 36.00% >10% (>25%) of — (—)
income (%):i
Human Development
0.56
Years

(0.39): — (—)
medium
rank:f
High-technology
ICT Development
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
The 2011 initiative undertaken to establish
HTA unit/department includes the assessment of medical devices: No a national e-health strategic framework
Unit/department: — and committee, as first steps. There are
identified HTA activities but not national
Website(s): — unit. The Universal Health Care country
Contact: — Email: — goal is in progress.

Website(s): —
Contact: Ms. Jonila Kepas. Email: jjonilak248@gmail.com
268
Papua New Guinea

Website: —

Procurement
Donations —
Website: —
Density per
population

Type of inventories available: National Inventory for medical equipment —
Website: —

Contacts
Name: — Name: Ms. Anna Alexandra S. Maalsen
Email: — Email: maalsena@who.int
Name: — Name: —
Paraguay

18.9 61
Upper-Middle
aged 30-70 yrs from 16.00% >10% (>25%) of 7.1% (1.9%)
income (%):i
Human Development
0.73
Years

(0.56): 24.1 (97)
high
rank:f
High-technology
ICT Development
4.2 (113) exports (% of 7.20%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
HTA activities identified, but not proven at
HTA unit/department includes the assessment of medical devices: No national or subnational level.
Website(s): —
Contact: Mr. Adolfo Maldonado Email: ninomaldonado@hotmail.com

Name of regulatory agency: Dirección Nacional de Vigilancia Sanitaria (DINAVISA) —
Website(s): https://www.mspbs.gov.py/dnvs
Name(s) of other regulatory agency eg. for radiation equipment etc.: Autoridad
Reguladora Radiológica y Nuclear.
Other agency’s website: http://www.arrn.gov.py/
270
Paraguay
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified Se está elaborando un plan para proceder
con la instalación de un sistema de
Website: — nomenclatura.

Procurement
Donations Procurement guidelines: se inició la
Policy or guideline: No Website: — elaboración de directrices.
Website: —
Density per
population

Unit/Department: Dirección de Desarrollo de Servicios de Salud. Unit website: —
Contact name: Ms. Ana Bordon Contact email: acbo@hotmail.com
Website: —

Contacts
Name: Dr. Julio Borba Name: Dr. Marcelo Korc
Email: julioborba29@hotmail.com Email: korcmarc@paho.org
Name: Mirta Morán Name: Dra. Alejandra Carrillo
Email: nanita.moran@gmail.com Email: carrilloa@paho.org
General comments (...Annex 1): Concerning the HT national policy, it was provided the following document:
DECRETO EJECUTIVO 468.pdf
Peru

12.82 78
Upper-Middle
9.2%
aged 30-70 yrs from 9.70% >10% (>25%) of
(1.3%)
income (%):i
Human Development
0.78
Years

(0.63): 28.8 (76)
high
rank:f
High-technology
ICT Development
4.9 (96) exports (% of 4.10%
Index (rank):g

Website: http://www.digemid.minsa.gob.pe/Main.asp?Seccion=474
Ministry of health responsible for health technology policy implementation: National Authority for Pharmaceutical
Products, Medical Devices ans Sanitary Products (DIGEMID) from the Ministry of Health.

Unit: Dirección General de Medicamentos, Insumos y Drogas (DIGEMID)
Website: https://cdn.www.gob.pe/uploads/document/file/343934/Resoluci%C3%B3n_
Ministerial_N__670-2019-MINSA.PDF
Website - hospitals: http://www.minsa.gob.pa/direccion/direccion-de-infraestructura-de-
salud
http://ftp2.minsa.gob.pe/normaslegales/2011/RM369-2011-MINSA.PDF
Website - laboratories: http://www.digemid.minsa.gob.pe/main.asp?Seccion=933
There are National Standards or list
National list for specific clinical interventions/emergencies: of recommended medical devices for
Lists available: Yes specific procedures but it is managed by
protocolos of care at the Hospital, Health
Website: — Center or Specialty Hospital. For a), b) and
c) there are protocolos of care at level of
e
Three institutions perform HTA: Ministry
HTA unit/department includes the assessment of medical devices: Yes of Health-DIGEMID; National Institute of
Unit/department: National Network for Health Technology Assessment (RENETSA) Health (INS) and the Institute of Health
Technology Assessment and Research
Website(s): https://web.ins.gob.pe/ (IETSI-ESSALUD).
http://www.essalud.gob.pe/ietsi/ Besides this 3 institutions, there is one
more: INEN-Instituto Nacional de
Contact: INS Nora Reyes Puma Email: nreyes@ins.gob.pe Enfermedades Neoplásicas, that perform

Name of regulatory agency: Dirección General de Medicamentos, Insumos y Drogas —
(DIGEMED).
Website(s): http://www.digemid.minsa.gob.pe/Main.asp?Seccion=453
Contact: Ms. Silvia Perez Valdez Email: sperez@digemid.minsa.gob.pe
272
Peru
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed Ley Nº29459-D.S and the D.S. Nº 016-2011-
Use: Not specified SA.
Website: http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Publicaciones/
DocumentosConsulta/P08_234-2017-05-04.PDF
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Normatividad/2020/DS_036-
2020-SA.pdf

Procurement
Policy or guideline: Yes Website: http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/
PDF/Ley29459.pdf Medical device incorporation
National level procurement: Yes Website: https://www.gob.pe/minsa
—
Donations
Policy or guideline: Yes Website: http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/
PDF/Ley29459.pdf
Website: —
Density per
population

Unit/Department: Unit of Medical Devices. Unit website: —
Type of inventories available: None There are any kind of inventories for
medical devices available in the country.
Website: —

Contacts
Name: — Name: Dr. Carlos Garzon Becerra
Email: — Email: garzonc@paho.org
Name: — Name: Dr. Miguel Davila
Email: — Email: davilam@paho.org
Philippines

26.37 55
Lower-Middle
6.3%
aged 30-70 yrs from 24.50% >10% (>25%) of
(1.4%)
income (%):i
Human Development
0.72
Years

(0.59): 35.2 (50)
high
rank:f
High-technology
ICT Development
4.7 (101) exports (% of 62.20%
Index (rank):g

Website: —
Language(s): —

Lists available: Yes The lists are limited to diagnostics, no
interventional equipment noted (ie, ECMO,
Unit: Bureau of Health Devices and Technology(BHDT)- Department of Health (to DaVinci, etc.)
be renamed as Center for Device Regulation, Radiation Health and Research-Food
and Drug Authority).
Website: https://www.fda.gov.ph/
Website - hospitals: www.doh.gov.ph\licensing\bhfs
https://hfsrb.doh.gov.ph/
Website - laboratories: https://www.fda.gov.ph/
Lists available: Yes This is part of the requirements for the
licensing of health facilities. The given
Website: www.doh.gov.ph/asc_inspectiontool_partIII.general.pdf URL is for general surgery. The indicated
https://gppb.gov.ph/assets/pdfs/NPM%203-2020_Negotiated%20Procurement%20 website can be browsed for other
(Emergency%20Cases).pdf recommended medical devices for other
procedures.
e
HTAC has one biomedical engineer and
HTA unit/department includes the assessment of medical devices: Yes one medical physicist.
Unit/department: HTA Department of Health.
Website(s): https://hta.doh.gov.ph/
Contact: Dr. Anna Melissa S. Guerrero Email: asguerrero@doh.gov.ph; hta@doh.gov.ph

Name of regulatory agency: Bureau of Health Devices and Technology- Department —
of Health (to be renamed as Center for Device Regulation, Radiation Health and
Research-Food and Drug Authority).
Website(s): https://www.fda.gov.ph/
Contact: Dir. Maria Cecilia P. Matienzo Email: cdrrhr@fda.gov.ph; cdrrhr.lrd@fda.gov.ph
Name(s) of other regulatory agency eg. for radiation equipment etc.: Food and Drug Administration; Philippine Nuclear
Research Institute.
Other agency’s website: https://www.fda.gov.ph/
274 https://www.pnri.dost.gov.ph/
Philippines
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified The Philippines will be using the
Nomenclature that will be decided by the
Website: — member states of the ASEAN who are
working on the harmonization of medical
device regulation in the region, where
Medical device incorporation medical device nomenclature is one of the
concerns.
Procurement
Policy or guideline: Yes Website: https://www.gppb.gov.ph/gppb-admin/monitoring/
app/APP20-DOH_CO.pdf Medical device incorporation
National level procurement: No Website: https://doh.gov.ph/node/1468
The procurement for a medical device
Donations is part of the National Procurements
system of the Philippine Government
Policy or guideline: Yes Website: https://doh.gov.ph/node/1468 (see website). Procurement of medical
Technical specifications devices can be done at a national level, at a
regional level and local government units.
Website: https://home.doh.gov.ph/auth
Density per
population

Unit/Department: — Unit website: http://www.doh.gov.ph/asc_inspectiontool_partIII.general.pdf
Website: —

Contacts
Name: — Name: Dr. Rabindra Romuald Abeyasinghe
Email: — Email: abeyasingher@who.int
Name: Ms. Gladys Cabrera Name: —
Poland

4.36 74
High
14.1%
aged 30-70 yrs from 17.00% >10% (>25%) of
(1.3%)
income (%):i
Human Development
0.88
Years

(0.81): 40 (38)
very high
rank:f
High-technology
ICT Development
6.9 (49) exports (% of 10.10%
Index (rank):g

Website: —
Language(s): —

Lists available: No The polish competent authority for medical
devices is the Office for Registration of
Unit: — Medicinal products, Medical devices and
Biocidal products, which keeps the register
Website: — of medical devices in a database; it is only
Nomenclature systems used for devices and tests: — used for market surveillance and vigilance
Lists available: — There are no lists, but basic (minimal)
requirements regarding the necessary
Website - hospitals: — medical devices that are a part of the
health benefit package regulations and
Website - laboratories: — are created concerning the type of facility
Nomenclature systems used for devices and tests: — (including specialisation) and with clear-
Lists available: No There are no lists, but basic (minimal)
requirements regarding the necessary
Website: — medical devices that are a part of the
health benefit package regulations and
are created concerning the type of facility
e
National health technology assessment unit (including specialisation) and with clear-
HTA unit/department includes the assessment of medical devices: Yes AOTMiT evaluates pharmaceutical and
Unit/department: The Agency for Health Technology Assessment and Tariff System non-pharmaceutical technologies including
medical devices assessment. The Agency
(AOTMiT). for Health Technology Assessment and
Website(s): https://www.aotm.gov.pl/ Tariff System evaluates pharmaceutical
and non-pharmaceutical technologies
https://www2.aotm.gov.pl/hta/ including medical devices assessment.
Contact: — Email: sekretariat@aotm.gov.pl

Name of regulatory agency: The Office for Registration of Medicinal Products, The Ministry of Health is the national
Medical Devices and Biocidal Products. regulatory authority in the area of
the health system and The Office for
Website(s): http://urpl.gov.pl/en registration of Medicinal Products, Medical
Contact: — Email: wm@urpl.gov.pl Devices and Biocidal Products is the
polish competent authority responsible for
Name(s) of other regulatory agency eg. for radiation equipment etc.: — cooperation with European Commission
in the medical device regulatory area.
Other agency’s website: — Another regulatory agency is the Market
Surveillance, Vigilance system, Clinical trial
registration and Inspection, Cooperation
with the European Commission and other
276
WHO European Region
Poland
Website: https://ec.europa.eu/health/sites/health/files/md_topics-interest/docs/md_emdn_ of MD representatives (of both the
eudamed_nomenclature_en.pdf national MoH and the national agencies)
Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: Ms. Anna Rychert Name: Dr. Paloma Cuchi
Email: a.rychert@aotm.gov.pl Email: cuchip@who.int
Name: Mr. Wojciech Marciszko Name: —
Portugal

3.3 84
High
18.4%
aged 30-70 yrs from 11.00% >10% (>25%) of
(3.3%)
income (%):i
Human Development
0.86
Years

(0.76): 43.5 (31)
very high
rank:f
High-technology
ICT Development
7.1 (44) exports (% of 6.90%
Index (rank):g

Website: https://www.infarmed.pt/web/infarmed-en/medical-devices; https://www.infarmed.pt/web/infarmed/entidades/dispositivos-
medicos; https://www.infarmed.pt/web/infarmed/legislacao/legislacao-farmaceutica-compilada/titulo-v-produtos-de-saude/capitulo-
ii-dispositivos-medicos
Language(s): Anglais et Portugais
Ministry of health responsible for health technology policy implementation: Administração Central do Sistema de Saúde
(ACSS, IP).

Unit: —
Website: —
Website - laboratories: www.infarmed.pt/documents/15786/1076625/decreto_lei_20306-
97.pdf
https://www.infarmed.pt/documents/15786/1076625/125_DL_189_2000_VP.pdf
Website: —
e
Functions of Infarmed: Research,
HTA unit/department includes the assessment of medical devices: Yes assessment, registration, monitoring and
Unit/department: National Authority of Medicines and Health Products supervision of health products. Clinical
research evaluation, assessment and
(INFARMED). registration of CE marked medical devices,
Website(s): http://www.infarmed.pt/; https://www.infarmed.pt/web/infarmed/entidades/ notification of health care products and
dispositivos-medicos/avaliacao-de-tecnologias-de-saude/comparticipacao-de-dispositivos- market supervision activities.
medicos
Contact: Helena Monteiro Email: dats@infarmed.pt; avalia.dispositivos@infarmed.pt

Name of regulatory agency: National Authority of Medicines and Health Products —
(INFARMED, I.P.).
Website(s): https://www.infarmed.pt/web/infarmed
https://www.infarmed.pt/web/infarmed/entidades/dispositivos-medicos
Contact: Dr. António Faria Vaz Email: daps@infarmed.pt
Name(s) of other regulatory agency eg. for radiation equipment etc.: National Authority of Medicines and Health Products
(INFARMED, I.P.).
278 Other agency’s website: —
WHO European Region
Por tugal
C3D4 Official nomenclature system for medical devices: Yes Type: Based on EMDN Use: The Directorate-General of Health/
For regulatory purposes Ministry of Health of this country pointed
out that the official nomenclature system
Website: https://www.infarmed.pt/web/infarmed/pesquisa-dispositivos for medical devices and IVDs for registry
purposes is based on the European
Medical Device Nomenclature (EMDN).
Procurement
National level procurement: Yes Website: http://www.acss.min-saude.pt/category/
providers/healthcare-contracting/
Go to the website and search for the
http://www.acss.min-saude.pt/category/providers/facilities-and-equipments/ “contratoseaquisicoes” documents.
https://www.infarmed.pt/documents/15786/1076625/portaria_1253-9720.pdf
Donations
Website: —
Density per
population

Unit/Department: — Unit website: https://extranet.infarmed.pt/SIDM-fo/
Website with publically available technical specifications: https://extranet.infarmed.pt/SIDM-fo/
Website: https://www.infarmed.pt/web/infarmed/pesquisa-dispositivos
https://www.infarmed.pt/web/infarmed/pesquisa-dispositivos#

Contacts
Name: Ms. Luisa Taveira Name: —
Email: ltaveira@acss.min-saude.pt Email: —
Name: — Name: —

Qatar

5.76 74
High
aged 30-70 yrs from 10.70% >10% (>25%) of — (—)
income (%):i
Human Development
Years

30.8 (70)
rank:f
High-technology
ICT Development
7.2 (39) exports (% of 0.00%
Index (rank):g

Website: https://www.hamad.qa/EN/Pages/default.aspx
Ministry of health responsible for health technology policy implementation: Bio-Medical Engineering Department.

Lists available: Yes, but it is only a recommendation There are functional inventory of medical
devices for procurement and/ or
Unit: Bio-Medical Engineering Department. reimbursement in HMC hospitals. HMC
disciplines occupies functional inventory
Website: — of medical devices for prompt delivery
Nomenclature systems used for devices and tests: — of patient care services. Emergency
Lists available: Yes HMC disciplines occupies functional
inventory of medical devices for prompt
Website: — delivery of patient care services. It exists
the emergency prepardness policy
reference (including lists) too.
e
There are identified HTA activities. HTA
HTA unit/department includes the assessment of medical devices: No consultancy is required for building
Unit/department: — high-level infrastructure and there is the
formation of an HTA workforce but there
Website(s): https://www.moph.gov.qa/english/Pages/default.aspx is not a national unit. Drugs pricing falls
Contact: — Email: — on External Reference Pricing stated in
the national objectives towards Universal
Committee includes a biomedical or clinical engineer: Yes Health Care (UHC) implementation goal.

Name of regulatory agency: Medical Licensing Department. If ever a private agency, hospital or clinic
Website(s): https://www.moph.gov.qa/english/derpartments/policyaffairs/ needs a specific product they should
approach the Medical Licensing which
facilitieslicensingandaccreditationdepartment/Pages/default.aspx in turn seeks technical evaluation (such
https://www.moci.gov.qa/en/ as specification, safety, compliance, etc.)
from the Bio-Medical Engineering to
Contact: Dr. Jamal Rashid S. Khanji Email: — import the product to the country. Bio-Eng
Name(s) of other regulatory agency eg. for radiation equipment etc.: — does verify FDA, CE and/ or equivalent
compliance on medical device/ equipment
Other agency’s website: — for safety, especially for Hamad Medical
Corporation (HMC) hospitals.
280
Qatar
C3D4 Official nomenclature system for medical devices: Yes Type: Based on UMDNS Use: This is used for planning of medical
Not specified equipment for new / upcoming projects.
Website: https://www.ecri.org/solutions/umdns/

Policy or guideline: Yes Website: — The specification compliance on safety
National level procurement: Yes Website: https://www.hamad.qa/EN/Pages/default. and clinical requisites is regularly updated.
The Hamad Medical Corporation (HMC)
aspx Materials Management and Tender
Donations committee take over the procurement
activities of Medical and Non-Medical
Policy or guideline: Yes Website: — Equipment/ items for HMC hospitals,
and the ministry upon request, as deem
Technical specifications necessary. Specification of equipment
Technical specifications to support procurement or donations: Yes formulated in cooperation with end-user
prepared by Bio-eng.
Website: —
Density per
population

Unit/Department: Biomedical Engineering Department. Unit website: https://www.hamad.qa/EN/Pages/default.aspx
Contact name: Mr. Rashid al Mansoori Contact email: ralmansoori@hmc.org.qa
Website with publically available technical specifications: https://www.hamad.qa/en/hospitals-and-services/hhqi/pages/default.
aspx
Type of inventories available: National functional inventory for medical equipment Maintained GE AssetPlus for the functional
inventory of Medical equipment for the
Website: — Hamad Medical Corporation (HMC),
Use of management software: Yes Software name: AssetPlus (by GE). hospitals and Public Health Care Centers.

Contacts
Name: — Name: Dr. Rayana Ahmad Bou Haka
Email: — Email: emqatdesk@who.int
Name: — Name: —
General comments (...Annex 1): List of accredited HMC hospitals: Hamad General Hospital, Women’s Hospital,
Rumailah Hospital, Al Amal Hospital, and Al Khor Hospital. Emergency Medical Services (EMS), Pediatric Emergency,
Trauma Centers, Orthopedic Center, Dental and School Health, Home Healthcare, Primary Health Centers, Skilled Nursing
Facility. Upcoming projects: Qatar Heart Center, New Children’s Hospital, Al-Wakra Hospital. Please visit the Hamad
Medical Corporation website (www.hamad.qa) and the Qatar Supreme Council of Health website (https://www.moph.gov.qa/)
Republic of Korea

3.03 87
High
21.8%
aged 30-70 yrs from 7.30% >10% (>25%) of
(3.9%)
income (%):i
Human Development
0.92
Years

(0.82): 56.1 (10)
very high
rank:f
High-technology
ICT Development
8.9 (2) exports (% of 32.40%
Index (rank):g

Website: https://law.go.kr/
Language(s): Korean
Ministry of health responsible for health technology policy implementation: Division of Pharmaceutical Policy.

Lists available: Yes The Health Insurance and Review
Assessment (HIRA) is responsible for
Unit: Health Insurance Review & Assessment Service (HIRA). listing treatment materials for public
insurance.
Website: —
Website - laboratories: https://www.mfds.go.kr/eng/brd/m_40/view.
do?seq=72625&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_
itm_seq=0&company_cd=&company_nm=&page=1
Website: —
e
HTA is performed in a variety of health
HTA unit/department includes the assessment of medical devices: Yes areas including medical technologies,
Unit/department: National Evidence-based healthcare Collaborating Agency devices, interventions, etc.
(NECA).
Website(s): https://www.neca.re.kr/eng/index.do

Name of regulatory agency: Korea Food & Drug Administration. —
Website(s): https://www.mohw.go.kr
http://www.kimes.kr/eng/search/company_old_view.asp?ref_idx=598&lan=kor
Contact: Lim, Jai-gui Email: —
Name(s) of other regulatory agency eg. for radiation equipment etc.: Korea Institute
of Nuclear Safety (KINS); Nuclear Safety and Security Commission.
Other agency’s website: https://www.kins.re.kr/en
https://www.nssc.go.kr/en/index.do
282
Republic of Korea
Use: Not specified
Website: https://www.mfds.go.kr/eng/wpge/m_39/denofile.do

Procurement
Policy or guideline: Yes Website: http://www.pps.go.kr
National level procurement: Yes Website: http://www.pps.go.kr
Donations National and public hospitals purcharse
Policy or guideline: Yes Website: https://www.kofih.org/projects/healthcare-resources- medical equipments according to the
general procurement procedures.
support/
Website: —
Density per
population


Unit/Department: — Unit website: https://www.mfds.go.kr/eng/wpge/m_55/de011038l001.do
https://emed.mfds.go.kr/#!CEAAB02F010
Website with publically available technical specifications: https://www.mfds.go.kr/eng/brd/m_40/view.
do?seq=71809&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_
nm=&page=1
https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=71809&data_tp=A&file_seq=2
Type of inventories available: — The inventories for medical devices are not
managed by the government.
Website: https://www.mfds.go.kr/eng/brd/m_40/view.
do?seq=71809&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_
itm_seq=0&company_cd=&company_nm=&page=1
https://www.mfds.go.kr/eng/brd/m_41/down.do?brd_id=eng0012&seq=70934&data_
tp=A&file_seq=1

Contacts
Name: Mr. Jae Lee Kwang Name: —
Email: surreal@korea.kr Email: —
Name: Mr. Lim Jae-Gui Name: —

Email: guitar92@korea.kr Email: —
General comments (...Annex 1): Concerning the Infrastructure section: Korea Health Center is down to 29 beds.
Republic of Moldova

14.47 67
Upper-Middle
18.7%
aged 30-70 yrs from 24.10% >10% (>25%) of
(3.6%)
income (%):i
Human Development
0.75
Years

(0.67): 33 (59)
high
rank:f
High-technology
ICT Development
6.5 (59) exports (% of 3.00%
Index (rank):g

Website: https://msmps.gov.md/en
https://amdm.gov.md/ro
Language(s): Rumanian and Russian
Ministry of health responsible for health technology policy implementation: Department of Medicines and Medical Devices.

Lists available: No A special group of Agency of Medicines
and Medical Devices organise the
Unit: — procurement of medical equipment from
the state budget.
Website: —
Website - hospitals: https://amdm.gov.md/ro
http://lex.justice.md/UserFiles/File/2018/mo68-76md/an.53.docx
Lists available: Yes Medical standards on diagnostic and
treatment for pathological conditions
Website: www.ms.gov.md/public/info/ghid in surgery, therapeutic profile for adults
http://capcs.md/anunturi-licitatii-2020/ and children, have been developed. Also,
https://amdm.gov.md/ro/ development of guidelines is based on
international recommendations for family
e
HTA unit/department includes the assessment of medical devices: No a national unit per se.
Website(s): —

Name of regulatory agency: Agency of Medicines and Medical Devices. The National Center of Public Health
Website(s): https://msmps.gov.md/en/minister/organizare/subdiviziunile-ministerului/ is ensuring the control of the rules of
utilization of X-Ray equipment in all
https://amdm.gov.md medical institutions of the country.
Contact: Mr. Aleksandr Coman Email: office@amed.md
Name(s) of other regulatory agency eg. for radiation equipment etc.: The National
Center of Public Health; National Agency for Regulation of Nuclear and Radiological Activities (Ministry of Ecology and
Natural Resources).
Other agency’s website: http://www.vertic.org/media/National%20Legislation/Moldova/MD_Statute_ANRANR_eng1.pdf
284
WHO European Region
Republic of Moldova
Website: https://amdm.gov.md/ro/med-oborudovanie

Procurement
Policy or guideline: Yes Website: https://msmps.gov.md/sites/default/files/legislatie/
dokument_12.pdf Medical device incorporation
http://capcs.md/ comments (...Annex 1):
Procurement guidelines: Government
National level procurement: Yes Website: http://capcs.md/ Decree No. 568 (10.09.09). Guidelines
Donations on technical specifications: Decree 190
from 25.06.2009 establishes standard
Policy or guideline: Yes Website: http://capcs.md/ specifications for biochemical and
immunology test.
Website: https://msmps.gov.md/
https://amdm.gov.md/ro/
Density per
population

Unit/Department: Department of Medical Devices of the Agency of Medicines and Medical Devices. Unit website: http://
lex.justice.md/md/375113/
http://www.simdm.amdm.gov.md/simdm/en_US/
https://amdm.gov.md/ro;
Contact name: Mr. Aleksandr Spynu Contact email: aspinu@gmail.com
Website with publically available technical specifications: https://amdm.gov.md/sites/default/files/attach/Catalog%20
-ordinul%20nr.%20Rg04-000299%20din30.11.2020.xls
Type of inventories available: None It is not developed. A project to support
management of medical equipment is
Website: http://nomenclator.amdm.gov.md/ being developed: openMedis.
https://amdm.gov.md/sites/default/files/attach/Catalog%20-ordinul%20nr.%20Rg04-
000299%20din30.11.2020.xls
Use of management software: Yes Software name: OpenMedis.

Contacts
Name: — Name: Dr. Miljana Grbic
Email: — Email: grbicm@who.int
Name: Mr. Aleksandr Spynu Name: —

Email: aspinu@gmail.com Email: —
General comments (...Annex 1): The strategy to develop Health System during the period 2005-2017 as well as
the Plan of Action contains specific goals on strengthening the bases of technical material for healthcare.
Romania

6.88 71
High
13.4%
aged 30-70 yrs from 21.00% >10% (>25%) of
(2.2%)
income (%):i
Human Development
0.83
Years

(0.73): 36 (46)
very high
rank:f
High-technology
ICT Development
6.5 (58) exports (% of 11.10%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
Several national entities are in charge of
HTA unit/department includes the assessment of medical devices: Yes performing HTA activities, each one focus
Unit/department: National Drugs Agency. in various areas (see corresponding links).
Website(s): http://ms.ro
http://www.insp.gov.ro
http://www.snspms.ro
https://www.anm.ro/en/medicamente-de-uz-uman/evaluare-tehnologii-medicale/
Contact: — Email: secretariat@anm.ro

Name of regulatory agency: National Agency for Medicines and Medical Devices. —
Website(s): https://www.anm.ro/dispozitive-medicale/anunturi-importante-dispozitive-
medicale/
http://www.ms.ro/organizare/directia-politica-medicamentului-si-a-dispozitivelor-medicale/
Contact: Ms. Ana Maria Tanase Email: atanase@ms.ro
Name(s) of other regulatory agency eg. for radiation equipment etc.: Agentia
Nationala a Medicamentului si a Dispozitivelor Medicale din Romania (ANM).
Other agency’s website: http://www.cncan.ro/
https://www.anm.ro
286
WHO European Region
Romania
Policy or guideline: Yes Website: https://www.anm.ro/informatii-de-interes-public/
programul-anual-al-achizitiilor-publice/ Medical device incorporation
National level procurement: Yes Website: https://www.anm.ro/informatii-de-interes-
The procurement of high technologies
public/bugetul-cu-sursa-de-finantare/ devices is carried out at anational level.
https://www.anm.ro/dispozitive-medicale/formulare-si-tarife/ Go to the website and search for the
https://www.anm.ro/informatii-de-interes-public/contractele-de-achizitii-publice/ corresponding documents.
Donations
Website: https://www.anm.ro/dispozitive-medicale/eliberare-aviz-de-donatie/
Density per
population

Unit/Department: Ministy of Health. Unit website: https://www.anm.ro/dispozitive-medicale/vigilenta/
Website with publically available technical specifications: https://www.anm.ro/dispozitive-medicale/supraveghere-piata/
Website: https://www.anm.ro/dispozitive-medicale/inregistrare-dispozitive-medicale-in-
baza-nationala-de-date/

Contacts
Name: — Name: Dr. Andreea-Cassandra Butu
Email: — Email: butua@who.int
Name: Ms. Ioana Pertache Name: —
Email: pertache@ccss.ro Email: —

Russian Federation
Country indicators
5.8 75
Upper-Middle
4.9%
aged 30-70 yrs of 25.40% >10% (>25%) of
(0.6%)
NCDs (%):e corresponding
income (%):i
Human Development
0.82
(0.74): 35.6 (47)
very high
rank:f
High-technology
ICT Development
7.1 (45) exports (% of 13.00%
Index (rank):g

Website: https://roszdravnadzor.gov.ru/medproducts/documents/b40; https://minzdrav.gov.ru/documents; http://pravo.gov.ru/
MOH responsible for health technology policy implementation: —
Approved devices lists comments
National lists of medical devices (...Annex 1):
National list of approved priority/essential medical devices, —
(including IVDs), for procurement or reimbursement:
Lists available: Yes, but it is only a recommendation
Unit: Department of Health Care and Health Development.
Website: —
Health care facilities lists comments
Nomenclature systems used for devices and tests: — (...Annex 1):
National list for different types of healthcare facilities —
Website - hospitals: https://minzdrav.gov.ru/; http://www.medkirov.ru/licence/site/
LSPA342E9
Website - IVD: https://roszdravnadzor.gov.ru/medproducts
Nomenclature systems used for devices and tests: — —
National list for specific clinical interventions/emergencies:
Website(s): https://roszdravnadzor.gov.ru/medproducts/clinical; https://roszdravnadzor.
gov.ru/medproducts/monitoring; https://minzdrav.gov.B4%D0%scope=pages&title_on-
ly=false; https://minzdrav.gov.ru/documents/8005-prikaz-ministerstva-zdravoohraneni-
ya-100-ot-26-marta-1999-g (ambulatory specifications); https://minzdrav.gov.ru/docu-
ments/7418-svedeniya-o-vypolnenii-setevogo-grafika-realizatsii-prioritetnogo-natsionalnogo-
proekta-zdorovie-na-1-dekabrya-2010-goda; https://minzdrav.gov.ru/search_only=false;
https://minzdrav.gov.ru/search?order=relevapages&title_only=false
e
National health technology assessment unit HTA unit comments (...Annex 1):
Designated unit/department for health technology assessment (HTA):δ Yes
The HTA system development is inserted
National unit/department that includes HTA for medical devices: Yes, Department in the Russian Federation healthcare
of the Pharmaceutical and Medical Devices Market Development. legislation. Currently, the procedure for a
comprehensive assessment of drugs has
Website(s): https://minzdrav.gov.ru/documents been approved and is constantly being
Contact: — Email: — improved. However it is still at their start
phase for medical devices and biomedical
Committee includes a biomedical or clinical engineer: — products.

Name of regulatory agency: Federal Service on Surveillance (Roszdravnadzor), —
Federal Agency for Technical Regulation and Metrology (Gosstandart), Federal
Service for Supervision in the Area of Consumer Rights and Welfare Protection
(Rospotrebnadoz).
Website(s): http://roszdravnadzor.ru/
Contact: — Email: interdep@rosminzdrav.ru
Name(s) of other regulatory agency eg. for radiation equipment etc.: Federal Environmental, Industrial and Nuclear
Supervision Service of Russia; Ministry of Health of the Russian Federation.
288 Other agency’s website: http://en.gosnadzor.gov.ru/; https://portal.egisz.rosminzdrav.ru/
WHO European Region
Russian Federation
Use: Not specified
Website: https://roszdravnadzor.gov.ru/services/mi_reesetr

Procurement
Policy or guideline: Yes Website: https://minzdrav.gov.ru/ministry/tenders/plan-- Medical device incorporation
ot-27-06-2016; https://minzdrav.gov.ru/ministry/tenders comments (...Annex 1):
National level procurement: No Website: https://minzdrav.gov.ru/ministry/tenders —
Donations
Policy or guideline: Yes Website: https://minzdrav.gov.ru/documents/8014-
federalnyy-zakon-1499-1-ot-28-iyunya-1991-g; https://minzdrav.gov.ru/ministry/tenders/
pgz-2020
Website: https://minzdrav.gov.ru; https://roszdravnadzor.gov.ru/en/medproducts/control; http://www.rosminzdrav.ru/
documents/8185-federalnyy-zakon-ot-5-aprelya-2013-g-44-fz-o-kontraktnoy-sisteme-v-sfere-zakupok-tovarov-rabot-uslug-
dlya-obespecheniya-gosudarstvennyh-i-munitsipalnyh-nuzhd
Density per Density per

Medical equipment Total 1,000,000 Healthcare facilityγ Total 100,000
population population
Magnetic Resonance Imaging:α 711 4.87 Health posts: n/a n/a
Computerized Tomography
1963 13.45 Health centres: n/a n/a
Scanner:α
Positron Emission Tomography
n/a n/a General/district hospitals: n/a n/a
Scanner:α
Gamma camera or nuclear Specialized/regional/national
n/a n/a n/a n/a
medicine:α hospitals:
Estimation % of health facilities with none
n/a
or very limited oxygen supply:

Unit/Department: Department of Health Care and Health Development. Unit website: https://roszdravnadzor.gov.ru/
Contact name: Ms. Olga Krivonos Vladimirovna Contact email: KrivonosOV@rosminzdrav.ru
Website: https://roszdravnadzor.gov.ru/services/misearch;

Density of medical doctors (per 10 000 population):ε 44.4
Contacts
MOH focal point WHO health products focal point:
Name: — Name: —
Department: — Email: —
Email: — WHO Representative/WHO Liason Officer:
Other country focal point Name: Dr. Melita Vujnovic
Name: Ms. Olga Krivonos Vladimirovna Email: vujnovicm@who.int
Email: KrivonosOV@rosminzdrav.ru
a UN POP WPP 2019 (2020 POP) f UN POP 2019 δ Latest (2015-21): WHO HTA/HBP 2021 β Latest (2013-21): WHO GHO/2021
b WB FY21 2019 g ITU 2017 survey or WHO HTA 2015 survey or survey or IAEA (2017-21)
c UN POP WPP 2019 (1990-20 MOR) h WHO GHO 2017 WHO 2021 survey γ Latest (2014-21): WHO
d WHO GHO 2019 i WHO GHO 2010-18 α Latest (2013-21): WHO GHO/2021 GHO/2021 survey
e WHO GHO 2016 j WIPO 2020 survey or OECD (2017-19) ε WHO GHO 2010-18
289
k UN and WB 2017-19 n/a not applicable/not available
Rwanda

40.47 54
Low
1.2%
aged 30-70 yrs from 20.20% >10% (>25%) of
(0.1%)
income (%):i
Human Development
0.54
Years

(0.39): 25.1 (91)
low
rank:f
High-technology
ICT Development
2.2 (153) exports (% of 10.60%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
There are identified HTA activities which
HTA unit/department includes the assessment of medical devices: No are specifically done in pharmaceutics
Unit/department: — for pricing and reimbursements as well
as health economics; however, there is no
Website(s): — national unit.

Name of regulatory agency: Rwanda Food and Drugs Authority (Rwanda FDA) —
Website(s): https://www.rwandafda.gov.rw/home
290
WHO African Region
Rwanda
C3D4 Official nomenclature system for medical devices: Yes Type: More than one system Rwanda has started to use Online Public
Use: For various purposes Procurement, each device should have an
unique identification code (mainly based
Website: — on UMDNS). But it is challenging when
dealing with different code nomenclature
such as the sterilizer, autoclave or medical
Medical device incorporation gases. Rwanda uses UMDNS for inventory
and maintenance of medical equipment.
Procurement
Donations —
Website: —
Density per
population

Website: —

Contacts
Name: — Name: Dr. Brian Clever Chirombo
Email: — Email: chirombob@who.int
Name: — Name: —
Saint Kitts and Nevis

14.99 72
High
aged 30-70 yrs from — >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
7.2 (37) exports (% of 34.60%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): —
292
Saint Kitts and Nevis

Website: —

Procurement
Donations Hospital management purchases devices
Policy or guideline: No Website: — directly from vendors.
Website: —
Density per
population
Radiotherapy:β 0 0

Website: —

Contacts
Name: Mr. Patrick Martin Name: Dra. Amalia Del Riego
Email: skncmo@yahoo.com Email: delriegoa@paho.org
Name: — Name: Dr. Cecilia Acuñ
Saint Lucia

24.4 72
Upper-Middle
aged 30-70 yrs from 17.70% >10% (>25%) of — (—)
income (%):i
Human Development
0.76
Years

(0.63): — (—)
high
rank:f
High-technology
ICT Development
4.6 (104) exports (% of 10.50%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Name of regulatory agency: — There is the Bureau of Standards which will
Website(s): — do the regulatory activities.
294
Saint Lucia
Website: —

Procurement
Donations The procurement at a national level
Policy or guideline: No Website: — is not for medical equipment, but for
pharmaceuticals.
Website: —
Density per
population
Radiotherapy:β 0 0

Type of inventories available: None The medical equipment inventories of
public hospitals exist. The functional status
Website: — of such equipment is reflected in these
Use of management software: No Software name: — lists. No PET scanners are available on the
island. CT and MRI are available only in one
private hospital facility.
Contacts
Name: Mr. Protus Angus Jean Baptiste Name: Dra. Amalia Del Riego
Email: Mellow64@gmail.com Email: delriegoa@paho.org
Name: — Name: Dr. Cecilia Acuñ
Saint Vincent and the Grenadines

14.12 73
Upper-Middle
aged 30-70 yrs from 20.70% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
5.5 (82) exports (% of 9.90%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
HTA unit/department includes the assessment of medical devices: No a national unit. The development of one is
Unit/department: — in progress.
Website(s): http://health.gov.vc/health/index.php/health-information-system

Website(s): —
296
Saint Vincent and the Grenadines

Website: —

Procurement
Donations —
Website: —
Density per
population
Radiotherapy:β 0 0

Type of inventories available: None No national inventory exists.
Website: —

Contacts
Name: Mr. Fitzroy T. Jones Name: Dra. Amalia Del Riego
Email: mcmh@gov.vc Email: delriegoa@paho.org
Name: Mr. Pedro Richards Name: Dr. Cecilia Acuña
Email: pedradxray@yahoo.com Email: acunamar@paho.org
Samoa

17.01 53
Lower-Middle
aged 30-70 yrs from 31.20% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
3.3 (127) exports (% of 2.30%
Index (rank):g

Website: —
Language(s): —

Unit: Biomedical Engineering Unit.
Website: —
Lists available: Yes Please refer to Biomedical Engineering
Unit Head, Mr. Galuafi Vaoga at email:
Website: https://www.samoagovt.ws/tag/ministry-of-health/ biomed@nhs.gov.ws.
e
HTA unit/department includes the assessment of medical devices: No a national unit. MoH together with National
Unit/department: — Health Services (NHS) intend to develop
one, but it is still on progress.
Website(s): —

Name of regulatory agency: Ministry of Health, Medical Equipment Management —
Committee.
Website(s): https://www.samoagovt.ws/tag/ministry-of-health/
Contact: Ms. Palanitina Toelupe Email: —
Health Services Motootua Samoa, Government Apia Samoa.
Other agency’s website: https://www.health.gov.ws/
298
Samoa
Use: For procurement purposes
Website: —

Procurement
Policy or guideline: Yes Website: www.mof.gov.ws
Donations For more information refer to the Biomed
Policy or guideline: Yes Website: — Engineering Unit.
Website: —
Density per
population
Radiotherapy:β 0 0

Unit/Department: Tupua Tamasese Meaole (TTM) Hospital Administrator. Unit website: —
Contact name: Ms. Kristy. T. Contact email: KristyT@nhs.gov.ws
Website: —

Contacts
Name: Ms. Kristy. T. Name: —
Email: KristyT@nhs.gov.ws Email: —
General comments (...Annex 1): Concerning the Infrastructure section: there are 18 General Practicioner Clinics in
the Private sector.
San Marino

1.76 82
High
aged 30-70 yrs from — >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—): — (—)
rank:f
High-technology
ICT Development
Index (rank):g

Website: http://www.sanita.sm/on-line/home/authority-sanitaria.html
Language(s): Italiano
Ministry of health responsible for health technology policy implementation: Health Authority for Authorization,
Accreditation and Quality of Health Services.

Unit: —
Website: —
Website: —
e
Website(s): http://www.sanita.sm/on-line/home.html

Name of regulatory agency: Health Authority for Authorization, Accreditation and —
Quality of Health Services.
Website(s): http://www.sanita.sm/on-line/home/authority-sanitaria.html
Contact: Mr. Andrea Gualtieri. Email: andrea.gualtieri.authority@pa.sm
300
WHO European Region
San Marino
Website: —

Procurement
Donations —
Website: —
Density per
population
Radiotherapy:β 0 0

Unit/Department: Health Authority for Authorization, Accreditation and Quality of Health Services. Unit website: http://
www.sanita.sm/on-line/home/authority-sanitaria/vigilanza-e-gestione-del-rischio-clinico.html
Contact name: Mr. Andrea Gualtieri Contact email: andrea.gualtieri.authority@pa.sm
Website with publically available technical specifications: http://www.sanita.sm/on-line/home/authority-sanitaria/vigilanza-e-
gestione-del-rischio-clinico.html
Website: —

Contacts
Name: Mr. Andrea Gualtieri Name: —
Email: andrea.gualtieri.authority@pa.sm Email: —
Name: — Name: —
General comments (...Annex 1): For specialized care and diagnostics, patients can be treated in italian hospitals
that have agreements with San Marino.
Sao Tome and Principe

16.14 60
Lower-Middle
aged 30-70 yrs from 21.00% >10% (>25%) of — (—)
income (%):i
Human Development
0.63
Years

(0.52): — (—)
medium
rank:f
High-technology
ICT Development
3.1 (132) exports (% of 17.00%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Lists available: No Il n’existe pas au niveau national aucuen
liste recomandant des technologies de
Website: — sante.
e
—
Website(s): —

Website(s): —
302
WHO African Region

Website: —

Procurement
Donations —
Website: —
Density per
population


Type of inventories available: None L’inventaire des equipments medicaux
existant est caduque (2002) Apres
Website: — cette date un nombre considerable des
Use of management software: No Software name: — equipaments ont rentres en charge.

Contacts
Name: Mr. Florentino Fernandes Dos Ramos Name: Dr. Anne Marie F. J. Ancia
Email: frigao@hotmail.com Email: anciaa@who.int
Name: — Name: Dr. Claudina Augusto da Cruz
Email: — Email: cruzc@who.int
Saudi Arabia

7.01 73
High
aged 30-70 yrs from 20.90% >10% (>25%) of — (—)
income (%):i
Human Development
Years

30.9 (66)
rank:f
High-technology
ICT Development
6.7 (54) exports (% of 0.60%
Index (rank):g

Website: http://www.sfda.gov.sa
Ministry of health responsible for health technology policy implementation: General Supplies and Equipment Directorate.

Unit: National Unified Procurement Company for Medical Supplies (NUPCO) & Saudi
Food and Drug Administration (SFDA).
Website: —
Lists available: Yes Food and Drug Adminstration -
Specification and Measurement
Website: — Administration.
e
Designated unit/department for health technology assessment (HTA):δ Yes The Ministry of Health supports the
creation of a national entity for HTA
HTA unit/department includes the assessment of medical devices: Yes in healthcare as part of the National
Unit/department: Saudi Food and Drug Authority. Transformation Program. The new HTA
entity will deal mainly with pharmaceutics
Website(s): https://beta.sfda.gov.sa/sites/default/files/2020-03/MDS%E2%80%93G28.pdf but is intended to extends to other health
Contact: — Email: webmaster@sfda.gov.sa products such as devices. Informed HTA
decisions were rarely identified for medical
Committee includes a biomedical or clinical engineer: — devices.

Name of regulatory agency: Directorates of Supplies and Equipment and —
Maintenance.
Website(s): http://www.sfda.gov.sa/ar/Pages/default.aspx
Contact: Mr. Mohamed Bani Al-Hathri and Mr. Abdel-Rahman Al-Zamel Email:
Bani5442@hotmail.com
Name(s) of other regulatory agency eg. for radiation equipment etc.: Saudi Food & Drug Authority.
304
Saudi Arabia
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed A committee inside NUPCO has been
Use: For regulatory and procurement purposes established for that purpose and the work
is in progress.
Website: http://www.nupco.com

Procurement
Policy or guideline: Yes Website: http://www.nupco.com
National level procurement: Yes Website: http://www.nupco.com
Donations National Unified Procurement Company
Policy or guideline: Yes Website: — for Medical Supplies (NUPCO).
Website: —
Density per
population

Unit/Department: Maintenance Directorate. Unit website: —
Contact name: Mr. Abdel-Rahman Al-Zamel Contact email: Abomohanad@yahoo.com
Type of inventories available: National inventory for medical equipment For every hospital and health centre there
is a maintenance-specialized company
Website: — contracted to make the inventory and
Use of management software: Yes Software name: Bank Maintennace. perform necessary maintenance activities
for all medical devices within the facility.
Also, there is a National inventory for high
cost technologies (such as MRI, CT or PET
scanners).
Contacts
Name: Mr. Mohamed Bani Al-Harthi Name: Dr. Ibrahim Jawdat El-Ziq
Email: Bani5442@hotmail.com Email: elziqi@who.int
Name: Mr. Abdel-Rahman Al-Zamel Name: —
Email: Abomohanad@yahoo.com Email: —
General comments (...Annex 1): Concerning the HT national policy it is stated on the Medical Egypt Management
Plan (Corporate).
Senegal

38.08 49
Lower-Middle
3.3%
aged 30-70 yrs from 19.50% >10% (>25%) of
(0.2%)
income (%):i
Human Development
0.51
Years

(0.35): 23.7 (102)
low
rank:f
High-technology
ICT Development
2.7 (142) exports (% of 0.90%
Index (rank):g

Website: http://www.sante.gouv.sn
Ministry of health responsible for health technology policy implementation: Direction des Infrastrutures, des Equipements
et de la Maintenance.

Unit: Direction des Infrastrutures, des Equipements et de la Maintenance (DIEM).
Website: —
Il existe une liste standard de base pour
Lists available: Yes toutes les structures sanitaires. Pour la
Website: — plupart des acquisitions, les specifications
techniques des équipements sont réalisées
par la Direction des Equipements et de la
e
National health technology assessment unit Maintenance. Voir aussi les spécifications
—
Website(s): http://www.sante.gouv.sn
http://www.sante.gouv.sn/les-directions/la-direction-de-l%E2%80%99administration-
g%C3%A9n%C3%A9rale-et-de-l%E2%80%99equipement

Name of regulatory agency: La Direction des Infrastructures, des Equipements et de —
la Maintenance (DIEM).
Website(s): http://www.sante.gouv.sn
http://www.sante.gouv.sn/les-directions/la-direction-g%C3%A9n%C3%A9rale-de-la-
sant%C3%A9-publique
Contact: Monsieur Amad Diouf Email: amadediouf@yahoo.fr
Name(s) of other regulatory agency eg. for radiation equipment etc.: Autorité de Radioprotection et de Surêté Nucléaire.
Other agency’s website: http://www.sante.gouv.sn/les-services-rattaches/le-laboratoire-national-de-contr%C3%B4le-des-
m%C3%A9dicaments
306
WHO African Region
Senegal
Use: For procurement purposes
Website: —

Procurement
Policy or guideline: Yes Website: http://www.sante.gouv.sn
Donations On procéde à des appels d’offres
Policy or guideline: Yes Website: — nationaux et les representants des
fabricants etrangers fournissent les
Technical specifications équipements.
Website: —
Density per
population

Unit/Department: Department for Infrastructure, Equipment, and Maintenance (DIEM). Unit website: http://www.sante.gouv.
sn/
Contact name: Monsieur Amad Diouf Contact email: amadediouf@yahoo.fr
Website with publically available technical specifications: http://www.sante.gouv.sn/les-directions/la-direction-de-la-pharmacie-
et-du-m%C3%A9dicament
Type of inventories available: National inventory for medical equipment On a une inventaire national des
équipements médicaux (2009).
Website: —
Use of management software: Yes Software name: Système de gestion de la
maintenance assistée par ordinateur (GMAO).

Contacts
Name: Mr. Amad Diouf Name: Dr. Lucile Imboua-Niava
Email: amadediouf@yahoo.fr Email: imboual@who.int
Name: Mme. Awa Ndiaye Diouf Name: —
Email: awandiayediouf@yahoo.fr Email: —
Serbia

5.63 71
Upper-Middle
8.1%
aged 30-70 yrs from 22.00% >10% (>25%) of
(0.5%)
income (%):i
Human Development
Years

34.3 (53)
rank:f
High-technology
ICT Development
6.6 (55) exports (% of —
Index (rank):g

Website: http://www.zdravlje.gov.rs/index.php?
Language(s): Serbian and English
Ministry of health responsible for health technology policy implementation: Committee for Health Technology Assessment.

Lists available: Yes Not available at the moment.
Unit: Committee for Health Technology Assessment.
Website: —
Website - hospitals: http://www.zdravlje.gov.rs/
https://www.alims.gov.rs/eng/files/2018/11/Rulebook-on-Essential-Requirements-for-
medical-devices.docx
Website - laboratories: https://www.zdravlje.gov.rs/tekst/341790/odeljenje-inspekcije-za-
lekove-medicinska-sredstva-i-psihoaktivne-kontrolisane-supstance-i-prekursore.php
Lists available: No There are no specific national standards
nor recommended medical devices for
Website: — specific procedures. And there are no
lists recommending health techology for
different diseases/situations.
e
It conducts centralized public procurement
HTA unit/department includes the assessment of medical devices: Yes for health products including devices. HTA
Unit/department: Ministry of Health - Committee for health technology assessment. is in the law and with a centralized national
unit either MoH sector for inspection affairs
Website(s): https://www.zdravlje.gov.rs/tekst/350554/pravilnik-o-blizim-uslovima-i-nacinu- or Public Health Institute (NIS).
vrsenja-procene-zdravstvenih-tehnologija.php
https://www.zdravlje.gov.rs/tekst/333403/sektor-za-inspekcijske-poslove.php
http://www.izjz-nis.org.rs/en/indexEN.html

Name of regulatory agency: Medicines and Medical Devices Agency (ALIMS). —
Website(s): https://www.alims.gov.rs/eng/
Contact: Ms. Tatjana Sipetic Email: —
308
WHO European Region
Serbia
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed National nomenclature is in the process of
Use: Not specified updating and amendment.
Website: http://www.zdravlje.gov.rs

Procurement
National level procurement: Yes Website: https://www.zdravlje.gov.rs/
Donations Go to the website and search for the
Policy or guideline: No Website: — corresponding documents.
Website: —
Density per
population

Type of inventories available: National inventory for medical equipment The inventory was made, in 2000,
according to methodology. In 2003,
Website: — European Agency for Reconstruction
Use of management software: Yes Software name: — commissioned a project performed by
IPH Serbia, but the methodology was not
included in the national Law on Health
Records and Statistics and has not been
adopted, so the inventory continued to
Number of biomedical/clinical engineers professionals in the country:γ 300 be performed on annual basis based
on the existing Law on Health Records
and classification of medical equipment
Contacts
Name: — Name: Dr. Fabio Scano
Email: — Email: scanof@who.int
Name: — Name: —
General comments (...Annex 1): The Institute of Public Health of Serbia has a department for health technology
assessment mainly responsible for updating nomenclature and type of technology.
Seychelles

13.94 70
High
3.5%
aged 30-70 yrs from 21.10% >10% (>25%) of
(1.6%)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
5 (90) exports (% of 2.20%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): —
310
WHO African Region
Seychelles
Website: —

Procurement
Donations It is a small committee that meets to
Policy or guideline: No Website: — discuss equipment request by the various
units within the Ministry of Health. Please
Technical specifications note that Seychelles has a small population
Technical specifications to support procurement or donations: No and we do not purchase equipment on a
big scale.
Website: —
Density per
population


Website: —

Contacts
Name: — Name: Dr. Teniin Gakuruh
Email: — Email: gakuruht@who.int
Name: — Name: —
Sierra Leone

107.83 39
Low
54.2%
aged 30-70 yrs from 23.60% >10% (>25%) of
(22.2%)
income (%):i
Human Development
0.45
Years

(0.29): — (—)
low
rank:f
High-technology
ICT Development
— (—) exports (% of 0.70%
Index (rank):g

Website: —

Lists available: Yes Lists for procurements are still being
worked on not yet completed. However
Unit: Procurement Unit. we do have public health emergency
situations lists.
Website: —
Website: —
e
—
Website(s): —

Name of regulatory agency: Procurement Unit, Ministry of Health and Sanitation. —
Website(s): http://www.health.gov.sl/home/
http://www.pharmacyboard.gov.sl/
Contact: Mr. Mohamed Kallon Email: —
312
WHO African Region
Sierra Leone
C3D4 Official nomenclature system for medical devices: Yes Type: Based on UMDNS Use: The document is not available for the
For procurement purposes Facilities and Maintenance Unit.
Website: —

Procurement
Donations Most of the equipment has been used and
Policy or guideline: Yes Website: — found incomplete, and this is the reason
why its installation is difficult. Procurement
Technical specifications of medical devices is carried out without
Technical specifications to support procurement or donations: No involving the specialists.
Website: —
Density per
population


Unit/Department: Procurement Unit. Unit website: —
Contact name: Mr. Mohamed Kallon Contact email: —
Type of inventories available: National inventory for medical equipment The last inventory was done twelve years
ago. Looking forward to start another one.
Website: —

Contacts
Name: — Name: Dr. Evans Majani Liyosi
Email: — Email: liyosie@who.int
Name: Mr. Mohamed Kallon Name: —
General comments (...Annex 1): There is a limited number of technical personnel to meet the service demand.
Most of the equipment supplied by donors are obsolete and out of order.
Singapore

2.24 86
High
9.0%
aged 30-70 yrs from 9.50% >10% (>25%) of
(1.5%)
income (%):i
Human Development
0.94
Years

(0.81): 56.6 (8)
very high
rank:f
High-technology
ICT Development
8.1 (18) exports (% of 52.10%
Index (rank):g

Website: https://www.hsa.gov.sg/

Lists available: Yes A list is available in the form of the
Singapore Medical Device Register
Unit: Medical Devices Branch / Health Sciences Authority (HSA). (SMDR). This shows all approved medical
devices in Singapore and provides
Website: http://eservice.hsa.gov.sg/medics/md/mdEnquiry.do?action=getAllDevices information on them. It is not a list of
Nomenclature systems used for devices and tests: — recommended devices for procurement.
Website: —
e
—
Unit/department: Health Technology Assessment Branch, and Agency for care
effectiveness (ACE).
Website(s): https://www.ace-hta.gov.sg/

Name of regulatory agency: Medical Device Branch, Health Sciences Authority. —
Website(s): https://www.hsa.gov.sg/medical-devices/
Contact: Ms. Joanna Koh Email: joanna_koh@hsa.gov.sg
314
Singapore
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified The Global Medical Device Nomenclature
(GMDN) is used as an internal reference
Website: https://www.hsa.gov.sg/medical-devices/registration/guides and it is not required for medical device
product registration

Procurement
Donations —
Website: —
Density per
population

Unit/Department: Health Technology Assessment Branch, Ministry of Health. Unit website: https://www.hsa.gov.sg/medical-
devices
Contact name: Dr. Pwee Keng Ho Contact email: pwee_keng_ho@moh.gov.sg
Website with publically available technical specifications: https://www.hsa.gov.sg/medical-devices
Website: —

Contacts
Name: — Name: —
Email: — Email: wpmyswr@who.int
Name: Dr. Pwee Keng Ho Name: —
Email: pwee_keng_ho@moh.gov.sg Email: —
Slovakia

5.75 77
High
3.8%
aged 30-70 yrs from 15.50% >10% (>25%) of
(0.4%)
income (%):i
Human Development
0.86
Years

(0.81): 39.7 (39)
very high
rank:f
High-technology
ICT Development
7.1 (46) exports (% of 9.90%
Index (rank):g

Website: http://www.skmed.sk
Language(s): Slovak
Ministry of health responsible for health technology policy implementation: Department of Categorization Pricing and
Drug Policy.

Unit: Ministry of Health.
Website: https://www.health.gov.sk/?zoznam-kategorizovanych-zdravotnickych-pomocok
https://www.health.gov.sk/?zkszm
Lists available: No There is no list recomending health
technology for above mentioned diseases/
Website: — situations.
e
The Working Group for
HTA unit/department includes the assessment of medical devices: No Pharmacoeconomics, Clinical Outcomes
Unit/department: — and Health Technology Assessment of the
Slovak Ministry of Health perform HTA, but
Website(s): https://www.slov-lex.sk/pravne-predpisy/SK/ZZ/2011/362/20210526 not specifically for medical devices.
https://www.slov-lex.sk/pravne-predpisy/SK/ZZ/2011/363/20210413

Name of regulatory agency: State Institute for Drug Control. —
Website(s): https://www.sukl.sk/sk/zdravotnicke-pomocky-informacie?page_id=495
Contact: Ing. Ivan Bernát Email: pomocky@sukl.sk
Regulatory Authority of the Slovak Republic.
Other agency’s website: https://www.ujd.gov.sk/ujd/www1.nsf/viewByKeyMenu/En-01
316
WHO European Region
Slovakia
Website: http://www.health.gov.sk of MD representatives (of both the
Donations —
Website: —
Density per
population

Website: —

Contacts
Name: Dr. Branislav Jadud Name: Dr. Tatul Hakobyan
Email: branislav.jadud@health.gov.sk Email: hakobyant@who.int
Name: — Name: —
Slovenia

2.18 80
High
2.9%
aged 30-70 yrs from 11.50% >10% (>25%) of
(0.3%)
income (%):i
Human Development
0.92
Years

(0.88): 42.9 (32)
very high
rank:f
High-technology
ICT Development
7.4 (33) exports (% of 7.40%
Index (rank):g

Website: http:/ / pisrs.si/ Pis.web/ pregledPredpisa?id=RESO102#
Language(s): Slovenian
Ministry of health responsible for health technology policy implementation: Directorate for healthcare economics

Unit: Agency for Medicinal Products and Medical Devices of the Republic of
Slovenia
Website: https://www.jazmp.si/en/regulation-of-activities/lists/
Website - hospitals: https://www.zdrzz.si/O_Zdruzenju/
National list for specific clinical interventions/emergencies: There are many boards (Slovenian
Lists available: Yes Collegiate Boards) each responsible
Website: — for one area of medicine. Those bodies
produce recommendations on specific
procedures where deemed necessary.
e
National health technology assessment unit Currently, recommendations are under
HTA framework is not done yet, but HTA
HTA unit/department includes the assessment of medical devices: — processes are in an existing framework.
Unit/department: — HTA decision-taking is done by the
following institutions: MoH, National
Website(s): — Institute of Public Health, and the Agency
Contact: — Email: — for Medicinal Products and Medical
Devices of the Republic of Slovenia
Committee includes a biomedical or clinical engineer: — (JAZMP).

Name of regulatory agency: Javna Agencija za zdravila in medicinske pripomocke / —
Agency for Medicinal Products and Medical Devicesof the Republic of Slovenia.
Website(s): http://www.jazmp.si/en/medical_devices/
Contact: Momir Radulovi_ Email: info@jazmp.si
Name(s) of other regulatory agency eg. for radiation equipment etc.: Slovenian
Nuclear Safety Administration; Agency for Medicinal Products and and Medical Devices of the Republic of Slovenia.
Other agency’s website: https://www.gov.si/en/state-authorities/bodies-within-ministries/slovenian-nuclear-safety-administration/
318
WHO European Region
Slovenia
Website: https://www.enarocanje.si/ of MD representatives (of both the
https://simap.ted.europa.eu/cpv national MoH and the national agencies)
https://webgate.ec.europa.eu/dyna2/emdn/ available, accessible and transparent
Procurement
Policy or guideline: Yes Website: http://www.pisrs.si/Pis.web/
pregledPredpisa?id=ZAKO7086 Medical device incorporation
National level procurement: Yes Website: https://www.gov.si/drzavni-organi/
The name of the procurement policy is:
ministrstva/ministrstvoza-zdravje/o-ministrstvu/direktorat-za-zdravstveno-ekonomiko/ Zakon o javnem naro_anj (ZJN-3)
sektor-za-investicije-in-javna-narocila/
Donations
Website: —
Density per
population

Unit/Department: Division of Investments and Public Procurement. Unit website: https://www.gov.si/drzavni-organi/
ministrstva/ministrstvo-za-zdravje/o-ministrstvu/direktorat-za-zdravstveno-ekonomiko/sektor-za-investicije-in-javna-narocila/
Contact name: Mr. Smiljan Mekicar Contact email: smiljan.mekicar@gov.si
Website with publically available technical specifications: https://www.enarocanje.si/
Type of inventories available: National functional inventory for medical equipment The inventories website is still in
development and is not yet available to the
Website: — public.

Contacts
Name: Mr. Smiljan Mekicar Name: Dr. Aiga Rurane
Email: smiljan.mekicar@gov.si Email: ruranea@who.int
Name: Momir Radulovi_ Name: —
Email: info@jazmp.si Email: —

Solomon Islands

19.38 50
Lower-Middle
aged 30-70 yrs from 39.20% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
2.1 (157) exports (% of 1.40%
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Equipment Committee.

Unit: —
Website: —
Lists available: No Unfortunately, there are no such lists.
Donation equipment have various brands.
Website: —
e
There is no formalized HTA available
HTA unit/department includes the assessment of medical devices: No and it relies heavily on other institutions
Unit/department: — assessment mechanisms, such as the
WHO.
Website(s): —

Name of regulatory agency: Ministry of Health & Medical Services, Solomon Islands The National Referral Hospital (NHR)
Government. performs most of the procurement,
planning and allocation for the
Website(s): https://solomons.gov.sb/ministry-of-health-medical-services/#division Provincial Hospital. There is a disposable
Contact: — Email: — procurement by the Ministry of Finance.

320
Solomon Islands
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified There is virtually none of this currently in
place.
Website: —

Procurement
Donations The procurement Unit, Ministry of Health &
Policy or guideline: No Website: — Medical Service, has mainly to do with the
finance but no with the technical aspect
Technical specifications of the equipment. The Committee is Ad
Technical specifications to support procurement or donations: No hoc and meets only to allocate equipment
base on Departmental requests.
Website: —
Density per
population


Website: —

Contacts
Name: Mr. Tenneth Dalipanda Name: Dr. Sevil Huseynova
Email: tdalipanda@moh.gov.sb Email: huseynovas@who.int
Name: — Name: —
Somalia

114.62 27
Low
aged 30-70 yrs from 30.40% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—): — (—)
rank:f
High-technology
ICT Development
Index (rank):g

Website: —
Ministry of health responsible for health technology policy implementation: National Medicines Regulatory Authority.

Unit: —
Website: —
Website: —
e
Designated unit/department for health technology assessment (HTA):δ Yes National Medicines Regulatory Authority
HTA unit/department includes the assessment of medical devices: Yes (NMRA) under Department of Medical
Services has an HTA role. However, even
Unit/department: National Medicines Regulatory Authority (NMRA): Department if the designated unit is present in the
Medical Services. organigram is not yet well established.
There are scarce HTA activities, but
Website(s): — the plans are to expand, specially in
pharmaceutics. The UHC country goal is in
Contact: Mr. Saed Nuh Ahmed Email: saednux@gmail.com progress.

Name of regulatory agency: National Medicines Regulatory Authority. —
Website(s): https://moh.nomadilab.org/policy-planing/
Contact: Mr. Saed Nuh Ahmed Email: saednux@gmail.com
Health Somalia, Department of Public Health; Ministry of Energy & Water Resources.
Other agency’s website: https://moh.nomadilab.org/1181-2/
https://moewr.gov.so/
322
Somalia
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed The definition of medical devices is
Use: For regulatory purposes included in the national medicines law
which is not yet ratified.
Website: —

Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: Mr. Saed Nuh Ahmed Name: Dr. Mamunur Md Sk Malik
Email: saednux@gmail.com Email: malikm@who.int
Name: Mr. Hassan Elmi Name: Dr. Hassan Mohamed Elmi
Email: elmih@som.emro.who.int Email: lmih@who.int
South Africa

32.22 67
Upper-Middle
1.4%
aged 30-70 yrs from 24.10% >10% (>25%) of
(0.1%)
income (%):i
Human Development
0.71
Years

(0.47): 32.7 (60)
high
rank:f
High-technology
ICT Development
5 (92) exports (% of 5.50%
Index (rank):g

Website: https://www.sahpra.org.za/
Ministry of health responsible for health technology policy implementation: Health Technology Directorate.

Lists available: Yes There are no lists of the mentioned
above. The list is only for the private
Unit: Health Technology. sector funders (not the government). The
National Department of Health is engaging
Website: — with the private sector to establish a
Nomenclature systems used for devices and tests: GMDN. national system.
Lists available: Yes Both UMNDS and GMDN have been used.
Website - hospitals: https://www.sahpra.org.za/wp-content/uploads/2020/01/
Classification_Medical_Devices_IVDs_Nov19_v2.pdf
Website - laboratories: https://www.sahpra.org.za/biological-products/
Nomenclature systems used for devices and tests: GMDN.
Lists available: No There are none of the cited lists mentioned
above.
Website: —
e
The institutionalization of a national HTA
HTA unit/department includes the assessment of medical devices: Yes as part of the ongoing National Health
Unit/department: National Health Technology Committee. Insurance (NHI) is in the process towards
the National Department of Health (NDoH)
Website(s): http://www.health.gov.za/ and the Universal Health Care (UHC) goal.
https://www.gov.za/about-government/government-programmes/national-health-
insurance-0?gclid=Cj0KCQjw4v2EBhCtARIsACan3nwMeUvMBkrHmKSJqw8W_
oNCjOvApxawbfpSz6neNv26jGvTw0tyZyEaAk2PEALw_wcB#
Contact: Mr. Sam Bakhane Email: setlhare.bakhane@health.gov.za

Name of regulatory agency: South African Health Products Regulatory Authority The radiation control is now part of the
(SAHPRA). tasks of the South African Health Products
Website(s): www.sahpra.org.za Regulatory Authority (SAHPRA).
Contact: Ms. Andrea Julsing Email: andrea.julsing@org.za

Name(s) of other regulatory agency eg. for radiation equipment etc.: Directorate of
Radiation Control.
Other agency’s website: www.sahpra.org.za
https://nnr.co.za/
http://www.necsa.co.za/
324
WHO African Region
South Africa
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: The regulator has adopted the use of
For regulatory purposes GMDN which will be a nationally accepted
nomenclature.
Website: —

Procurement
Policy or guideline: Yes Website: www.treasury.gov.za
http://www.treasury.gov.za/legislation/pfma/Default.aspx Medical device incorporation
http://www.treasury.gov.za/legislation/pfma/Default.aspx comments (...Annex 1):
The Office of the Chief Procurement
National level procurement: No Website: — Officer is in charge of the procurement of
Donations medical devices.
Website: www.treasury.gov.za
Density per
population


Unit/Department: Health Technology Policy. Unit website: —
Contact name: Mr. Sam Bakhane Contact email: setlhare.bakhane@health.gov.za
Website with publically available technical specifications: www.treasury.gov.za
Type of inventories available: None There are no national inventory nor
management systems but some hospitals
Website: — do have. Currently, we are compiling a
Use of management software: Yes Software name: — national inventory and acquiring a system
to be implemented at a national level. Thus,
we are progressing to acquire the national
system.
Contacts
Name: Mr. Sam Setlhare Bakhane Name: Dr. Owen Laws Kaluwa
Email: setlhare.bakhane@health.gov.za Email: kaluwao@who.int
Name: Mr. S. du Plessis Name: Dr. Habib Somanje
Email: duples@fshealth.gov.za Email: somanjeha@who.int
South Sudan

97.86 32
Low
aged 30-70 yrs from 16.80% >10% (>25%) of — (—)
income (%):i
Human Development
0.43
Years

(0.28): — (—)
low
rank:f
High-technology
ICT Development
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): —
326
WHO African Region
South Sudan
Website: —

Procurement
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: — Name: Dr. Olushayo Olu
Email: — Email: afwcosswho@who.int
Name: — Name: —
Spain

3.25 86
High
5.7%
aged 30-70 yrs from 9.60% >10% (>25%) of
(1.2%)
income (%):i
Human Development
Years

45.6 (30)
rank:f
High-technology
ICT Development
7.8 (27) exports (% of 6.90%
Index (rank):g

Website: http://www.msps.es/organizacion/sns/planCalidadSNS/home.htm
Ministry of health responsible for health technology policy implementation: Agencia de la Calidad en el Sistema Nacional
de Salud.

Unit: Dirección General de Ordenación Profesional, Cohesión del Sistema Nacional
de Salud y Alta Inspección.
Website: —
Website - laboratories: https://www.aemps.gob.es/productos-sanitarios/
productossanitarios_invitro/
Website: —
e
There is a network of Agencies for HTA
HTA unit/department includes the assessment of medical devices: Yes and services of the National Health System.
Unit/department: AETS-ISCIII. The HTA is for decision-making within
the health system, as well as for medical
Website(s): https://www.aemps.gob.es/productos-sanitarios/vigilancia_ products, including medical devices.
productossanitarios/; https://eng.isciii.es/eng.isciii.es/Paginas/Inicio.html
http://www.aetsa.org/; http://aquas.gencat.cat/ca/inici/; http://avalia-t.sergas.es
http://www.bioef.org/

Name of regulatory agency: Agencia Española de Medicamentos y Productos —
Sanitarios (AEMPS).
Website(s): http://www.aemps.es
Contact: Ms. Carmen Abad Luna Email: cabad@aemps.es
Name(s) of other regulatory agency eg. for radiation equipment etc.: Consejo de
Seguridad Nuclear; Ministerio para la Transición Ecológica y el Reto Demográfico.
Other agency’s website: https://www.csn.es/home
328 https://www.miteco.gob.es/en/
WHO European Region
Spain
Donations —
Website: —
Density per
population


Website: https://www.mscbs.gob.es/estadEstudios/estadisticas/sisInfSanSNS/
tablasEstadisticas/InfAnualSNS2016/Informe_Anual_SNS_2016_completo.pdf

Contacts
Name: Mr. Antonio Sarria-Santamera Name: —
Email: asarria@isciii.es Email: —
Name: — Name: —
Sri Lanka

6.93 67
Lower-Middle
5.4%
aged 30-70 yrs from 13.20% >10% (>25%) of
(0.9%)
income (%):i
Human Development
0.78
Years

(0.67): 23.8 (101)
high
rank:f
High-technology
ICT Development
3.9 (117) exports (% of 1.00%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: https://nmra.gov.lk/index.php?option=com_
devices&view=devices&Itemid=224&lang=en
Website - hospitals: https://nmra.gov.lk/images/PDF/Legislation/5e_nmdra_07.pdf
http://www.health.gov.lk/moh_final/english/hospital_government.php?spid=24
Website - laboratories: https://nmra.gov.lk/index.php?option=com_
devices&view=devices&Itemid=224&lang=en
Website: —
e
The institutionalizing of an HTA as a
HTA unit/department includes the assessment of medical devices: No mechanism for promoting health system
Unit/department: — integrity is in early stages.
Website(s): —

Name of regulatory agency: Cosmetics, Devices and Drugs Authority. —
Website(s): http://www.health.gov.lk
Contact: Dr. H. Beneragama Email: —
Medicines Regulatory Authority.
Other agency’s website: https://nmra.gov.lk/index.php?lang=en
330
Sri Lanka
Not specified
Website: —

Procurement
Donations —
Website: —
Density per
population

Unit/Department: Division of Biomedical Services. Unit website: —
Website: —
Use of management software: Yes Software name: VH Temp.

Contacts
Name: Mr. J.M.L.K. Jayathilake Name: Dr. Alaka Singh
Email: mudithaj@hotmail.com Email: singha@who.int
Name: Dr. Terance Name: —
Sudan

56.58 44
Low
aged 30-70 yrs from 22.80% >10% (>25%) of — (—)
income (%):i
Human Development
0.51
Years

(0.33): — (—)
low
rank:f
High-technology
ICT Development
2.6 (145) exports (% of —
Index (rank):g

Website: —
Ministry of health responsible for health technology policy implementation: Health Development Unit.

Unit: —
Website: —
Website - hospitals: http://www.nmpb.gov.sd/en/lic_lap_pharm.php
Website - laboratories: http://www.nmpb.gov.sd/en/lic_lap_pharm.php
Website: —
e
A Health Technology Management system
HTA unit/department includes the assessment of medical devices: No (HTM) has been developed. However, there
Unit/department: — is not current HTA system in place, but it
is a goal to pursue towards the Universal
Website(s): — Health Care country goal.

Name of regulatory agency: National Medicine and Poison Board. —
Website(s): http://www.nmpb.gov.sd/
Contact: Dr. Mohamed Elhassan Mohamed Ahmed Email: —
Name(s) of other regulatory agency eg. for radiation equipment etc.: Sudanese
Nuclear and Radiological Regulatory Authority; National Medicines and Poisons
Board (NMPB).
Other agency’s website: http://www.snrra.gov.sd/English/index.php
http://www.nmpb.gov.sd/imp_device.php
332
Sudan
Website: —

Procurement
Donations —
Website: —
Density per
population

Unit/Department: Medical Engineering Unit/ Curative Medicine Department. Unit website: —
Contact name: Eng. Fatima Mohamed Fadol Contact email: —
Website: —

Contacts
Name: Mr. Mohamed Osman Hamid Name: Dr. Nima Saeed Abid
Email: osmanhamid72@gmail.com Email: abidn@who.int
Name: Eng. Fatima Mohamed Fadol Name: Dr. Nahid Idris Salih Khalid
Email: — Email: salihn@sud.emro.who.int
Suriname

17.57 67
Upper-Middle
4.9%
aged 30-70 yrs from 22.70% >10% (>25%) of
(1.4%)
income (%):i
Human Development
0.74
Years

(0.54): — (—)
high
rank:f
High-technology
ICT Development
5.2 (88) exports (% of 12.50%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
—
Website(s): —

Website(s): http://health.gov.sr/
Contact: Secretariat of the Director of Health Email: secdir.volksgezondheid@gov.sr
334
Suriname
Website: —

Procurement
Donations —
Website: —
Density per
population

Website: —

Contacts
Name: Mrs. Mellenie Kasanredjo Name: Dr. Karen Lewis-Bell
Email: mellenie.saimoen@gov.sr Email: lewisbek@paho.org
Name: — Name: Dr. Rosmond Adams
Email: — Email: adamsros@paho.org
Sweden

2.64 87
High
aged 30-70 yrs from 8.40% >10% (>25%) of — (—)
income (%):i
Human Development
0.95
Years

(0.88): 62.5 (2)
very high
rank:f
High-technology
ICT Development
8.4 (11) exports (% of 14.60%
Index (rank):g

Website: https://www.government.se/government-of-sweden/ministry-of-health-and-social-affairs/
Language(s): —

Lists available: No The devices must bear the CE-mark.
Unit: —
Website: —
Lists available: No There is an ongoing project in order to
create such a national list. It is the Dental
Website: — and Pharmaceutical Benefits Agency that
is working with that.
e
Network of HTA agencies such as: the
HTA unit/department includes the assessment of medical devices: Yes Dental and Pharmaceutical Benefits
Unit/department: The Dental and Pharmaceutical Benefits Agency. Agency (TLV); Agency for the HTA and
Assessment of Social Services (SBU), and
Website(s): https://www.tlv.se/medicinteknik.html Medical Products Agency. Alternative
https://lakemedelsverket.se/english/ email: registrator@tlv.se.
https://www.sbu.se/en/
Contact: Ms. Karin Melén Email: Karin.Melen@tvl.se

Name of regulatory agency: Medical Products Agency. —
Website(s): http://www.lakemedelsverket.se/english/
Contact: Ms. Malin Blixt Email: registrator@mpa.se
Name(s) of other regulatory agency eg. for radiation equipment etc.: Swedish
Radiation Safety Authority.
Other agency’s website: https://www.stralsakerhetsmyndigheten.se/en/
336
WHO European Region
Sweden
Donations The national law for procurement is
Policy or guideline: No Website: — based on the EU directive. Concerning
procurement, it can be done at a country
Technical specifications level or within a single hospital.
Website: —
Density per
population


Website: —

Contacts
Name: — Name: —
Name: — Name: —
Switzerland

4 87
High
aged 30-70 yrs from 7.90% >10% (>25%) of — (—)
income (%):i
Human Development
0.96
Years

(0.89): 66.1 (1)
very high
rank:f
High-technology
ICT Development
8.7 (3) exports (% of 12.90%
Index (rank):g

Website: —
Language(s): —

Lists available: Yes Reimbursement list for medical devices
used by the patients themselves, and
Unit: Swiss Federal Office of Public Health. Reimbursement list for medical analyses
are available on the corresponding website
Website: https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung. (see link).
html
Website: —
e
There is the swiss network of HTA entities
HTA unit/department includes the assessment of medical devices: Yes focusing in various areas. Some institutions
Unit/department: Health and Accident Insurance Directorate. are: Health Insurance Benefits, State
Secretariat for Education, Research and
Website(s): http://www.snhta.ch/ Innovation, etc.
https://www.bag.admin.ch/bag/en/home/versicherungen/krankenversicherung/
krankenversicherung-bezeichnung-der-leistungen/re-evaluation-hta.html
https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel.html
Contact: — Email: ELGK-sekretariat@bag.admin.ch

Name of regulatory agency: Swiss Agency for Therapeutic Products (Swissmedic). —
Website(s): https://www.swissmedic.ch/swissmedic/en/home/
Contact: Dr. Karoline Mathys Badertscher Email: Karoline.Mathys@swissmedic.ch
Name(s) of other regulatory agency eg. for radiation equipment etc.: Swiss Federal
Nuclear Safety Inspectorate (ENSI); Federal Office of Public Health (FOPH).
Other agency’s website: https://www.ensi.ch/en/
https://www.bag.admin.ch/bag/en/home.html
338
WHO European Region
Switzerland
C3D4 Official nomenclature system for medical devices: Yes Type: More than one system Swissmedic uses GMDN (no country
Use: Not specified specific nomenclature), if manufacturers
do not know the GMDN number, a UMDNS
Website: — code may be given.

Procurement
The medical devices must fulfil the
Policy or guideline: No Website: — requirements described in the European
National level procurement: No Website: — medical device directives. Legal basis
(Swiss Medical devices ordinance): http://
Donations www.admin.ch/ch/d/sr/c812_213.html.
Policy or guideline: No Website: — The hospital / high cost technology
planning is done at a national level.
Technical specifications Coordinated planning of certain highly
Technical specifications to support procurement or donations: Yes specialized areas of health care is in
progress (see https://www.gdk-cds.ch/
Publically available: — de/).
Website: —
Density per
population


Type of inventories available: National inventory only for high cost technologies Go to the gdk website and search for the
291.0.html documentation.
Website: https://www.gdk-cds.ch/de/; https://www.gdk-cds.ch/fileadmin/docs/public/
gdk/themen/spitalfinanzierung/GDK-UEbersicht_Spitallisten_Spitaltarife.pdf

Contacts
Name: Mr. André Breisinger Name: —
Email: questions.devices@swissmedic.ch Email: —
Name: — Name: —
Syrian Arab Republic

22.4 56
Low
aged 30-70 yrs from 22.10% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
3.3 (126) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
It exists the Planning and International
HTA unit/department includes the assessment of medical devices: — Collaboration Directorate which performed
Unit/department: — HTA activities, but it is not specifically for
medical devices.
Website(s): —

Website(s): —
Name(s) of other regulatory agency eg. for radiation equipment etc.: Syrian Atomic
Energy Commission.
Other agency’s website: http://www.aec.org.sy/
340

Website: —

Procurement
Donations —
Website: —
Density per
population

Website: —

Contacts
Name: — Name: Dr. Akjemal Magtymova
Email: — Email: magtymova@who.int
Name: — Name: —
Tajikistan

32.28 66
Lower-Middle
aged 30-70 yrs from 28.30% >10% (>25%) of — (—)
income (%):i
Human Development
0.67
Years

(0.58): 22.2 (109)
medium
rank:f
High-technology
ICT Development
Index (rank):g

Website: https://adbmch.tj/en/home/
http://www.pharmnadzor.tj/index.html
Language(s): —

Unit: —
Website: —
Website - hospitals: http://ncl.tj/
Website: —
e
—
Unit/department: Medical Devices Unit.
Website(s): —

Name of regulatory agency: State Supervision Service for Pharmaceutical Activities —
of the Republic of Tajikistan; Agency of Standardization, Metrology, Certification
and Trade Inspection under the Government of Republic of Tajikistan.
Website(s): https://adbmch.tj/en/home/
http://www.pharmnadzor.tj/
http://www.standard.tj/
Name(s) of other regulatory agency eg. for radiation equipment etc.: Agency on Nuclear and Radiation Safety, National
Academy of Sciences of Tajikistan.
Other agency’s website: https://anrt.tj/en/research-institutes/division-of-physical-mathematical-chemical-geological-and-technical-
sciences/agency-on-nuclear-and-radiation-safety
342
WHO European Region
Tajikistan
C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: —
Website: https://portal.eaeunion.org/sites/odata/redesign/Pages/
MedicalDeviceNomenclature.aspx

Procurement
Donations —
Website: —
Density per
population

Unit/Department: Medical Devices Unit. Unit website: http://www.pharmnadzor.tj/
Website: https://adbmch.tj/en/home/

Contacts
Name: Mr. Salim Abdulazizov Name: Dr. Victor Stefan Olsavszky
Email: abdu_salim@mail.ru Email: olsavszkyv@who.int
Name: — Name: —
Thailand

8.65 83
Upper-Middle
2.2%
aged 30-70 yrs from 13.70% >10% (>25%) of
(0.4%)
income (%):i
Human Development
0.78
Years

(0.65): 36.7 (44)
high
rank:f
High-technology
ICT Development
5.7 (78) exports (% of 23.60%
Index (rank):g

Website: https://www.moph.go.th/
Language(s): Thai
Ministry of health responsible for health technology policy implementation: Food and Drugs Administration.

Lists available: Yes There are lists of recommended
procedures in organization level such as
Unit: 1. National Health Security Office, 2.The Comptroller General’s Department, the procedure of the Physical Therapy
3.Social Security Office. Council. The approved medical devices list
is only available for the reimbursements
Website: — of the three health insurances, namely
Lists available: No There are lists of recommended
procedures in organization level such as
Website: — the procedure of the Physical Therapy
Council.
e
HTA is focused on several health
HTA unit/department includes the assessment of medical devices: Yes technologies and programs, including
Unit/department: Health Intervention and Technology Assessment Program (HITAP) pharmaceuticals, medical devices,
interventions, and disease prevention as
Website(s): https://www.hitap.net/en/organization/background well as to inform policy decisions.
Contact: Dr. Pongpan Vongmanee Email: pongpan_v@fda.moph.go.th

Name of regulatory agency: Food and Drug Administration. The Office of Atoms for Peace (OAP),
Website(s): https://www.moph.go.th/index.php/search within the Ministry of Science and
Technology, is the responsible agency
http://www.fda.moph.go.th/eng/medical/index.stm for strengthening regulatory control
Contact: Dr. Pongpan Vongmanee Email: pongpan_v@fda.moph.go.th of sources that involve radioactive
activities such as manufacturing, radiation
Name(s) of other regulatory agency eg. for radiation equipment etc.: Office of processing, radiation application (medical,
Atoms for Peace, Ministry of Science and Technology. industrial, research, etc.), importation and
exportation of radioactive sources and
Other agency’s website: https://most.go.th/main/en radioactive waste management under the
http://www.nst.or.th/en/index.html Atomic Energy for Peace Law, BE2504
(1961) and the Nuclear Energy for Peace
344
Thailand
Website: —

Procurement
Policy or guideline: Yes Website: https://www.moph.go.th/
Donations The procurement was performed by
Policy or guideline: Yes Website: http://www.moph.go.th individividual agencies. For technical
specifications go to the web site and
Technical specifications find the law section, search for the
Technical specifications to support procurement or donations: Yes corresponding documents.

Website: https://www.moph.go.th/index.php/
Density per
population


Website: —
Use of management software: Yes Software name: RMC2005.

Contacts
Name: Mr. Chapon Ratanapan Name: Dr. Jos Vandelaer
Email: sonapan@fda.moph.go.th Email: vandelaerjo@who.int
Name: Dr. Orasa Kovindha Name: —
Email: kovindha@yahoo.com Email: —
Timor-Leste

42.27 53
Lower-Middle
2.9%
aged 30-70 yrs from 20.00% >10% (>25%) of
(0.5%)
income (%):i
Human Development
0.61
Years

(0.44): — (—)
medium
rank:f
High-technology
ICT Development
3.6 (122) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Lists available: Yes There is the Standart Medical Equipment
from Australia Advissor of Medical
Website: — Equipment. See Clasification Minimum
Standard equipment HP, CHC, DHC.
e
—
Website(s): —

Website(s): —
346
Timor-Leste
Website: —

Procurement
Donations —
Website: —
Density per
population


Type of inventories available: National inventory for medical equipment The Inventory is from 2002-2009.
Website: —

Contacts
Name: — Name: Dr. Arvind Mathur
Email: — Email: mathura@who.int
Name: Mr. Herculano da Silva Name: —
Email: egarggon_011105@yahoo.com Email: —
General comments (...Annex 1): The Health Technology of medical equipment does not have standards for
Medical Equipment yet.
Togo

64.38 44
Low
aged 30-70 yrs from 23.90% >10% (>25%) of — (—)
income (%):i
Human Development
0.52
Years

(0.35): 18.5 (125)
low
rank:f
High-technology
ICT Development
2.2 (156) exports (% of 0.10%
Index (rank):g

Website: —
Language(s): —

Lists available: No Aucune organisation en charge de ces
listes existe, malgré toutes les propositions
Unit: — formulées dans ce sens. Il ne semble pas
avoir la volonté politique à évoluer dans
Website: — ce sens.
Website: —
e
—
Website(s): —

Website(s): —
348
WHO African Region
Togo
C3D4 Official nomenclature system for medical devices: No Type: None Use: Not specified Le niveau du sous service chargé chargé
des équipements est trop bas pour être
Website: — lisible. Les supérieurs hiérarchique ne
portent pas l’intérêt nécessaire pour la
mise en oeuvre de la gestion qui s’impose
Medical device incorporation pour les dispositifs médicaux.
Procurement
Donations La politique suivi en terme d’achat de
Policy or guideline: No Website: — dispositif est celle du code des marchés
publiques. L’achat ne se fait au niveau
Technical specifications central que si l’Etat définit ponctuellement
Technical specifications to support procurement or donations: No un programme d’intervention suite à une
urgence nationale.
Website: —
Density per
population


Unit/Department: Service de la Maintenance. Unit website: —
Contact name: Mr. Komlan Jean Edoh-kossi Contact email: kedohkos@yahoo.fr
Type of inventories available: None Bien que cela soit le point de départ de
toute gestion en terme de maintenance
Website: — des parcs biomédicaux, cette opération
Use of management software: No Software name: — n’existe pas au plan national sauf par
endroit mais aussi de façon sommaire . Les
données ainsi consignées ne permettent
pas de l’exploiter pour proposer des plans
de renouvellement ou de developpement
Number of biomedical/clinical engineers professionals in the country:γ — de parcs biomédicaux. En bref aucun
inventaire digne de ce nom n’existe pas sur
le plan national.
Contacts
Name: — Name: Dr. Fatoumata Binta T. Diallo
Email: — Email: diallof@who.int
Name: Mr. Komlan Jean Edoh-kossi Name: Dr. Minzah Pekele
Email: kedohkos@yahoo.fr Email: pekelem@who.int
General comments (...Annex 1): Compte tenue des difficultés que nous rencontrons pour la prise en compte
adéquate des plateaux techniques dans nos formations sanitaires malgré les recommandations régionales pour une
politique commune en matière de maintenance et la gestion durable des infrastructures sociales je veux bien croire que
cette enquète nous ouvrira l’ horizon de nouvelles politiques adptées à nos réalités.
Tonga

11.41 56
Upper-Middle
aged 30-70 yrs from 24.80% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
4.3 (110) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: Facility and Equipment Committee together with the Biomedical Engineering
Unit of the Ministry of Health.
Website: —
Lists available: No There are no specific lists.
Website: —
e
—
Website(s): —

Name of regulatory agency: — Although there is no formal institution
Website(s): — that oversees the implementation of any
medical device regulation, there is the
Contact: Mr. Feleti Eke Email: feke@health.gov.to “Facility and Equipment Committee”
of the Ministry of Health that oversees
Name(s) of other regulatory agency eg. for radiation equipment etc.: — certain things such as the procurement
Other agency’s website: — of medical devices, the criteria of
acceptance of donated equipment and the
implementation of maintenance guidelines,
etc.
350
Tonga
Website: —

Procurement
Donations —
Website: —
Density per
population
Mammograph:α,* 0 0
Radiotherapy:β 0 0

Unit/Department: Biomedical engineering. Unit website: —
Contact name: Mr. Feleti Eke Contact email: feke@health.gov.to
Website: —
Use of management software: Yes Software name: Equipment Management
Systems.

Contacts
Name: — Name: Dr. Yutaro Setoya
Email: — Email: setoyay@who.int
Name: Mr. Feleti Eke Name: —
Email: feke@health.gov.to Email: —
Trinidad and Tobago

16.6 73
High
3.9%
aged 30-70 yrs from 17.10% >10% (>25%) of
(1.9%)
income (%):i
Human Development
Years

24.1 (98)
rank:f
High-technology
ICT Development
6 (68) exports (% of —
Index (rank):g

Website: http://www.health.gov.tt/

Lists available: Yes, but it is only a recommendation The nomenclature is part of the
Computerized Maintenance Management
Unit: Ministry of Health. System.
Website: —
Nomenclature systems used for devices and tests: Other.
Lists available: Yes Certification standards for equipment, e.g.
European CE Marking and U.S. Food and
Website - hospitals: — Drug Administration.
The list exists for point of care testing
Lists available: Yes equipment, namely, Diagnostic Screening
Website: — and Laboratory Testing. The medical
equipment requirements for specific
procedures are done by the respective
e
National health technology assessment unit inhouse Hospital Biomedical Department
There are identified HTA activities at a
HTA unit/department includes the assessment of medical devices: No national level. Furthermore a consultant
Unit/department: is to be engaged to assists in the
development of an HTA framework.
Website(s): — Alternative contact for the Health
Contact: Mr. Kyron Lopez Email: kyron.lopez@health.gov.tt Technology Management unit: pmu@
health.gov.tt.

Name of regulatory agency: Chemistry Food and Drug Division. —
Website(s): http://www.health.gov.tt
http://www.health.gov.tt/sitepages/default.aspx?id=93
Contact: Mr. Adrian Mc Cathy Email: adrianmccathy@health.gov.tt
352
Trinidad and Tobago

C3D4 Official nomenclature system for medical devices: No Type: More than one system Developed and in use as “Fixed Assest
Use: For procurement purposes Inventory and Facilities Management”.
TMA Systems Maintenance Management
Website: — Software (the nomenclature of medical
devices are generally developed by the
respective Regional Health Authorities
Medical device incorporation for procurement purposes). The Ministry
of Health of Trinidad and Tobago has
Procurement established that no specific or official
Policy or guideline: Yes Website: — nomenclature system is used in this
National level procurement: No Website: — Medical device incorporation

Donations There are guidelines based on the Regional
Policy or guideline: Yes Website: — Health Authorities (RHAs) internal policies
and procedures on the procurement
Technical specifications process and in particular for the need
Technical specifications to support procurement or donations: Yes of the development of specifications.
The Ministry of Health is presently
Publically available: — moving towards standardising policies
Website: — and procedures for all technical areas
which would include the procurement of
medical devices. Technical specifications
Density per are developed as part of all equipment
Medical equipment Total 1,000,000 procurement for public open tender.
population In general, there are recommended
technical specifications used by each
Magnetic Resonance Imaging:α 7 5 RHA for procurement of equipment as
part of public tendering requirements.
This is an area that the ministry is working
Computerized Tomography Scanner:α 12 8.58 with the RHAs towards standardising.
For procurement information contact
Positron Emission Tomography Scanner:α 1 0.71 via mail to pmu@health.gov.tt (Project
Management Unit).

Unit/Department: Biomedical Department, North Central Regional Health Authority. Unit website: —
Contact name: Mr. Rusell Sooknanan Contact email: russel.sooknanan@ncrha.co.tt
Type of inventories available: National inventory only for high cost technologies The inventories of other medical devices
exist at each respective Regional Health
(Diagnostic Imaging) Authorities (RHA) and for high-cost
Website: — technologies such as diagnostic imaging.
Use of management software: Yes Software name: WebTMA.

Contacts
Name: Mr. Ronald Koylass Name: Dr. Erica Lynette Wheeler
Email: Ronald.Koylass@health.gov.tt Email: wheelereri@paho.org
Name: Mr. Rusell Sooknanan Name: Dr. Paul Edwards
Email: russel.sooknanan@ncrha.co.tt Email: edwardsp@paho.org
General comments (...Annex 1): It is noted that several medical devices systems exist at the respective Regional
Health Authorities (RHA) level. The MoH is currently working towards standardising these and in particular concerning the
procurement guidelines for medical devices.
Tunisia

16.62 70
Lower-Middle
18.4%
aged 30-70 yrs from 15.70% >10% (>25%) of
(2.7%)
income (%):i
Human Development
Years

31.2 (65)
rank:f
High-technology
ICT Development
4.8 (99) exports (% of 6.90%
Index (rank):g

Website: —
Language(s): —

Lists available: No L’acquisition et la mise en service des
equipements lourds sont soumis a
Unit: — l’autorisation préalable du MoH pour
les secteurs publique et privé et ce
Website: — conformément aux critères et normes
Nomenclature systems used for devices and tests: — fixés par les arrêtés sus-indiqués. -Arrêté.
National list for specific clinical interventions/emergencies: L’acquisition et la mise en service des
Lists available: Yes equipements lourds sont soumis a
Website: http://www.santetunisie.tn/images/docs/pop-up3.html l’autorisation préalable du Ministère
de la santé publique pour les secteurs
publique et privé et ce conformément aux
e
National health technology assessment unit critères et normes fixés par les arrêtés
INEAS is under the auspices of the
HTA unit/department includes the assessment of medical devices: Yes MoH. It evaluates health technologies
Unit/department: — and provide rigorous evidence-based
recommendations to decision-makers on
Website(s): https://www.ineas.tn/fr pharmaceuticals and other technologies’
Contact: — Email: — uptake and use. As one internal policy
trains it’ s own staff, as well as HTA user’s.

Website(s): http://www.santetunisie.rns.tn/fr/
Name(s) of other regulatory agency eg. for radiation equipment etc.: Centre
National des Sciences et Technologies Nucléaires (CNSTN) et Centre National
Chalbi Belkahia de Pharmacovigilance (CNPV).
Other agency’s website: http://www.cnstn.rnrt.tn/radioprotection.php
http://www.pharmacovigilance.rns.tn/
354
Tunisia
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed La nomenclature des dispositifs médicaux
Use: Not specified fait partie intégrante du Manuel des
procédures de gestion de la maintenance
Website: — biomédicale et hospitalière élaboré en
1996 et amélioré en 2007 par le Ministère
de la santé publique qui a fait l’objet d’un
Medical device incorporation arrêté.
Procurement
National level procurement: Yes Website: www.santetunisie.rns.tn
Donations L’achat des dispositifs médicaux obéit
Policy or guideline: No Website: — en plus des procédures réglementaires
(Reglément des marchés publics)
Technical specifications d’unepart et passe par des commissions
Technical specifications to support procurement or donations: Yes techniques spécialisés (commissions
d’elaboration des cahiers des clauses
Publically available: No techniques particulieres, fiches
techniques, commissions de sélection, des
Website: — commissions de réception provisoire et
définitifs du matériel fiches techniques).
Density per Il n’ya pas de fiches techniques standard
Medical equipment Total 1,000,000 mais elles sont préparés au cas par cas
en fonction du besoin (caractéristiques
population opérationnelles).

Unit/Department: Agence Nationale de Contrôle Sanitaire et Environnemental des Produits.
Unit website: http://www.ancsep.rns.tn/
Contact name: Dir. General Contact email: ancsep.@rns.tn
Website with publically available technical specifications: http://www.santetunisie.rns.tn/fr/
Type of inventories available: — Conformément au manuel des procédures
de gestion de la maintenance chaque
Website: — établissement de santé est dans
Use of management software: Yes Software name: G.M.B.H. l’obligation de tenir un inventaire technique
des équipements et des infrastructures
techniques, remplir la fiche d’identification
et une fiche de santé (maintenance) par
appareil. Un applicatif informatique dédiée
Number of biomedical/clinical engineers professionals in the country:γ 20 a été développé à cet effet. Management
Software: G.M.B.H. développé en local par
le cetembh et le centre informatique du
Contacts
Name: Mr. Fathi Amous Name: Dr. Yves Souteyrand
Email: fathi.amous@rns.tn Email: souteyrandy@who.int
Name: Dir. General Name: Dr. Ramzi Ouhichi
Email: ancsep.@rns.tn Email: ouhichir@tun.emro.who.int
General comments (...Annex 1): La structure publique de santé en Tunisie est composé de établissements
publics de santé (CHU,H. Spécialisés) dans les sièges de faculté de médecine des hôpitaux régionaux des hôpitaux de
circonscription des groupements de santé de base des centres de santé de base et des centres régionaux de médecine
scolaire et universitaire en plus des trois hôpitaux militaires et un hôpital des forces de sécurité intérieure publics et six
centres de d’hémodialyse et six polycliniques para-publique ne relevant pas du ministère de la santé le secteur privé
Türkiye

9.49 79
Upper-Middle
3.2%
aged 30-70 yrs from 15.60% >10% (>25%) of
(0.4%)
income (%):i
Human Development
0.82
Years

(0.68): 34.9 (51)
very high
rank:f
High-technology
ICT Development
6.1 (67) exports (% of 3.00%
Index (rank):g

Website: —
Language(s): —

(...Annex 1):
(including IVDs), for procurement or reimbursement:
The Ministry of Health is closely involved
Lists available: Yes in the decision making but the main
Unit: Social Security Institution. responsible unit is the Social Security
Institution of the Republic of Turkey. The
Website: https://www.saglik.gov.tr/TR,10550/turkiye-ilac-ve-tibbi-cihaz-kurumu.html directorate of Curative Services is the main
responsible unit in the Ministry of Health
Website - hospitals: https://www.mevzuat.gov.tr/
mevzuat?MevzuatNo=15023&MevzuatTur=7&MevzuatTertip=5
Website - laboratories: https://www.titck.gov.tr/dinamikmodul/85
National list for specific clinical interventions/emergencies: These standards are not centrally
organized and published. Each
Lists available: Yes department has its own and they can
Website: http://www.saglik.gov.tr be found in the second link under Saglik
Mevzuati>Genelgeler, Tebligler, Yönergeler,
https://www.saglik.gov.tr/TR,10357/saglik-mevzuati.html Yönetmelikler>… Relevant departments
e
Generic email of the HTA department
HTA unit/department includes the assessment of medical devices: Yes shgm.argestd@saglik.gov.tr .
Unit/department: General Directorate of Curative Services.
Website(s): https://shgmargestddb.saglik.gov.tr/
https://www.saglik.gov.tr/
Contact: Mr. Irfan Sencan Email: irfan.sencan@saglik.gov.tr

Name of regulatory agency: Directorate of Pharmacy and Pharmaceuticals —
Department of Medical Device Services.
Website(s): https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz
Contact: Mr. Bilgehan Karadayi Email: bilgehan.karadayi@iegm.gov.tr
Regulatory Authority (NDK); Turkish Medicines and Medical Devices Agency (TITCK).
Other agency’s website: http://ndk.gov.tr/tr/
https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz/tibbi-cihazda-klinik-arastirmalar
356
WHO European Region
Türkiye
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed Huab is the Turkish registry system for
Use: Not specified medical devices. Both GMDN and UNSPSC
are used in this system. For reimbursement
Website: https://www.saglik.gov.tr/?_Dil=2 purposes another nomenclature
mentioned in the corresponding link is also
used.
Procurement
Policy or guideline: Yes Website: https://www.saglik.gov.tr/?_Dil=2
Donations —
Policy or guideline: Yes Website: http://www.saglik.gov.tr/
Website: —
Density per
population


Unit/Department: Directorate of Pharmacy and Pharmaceuticals. Unit website: https://www.hssgm.gov.tr/
Contact name: Mr. Saim Kerman Contact email: saim.kerman@iegm.gov.tr
Website with publically available technical specifications: https://www.hssgm.gov.tr/TuzuklerYonetmelikler
Type of inventories available: National inventory for medical equipment Go to the previous website and search for
sbhbt. However, the full online inventory
Website: http://www.saglik.gov.tr/ databank, with restricted use to the
Use of management software: — Software name: — authorities, is on the following site: http://
sbu.saglik.gov.tr/sbhbf/

Contacts
Name: — Name: Dr. Batyr Berdyklychev
Email: — Email: berdyklychevb@who.int
Name: Mr. Saim Kerman Name: —
Email: saim.kerman@iegm.gov.tr Email: —
General comments (...Annex 1): Concerning the medical equipment and structure section: there is a draft
document (Health Statistics Yearbook) at the link: https://hsgm.saglik.gov.tr/tr/ , but it is not appropiate to use it as a
reference since the original document will be available in the future. Some numbers can be variable because of the
dynamic situation in Turkey. Especially for the last 5-7 years, the health technology situation is changing and developing
rapidly.
Turkmenistan

41.76 73
Upper-Middle
aged 30-70 yrs from 27.70% >10% (>25%) of — (—)
income (%):i
Human Development
0.72
Years

(0.59): — (—)
high
rank:f
High-technology
ICT Development
Index (rank):g

Website: https://www.saglykhm.gov.tm/home
Language(s): —

Unit: —
Website: —
Website: —
e
There is no systematic programme of
HTA unit/department includes the assessment of medical devices: No health technology assessment, but an
Unit/department: — informed decision is mainly used for
pharmaceutics but no for medical devices.
Website(s): —

Name of regulatory agency: Ministry of Health and Medical Industry of —
Turkmenistan.
Website(s): https://www.saglykhm.gov.tm/home
358
WHO European Region
Turkmenistan
Website: —

Procurement
Donations —
Website: —
Density per
population

Website: https://www.saglykhm.gov.tm/home

Contacts
Name: — Name: Dr Egor Zaitsev
Email: — Email: zaitseve@who.int
Name: — Name: —
Tuvalu

22 52
Upper-Middle
aged 30-70 yrs from — >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—): — (—)
rank:f
High-technology
ICT Development
Index (rank):g

Website: —

Unit: —
Website: —
Website: —
e
National Drug and Therapeutic Committee
HTA unit/department includes the assessment of medical devices: No (NDTC) has done HTA activities mainly
Unit/department: — in pharmaceutics; however, there is no a
national HTA unit.
Website(s): —

Website(s): —
Contact: Director of Health Email: pphs@tuvalu.tv
360
Tuvalu
Not specified
Website: —

Procurement
Donations Guidelines on Donations exist, they are
Policy or guideline: Yes Website: — nationally developed but they are not
publicly available.
Website: —
Density per
population


Unit/Department: Biomedical Department of Princess Margaret Hospital. Unit website: —
Contact name: Mr. Nelson Morikao Vaguna Contact email: pphs@tuvalu.tv
Website: —

Contacts
Name: Mr. Nelson Morikao Vaguna Name: Dr. Mark Andrew Jacobs
Email: wallabies.donny@gmail.com Email: jacobsma@who.int
Name: Mr. Natano Elisala Name: —
Email: pharmacyintuvalu@gmail.com Email: —
Uganda

43.32 50
Low
15.3%
aged 30-70 yrs from 21.20% >10% (>25%) of
(3.8%)
income (%):i
Human Development
Years

20.5 (114)
rank:f
High-technology
ICT Development
2.2 (152) exports (% of 3.50%
Index (rank):g

Website: https://www.health.go.ug/
Ministry of health responsible for health technology policy implementation: Health Infrastructure Department.

Lists available: Yes, but it is only a recommendation Usually we use the WHO
recommendations. List of equipment by
Unit: National Advisory Commitee on Medical Equipment (NACME). health care level is available in the website.
Website: www.health.go.ug
Nomenclature systems used for devices and tests: Nationally developed.
Lists available: Yes Standard Medical Equipment list is under
review.
Website - hospitals: https://www.nda.or.ug/medical-devices-guidelines/
Website - laboratories: https://www.nda.or.ug/drug-register-downloads/
Lists available: No There are no national lists recommending
health technology for specific procedures.
Website: — We usually adhere to the World Health
Organization recommendations.
e
HTA unit/department includes the assessment of medical devices: No there is not a national unit.
Unit/department: Health Infrastructure Division.
Website(s): http://www.health.go.ug
Contact: Eng. George Otim Odongcoo Email: otimodongcoo@gmail.com

Name of regulatory agency: National Drug Authority. —
Website(s): https://www.nda.or.ug/
Contact: Mr. Gordon K. Sematiko Email: gsematiko@nda.or.ug
Name(s) of other regulatory agency eg. for radiation equipment etc.: Uganda
National Bureau of Standards.
Other agency’s website: https://www.nda.or.ug/medical-devices/
362
WHO African Region
Uganda
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed See the list of medical equipment by level,
Use: For various purposes and the Standard Medical Equipment Lists
and Specifications by healthcare level
Website: www.health.go.ug are under review (as in sample formats in
the corresponding websites). The main
uses of the nomenclature system are for
Medical device incorporation procurement purposes, and inventory
systems in healthcare facilities.
Procurement
Policy or guideline: Yes Website: www.ppda.go.ug
National level procurement: Yes Website: http://www.health.go.ug
Donations The Ministry acquires resources and
Policy or guideline: Yes Website: http://www.health.go.ug procures in bulk; although for the last 2
years development funds for infrastructure
Technical specifications have been directly allocated to regional
Technical specifications to support procurement or donations: Yes referral hospitals which procure
equipment with the guidance of the
Publically available: No health infrastructure division and national
advisory committee on medical equipment
Website: — (NACME). The Public Procurement and
Disposal of Public Assets Authority (within
Density per the MoH, specified website).
population

Unit/Department: Health Infrastructure Department. Unit website: http://www.health.go.ug
http://mrh.igad.int/production/index_ug
Contact name: Eng. Sitra Mulepo Contact email: sitraik@hotmail.com
Website with publically available technical specifications: https://www.nda.or.ug/medical-devices/
Type of inventories available: National functional inventory for medical equipment Currently, is being updated.
Website: —
Use of management software: Yes Software name: New order for managing
anything data (NOMAD) software.

Contacts
Name: Mr. Sitra Mulepo C. S. Name: Dr. Yonas Tegegn Woldemariam
Email: sitraik@hotmail.com Email: woldemariamt@who.int
Name: Eng. Sitra Mulepo Name: Mr. Joseph N. Mwoga
Email: sitraik@hotmail.com Email: mwogaj@who.int
General comments (...Annex 1): The policy guidelines on donations is at Chapter 5.1.5 of the medical equipment
policy (see documentations). The Medical Equipment Policy is under review.
Ukraine

8.11 73
Lower-Middle
7.8%
aged 30-70 yrs from 25.50% >10% (>25%) of
(0.9%)
income (%):i
Human Development
0.78
Years

(0.73): 36.3 (45)
high
rank:f
High-technology
ICT Development
5.6 (79) exports (% of 5.60%
Index (rank):g

Website: https://moz.gov.ua/uploads/0/691-strategiya.pdf; https://zakon.rada.gov.ua/laws/show/753-2013-%D0%BF#n11
https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text
Language(s): Ukranian
Ministry of health responsible for health technology policy implementation: Department of Regulatory Policy in the
Treatment of Drugs and Products in the Health Care System of the Ministry of Health.

Unit: Department of Medical Care; the Department of Motherhood, and Childhood.
Website: https://moz.gov.ua/ministry-mandates/nakaz-moz-ukraini-vid-19072019--1645-pro-
zatverdzhennja-rozpodilu-medichnogo-virobu-medichni-virobi-dlja-koronarografii-sudi
Website - hospitals: https://moz.gov.ua/dokumenti
https://zakon.rada.gov.ua/rada/show/v0153282-98#Text
Website - laboratories: https://moz.gov.ua/dokumenti
Lists available: — There are many files, namely, the orders
MSS. Orders of the Ministry of Health
Website: — approval of protocols of care for various
diseases.
e
In 2019 was established the national HTA
HTA unit/department includes the assessment of medical devices: Yes within the MoH to power the National
Unit/department: HTA Department State Expert Center (SEC), MoH. Essential Medicines List and to inform the
National Benefits Package towards the
Website(s): https://en.moz.gov.ua/ Universal Health Care. The HTA is focused
https://www.dec.gov.ua/ on a wide range of health products,
interventions, but till now is rarely focused
Contact: Ms Oresta Pinyazhko Email: pinyazhko@dec.gov.ua in medical devices.

Name of regulatory agency: State Administration of Ukraine on Medicinal Products —
(SAUMP).
Website(s): https://en.moz.gov.ua/
https://www.dls.gov.ua/
Contact: Volodymyr Chekalin Email: Chekalin_VV@dls.gov.ua
Name(s) of other regulatory agency eg. for radiation equipment etc.: Ministry of Energy and Environment Protection of
Ukraine
Other agency’s website: https://mepr.gov.ua/en/
364
WHO European Region
Ukraine
Website: https://zakon.rada.gov.ua/rada/show/v0331282-01#Text
https://moz.gov.ua/article/ministry-mandates/nakaz-moz-ukraini-vid-28122019--
2711-pro-zatverdzhennja-nomenklaturi-likarskih-zasobiv-ta-medichnih-virobiv-scho-
zakupovuvatimutsja-za-naprjamami-vikoristannja-bjudzhetnih-koshtiv-u-2020-roci-za-
bjudzhetnimi-programami-kpkvk-2301400

Procurement
National level procurement: Yes Website: https://moz.gov.ua/zakupivli-likiv
Donations Contact: Mr Ivan Zadvornykh, Email:
Policy or guideline: Yes Website: https://en.moz.gov.ua/uploads/0/16-strategy_eng.pdf ivanzadvornykh@gmail.com
Website: —
Density per
population


Unit/Department: Control of Monitoring and Maintenance of State Programs. Unit website: https://moz.gov.ua/
https://www.dls.gov.ua/
Website: https://moz.gov.ua/derzhavnij-reestr-medichnoi-tehniki-ta-virobiv-medichnogo-
priznachennja

Contacts
Name: Dr. Sergei Danilov Name: Dr. Jarno Habicht
Email: sergdanilov@mail.ru Email: habichtj@who.int
Name: Ms. Svetlana Zgonnik Name: Dr. Svitlana Pakhnutova
Email: sz2212@gmail.com Email: pakhnutovas@who.int

United Arab Emirates

6.57 78
High
aged 30-70 yrs from 18.50% >10% (>25%) of — (—)
income (%):i
Human Development
Years

41.8 (34)
rank:f
High-technology
ICT Development
7.2 (40) exports (% of 137.60%
Index (rank):g

Website: https://www.mohap.gov.ae/en/aboutus/Pages/PublicHealthPolicies.aspx
Language(s): —

Unit: —
Website: —
Website: —
e
HTA activities have been identified within
HTA unit/department includes the assessment of medical devices: No the MoH. It exists the Health Authority Abu
Unit/department: — Dhabi, the Dubai Health Authority and the
Department of Health (DoH) but there is
Website(s): https://www.mohap.gov.ae/en/Pages/default.aspx not a national unit. The main activities of
https://www.doh.gov.ae/ the HTA are in health products pricing and
https://www.dha.gov.ae/en/pages/dhahome.aspx reimbursement decisions. Also, the private
sector is playing an increasing role in health
Contact: — Email: — care coverage.

Name of regulatory agency: Ministry of Health & Prevention. —
Website(s): https://www.mohap.gov.ae/en/
Name(s) of other regulatory agency eg. for radiation equipment etc.: Federal
Authority for Nuclear Regulation (FANR) and Department of Health (DOH).
Other agency’s website: https://www.fanr.gov.ae/; www.doh.gov.ae
366

Website: —

Procurement
Donations —
Website: —
Density per
population

Website: —

Contacts
Name: — Name: Dr. Rayana Ahmad Bou Haka
Email: — Email: emuaedesk@who.int
Name: — Name: —
United Kingdom of Great Britain and Northern Ireland

4.21 88
High
1.6%
aged 30-70 yrs from 10.30% >10% (>25%) of
(0.5%)
income (%):i
Human Development
0.93
Years

(0.86): 59.8 (4)
very high
rank:f
High-technology
ICT Development
8.7 (5) exports (% of 23.50%
Index (rank):g

Website: —
Language(s): —

Lists available: No There is no approved list of medical
devices for procurement. However we
Unit: — have lists for communicable and non
communicable diseases, and public
Website: — health emergency situations. Guidance is
Nomenclature systems used for devices and tests: — produced by NICE and CEP which was
Lists available: Yes The Centre for Evidence Based Purchasing
(CEP) website is a portal containing
Website: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market over 600 and therefore too numerous
http://guidance.nice.org.uk/IP?textonly=false; http://www.nice.org.uk/guidance/index. for specific reference in this document.
Please note CEP was disbanded end of
jsp?action=ByType&type=6&status=3&p=off. Also see www.dh.gsi.gov.uk/ce March 2010 but the reports still apply to
e
Evidence-based recommendations
HTA unit/department includes the assessment of medical devices: Yes are developed in a wide range of
Unit/department: National Institute for Health and Care Excellence (NICE). areas: clinical guidelines, diagnostic
technologies, interventional procedures,
Website(s): http://www.nice.org.uk/ cost effectiveness, highly specialised, and
http://awttc.org medical technologies guidance.
http://www.healthcareimprovementscotland.org

Name of regulatory agency: The Medicines and Healthcare products Regulatory The Medicines and Healthcare products
Agency (MHRA). Regulatory Agency (MHRA) are the UK
Competent Authority with respect to the
Website(s): www.mhra.gov.uk; https://www.gov.uk/government/organisations/medicines- safety, quality and performance placed
and-healthcare-products-regulatory-agency on the market by manufacturers in the UK
under the EU Medical Devices Directives.
Contact: — Email: info@mhra.gov.uk
Name(s) of other regulatory agency eg. for radiation equipment etc.: Office for Nuclear Regulation (ONR); Department
for Business, Energy & Industrial Strategy, Health and Safety Executive, Office for Nuclear Regulation; Medicines and
Healthcare products Regulatory Agency (MHRA).
Other agency’s website: www.onr.org.uk
368 https://www.gov.uk/guidance/regulatory-controls-for-radiation-protection-in-the-uk
WHO European Region
United Kingdom of Great Britain and Nor thern Ireland

C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: The Medicines and Healthcare products
Not specified Regulatory Agency (MHRA) will be
moving forward to use solely the GMDN
Website: http://www.mhra.gov.uk/Howweregulate/Devices/Registrationofmedicaldevices/ with their system being phased out.
index.htm; www.nhseclass.nhs.uk The nomenclature used by the National
Health System (NHS) for the procurement
of medical devices is that used by the
Medical device incorporation “Official Journal of the European Union”
(OJEU) CPV codes. The NHS also has a
Procurement national system known as “e-class” which
Policy or guideline: Yes Website: https://www.gov.uk/guidance/register-medical-devices-
to-place-on-the-market Medical device incorporation
National level procurement: Yes Website: http://www.supplychain.nhs.uk
Medical devices may be procured at
http://www.nhsnss.org a number of levels, either locally (NHS
Donations Trust level), regionally (collaborative
procurement hub level) or nationally (NHS
Policy or guideline: Yes Website: — Supply chain). Also in Scotland, there is a
system for National Procurement for the
Technical specifications NHS.
Website: https://www.gov.uk/government/publications/technical-specifications-for-personal-protective-equipment-ppe/essential-
technical-requirements-for-ppe-medical-devices-further-information-for-health-and-social-care-providers
Density per
population


Type of inventories available: None A recent amendment of the Medical
Devices Directive has lifted the
Website: — confidentiality requirement on information
Use of management software: — Software name: — supplied by manufacturers to Competent
Authorities under their obligation to
register certain types of medical devices.
The devices include low-risk class I, devices
CE marked based on a self-declaration of
Number of biomedical/clinical engineers professionals in the country:γ 3500 conformity by the manufacturer, custom-
made devices made according to a
prescription from a healthcare professional
Contacts
Name: — Name: —
General comments (...Annex 1): Concerning the HT national policy, it was provided the following document: http://
www.president.gov.ua/docs/Programa_reform_FINAL_1.pdf; www.rada.gov.ua. The UK comprises 4 devolved administrations:
England, Wales, Northern Ireland and Scotland. Each Administration is responsible for the delivery of its own healthcare
system as well as collating and maintaining its own data. Therefore, there is no centrally held data that covers the whole of
the UK. A range of initiatives around the more widespread use of clinically and cost-effective medical devices is underway.
The work is in early stages but once fully operational should improve patients’ access to the latest health technologies.
United Republic of Tanzania

48.87 46
Lower-Middle
3.8%
aged 30-70 yrs from 17.40% >10% (>25%) of
(1.2%)
income (%):i
Human Development
Years

25.6 (88)
rank:f
High-technology
ICT Development
1.8 (165) exports (% of 6.90%
Index (rank):g

Website: https://www.moh.go.tz/en/
Ministry of health responsible for health technology policy implementation: Diagnostic Services, Healthcare Technical
Services under Directorate of Curative Services.

Lists available: Yes Lists recommending health techonology
for different categories of diseases is not
Unit: Tanzania Food and Drugs Authority. available. The Ministry is however planning
to develop it. Registration of medical
Website: https://www.tmda.go.tz/publications/39 devices in Tanzania has started in January
Nomenclature systems used for devices and tests: — 2010. Registration will be carried out
Lists available: No Lists recommending health techonology
for different categories of diseases are not
Website: — available. However, the Ministry is planning
to develop it.
e
The institutionalizing of HTA for decision
HTA unit/department includes the assessment of medical devices: No making and priority setting for guidelines,
Unit/department: — essential medicines list, and cost-effective
treatments is in progress. The Tanzania
Website(s): — HTA committee (THTAC) is essential in the
Contact: — Email: — progress towards the Universal Health Care
country goal.

Name of regulatory agency: Tanzania Food and Drugs Authority (TFDA). —
Website(s): https://www.tmda.go.tz/
Name(s) of other regulatory agency eg. for radiation equipment etc.: Tanzania
Atomic Energy Commission.
Other agency’s website: https://taec.go.tz/inspection-information/
370
WHO African Region

C3D4 Official nomenclature system for medical devices: Yes Type: More than one system TMDA is using GMDN as the nomenclature
Use: For various purposes system for the registration of medical
devices in Tanzania. The main types
Website: — of nomenclature used are GMDN
and UMDNS. The main uses of the
nomenclature system are for procurement
Medical device incorporation purposes and inventory systems in
healthcare facilities.
Procurement
Policy or guideline: Yes Website: https://trade.business.go.tz/media/THE%20
TANZANIA%20FOOD,%20DRUGS%20AND%20COSMETICS(%20medical%20device)%20 Medical device incorporation
regulation.pdf comments (...Annex 1):
Medical Store Department (MSD) is
National level procurement: Yes Website: https://www.moh.go.tz/en/departments/ responsible for procuring pharmaceuticals
procurement and medical devices for the public but
not for profit organization. It should also
Donations be noted that individual entities can also
Policy or guideline: Yes Website: — procure medical devices on their own as
not all devices are covered by MSD. The
Technical specifications private sector imports medical devices
Technical specifications to support procurement or donations: No after obtaining approval from TFDA. The
Website: —
Density per
population

Unit/Department: Healthcare Technical Services. Unit website: —
Contact name: Mr. Valentino Mvanga Contact email: vmvanga@yahoo.com
Website: —

Contacts
Name: Mr. Valentino Mvanga Name: Dr. Tigest Ketsela Mengestu
Email: valentino.mvanga@afya.go.tz Email: ketselat@who.int
Name: — Name: Ms. Rose Shija Muhangwa
Email: — Email: shijar@who.int
United States of America

6.35 83
High
4.8%
aged 30-70 yrs from 13.60% >10% (>25%) of
(0.8%)
income (%):i
Human Development
0.93
Years

(0.81): 60.6 (3)
very high
rank:f
High-technology
ICT Development
8.2 (16) exports (% of 19.00%
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
Designated unit/department for health technology assessment (HTA):δ No There is not a single body nor a national
institution to evaluate health technologies.
HTA unit/department includes the assessment of medical devices: No However, there is an extensive network
of HTA institutions such as the Advisory
Unit/department: — Committee on Immunization Practices
Website(s): https://www.ahrq.gov/research/findings/ta/index.html (ACIP), the Preventive Services Task
Force (USPSTF), the Medicare Evidence
Contact: — Email: — Development & Coverage Advisory
Committee (MedCAC), the Agency for
Committee includes a biomedical or clinical engineer: — Healthcare Research and Quality (AHRQ),

Name of regulatory agency: U.S. Food and Drug Administration (FDA) Center for —
Devices and Radiological Health (CDRH).
Website(s): http://www.fda.gov/MedicalDevices/default.htm
Contact: Dr. Jeffery Shuren Email: —
Name(s) of other regulatory agency eg. for radiation equipment etc.: United States
Nuclear Regulatory Commission (U.S. NRC); United States Environmental Protection Agency (EPA).
Other agency’s website: https://www.nrc.gov/
https://www.epa.gov/radiation/radiation-regulations-and-laws
372

C3D4 Official nomenclature system for medical devices: Yes Type: Based on GMDN Use: 1. Product Code. FDA- The Center for
Not specified Devices and Radiological Health (CDRH)
uses a nomenclature by assigning
Website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ a 3-letter code to identify a device
ClassifyYourDevice/ucm051637.htm into a generic type or category. This
https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr- nomenclature system is known as product
code classification. The short name is
how-report-medical-device-problems ProCode.The Product Code Classification
Database contains medical device names
and associated information developed
Medical device incorporation by the CDRH in support of its mission.
This database contains device names and
Procurement their associated product codes. The name
Donations —
Website: —
Density per
population


Website: —

Contacts
Name: Ms. Tammie Bell Name: Ms. Mary Lou Valdez
Email: Tammie.Bell2@fda.hhs.gov Email: valdezmar@paho.org
Name: Mr. David E. Hohman Name: —
General comments (...Annex 1): Unfortunately, we are only able to respond to numeric country statistics. As is
often the case, they are too much difficulty for Federal States to answer; furthermore, is largely irrelevant for a system like
ours that is so based on private sector.
Uruguay

6.19 79
High
aged 30-70 yrs from 16.50% >10% (>25%) of — (—)
income (%):i
Human Development
0.82
Years

(0.71): 30.8 (69)
very high
rank:f
High-technology
ICT Development
7.2 (42) exports (% of 8.30%
Index (rank):g

Website: https://www.gub.uy/ministerio-salud-publica/
Ministry of health responsible for health technology policy implementation: Departamento de Evaluación de Tecnología.

Lists available: Yes Las listas aún no se encuentran disponibles
públicamente.
Unit: Departamento de Evaluación de Tecnología.
Website: —
Website: —
e
HTA is performed by the department
HTA unit/department includes the assessment of medical devices: Yes of Health Assessment (MOH), and the
Unit/department: Departamento de Evaluación de Tecnología, MoH. National Resources Fund (FNR) in several
areas concerning health products, and
Website(s): https://www.gub.uy/ministerio-salud-publica/evaluacion-tecnologia healthcare, including medical devices.
http://www.fnr.gub.uy/

Name of regulatory agency: Ministerio de Salud Pública - Departamento de —
Evaluación de Tecnología.
Website(s): https://www.gub.uy/ministerio-salud-publica/evaluacion-tecnologia
Contact: Mr. Juan Manuel Jones Email: tecnologia@msp.gub.uy
Name(s) of other regulatory agency eg. for radiation equipment etc.: Autoridad
Reguladora Nacional en Radioprotección (Ministerio de Industria, Energía y Minería).
Other agency’s website: https://www.gub.uy/ministerio-industria-energia-mineria/institucional/estructura-del-organismo/autoridad-
reguladora-nacional-radioproteccion
374
Uruguay
Website: http://www.msp.gub.uy

Procurement
National level procurement: Yes Website: http://www.cocemi.com.uy/
Donations Adquisiciones: Artículo 6º de la Ley Nº18211
Policy or guideline: Yes Website: https://www.gub.uy/tramites/donaciones-especiales Sistema Nacional Integrado de Salud.
UCA: Un mecanismo para los prestadores
Technical specifications públicos; COCEMI: Un mecanismo para
Technical specifications to support procurement or donations: No algunos prestadores privados.
Website: —
Density per
population

Unit/Department: Departamento de Evaluación de Tecnología. Unit website: —
Contact name: Mr. Juan Manuel Jones Contact email: jjones@msp.gub.uy
Type of inventories available: National functional inventory for medical equipment Realizado en 2008 y actualizado en 2010
para Tomógrafos y Equipos de Resonancia
Website: — Magnética. El detalle de la información
Use of management software: — Software name: — individual aún no se encuentra disponible
en formato electrónico.

Contacts
Name: Dr. Juan Manuel Jones Name: Dr. Hernan J. Montenegro
Email: tecnologia@msp.gub.uy Email: monteneher@paho.org
Name: Mr. Juan Manuel Jones Name: Dr. Wilson Benia
Email: jjones@msp.gub.uy Email: beniaw@paho.org
Uzbekistan

13.95 71
Lower-Middle
aged 30-70 yrs from 25.30% >10% (>25%) of — (—)
income (%):i
Human Development
Years

24.5 (93)
rank:f
High-technology
ICT Development
4.9 (95) exports (% of 0.70%
Index (rank):g

Website: https://www.uzpharm-control.uz/en/
http://ssv.uz/ru
Language(s): —

Unit: —
Website: —
Website: —
e
HTA activities are carried out mainly by the
HTA unit/department includes the assessment of medical devices: No MoH, and the Evidence-Based Medicine
Unit/department: — Centre within the Tashkent Institute for
Advanced Medical Education. HTA is done
Website(s): http://tipme.uz/ for various health topics: pharmaceutics,
Contact: — Email: — medical devices, and also the in
pharmaceutics field but not specifically
Committee includes a biomedical or clinical engineer: — for medical devices, guidelines, etc.

Name of regulatory agency: Ministry of Health, General Directorate for the Quality —
Control of Medicines and Medical Equipment (GDQC).
Website(s): https://ssv.uz/
376
WHO European Region
Uzbekistan
C3D4 Official nomenclature system for medical devices: Yes Type: More than one system —
Use: Not specified
Website: —

Procurement
Donations —
Website: —
Density per
population

Website: https://www.uzpharm-control.uz/en/

Contacts
Name: — Name: Dr. Lianne Kuppens
Email: — Email: kuppensl@who.int
Name: — Name: —
Vanuatu

24.93 52
Lower-Middle
aged 30-70 yrs from 39.70% >10% (>25%) of — (—)
income (%):i
Human Development
Years

— (—)
rank:f
High-technology
ICT Development
2.8 (141) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
National list for specific clinical interventions/emergencies: This list exists as part of another document
Lists available: Yes -e.g. essential drug list or an inventory list
of a health facility- but there is no separate
Website: — nor specific document of the guideline
on its own. No list exists for any of the
conditions above (different diseases/
e
—
Website(s): —

Website(s): —
378
Vanuatu
C3D4 Official nomenclature system for medical devices: Yes Type: Nationally developed When there is a plan to procure a
Use: For procurement purposes medical device, only then is the technical
nomenclature required.
Website: —

Procurement
Donations —
Website: —
Density per
population
Mammograph:α,* 0 0
Radiotherapy:β 0 0

Type of inventories available: National inventory for medical equipment An updated complete list of medical
equipment does not exist at national level;
Website: — but at subnational levels and at facility
Use of management software: No Software name: — level, health managers maintain their
own inventory for various commodities
including medical devices.
Contacts
Name: Dr. Willie Tokon Name: Dr. Eunyoung Ko
Email: wtokon@vanuatu.gov.vu Email: koe@who.int
Name: — Name: —
General comments (...Annex 1): Vanuatu is a small island country in the Pacific region with a population of less
than 350,000: this explains the low level of health facilities available.
Venezuela (Bolivarian Republic of)

24.22 70
—
aged 30-70 yrs from 14.80% >10% (>25%) of — (—)
income (%):i
Human Development
0.71
Years

(0.59): — (—)
high
rank:f
High-technology
ICT Development
5.2 (86) exports (% of —
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
Website: —
e
Las actividades de evaluación de
HTA unit/department includes the assessment of medical devices: Yes tecnologías médicas se han desarrollado
Unit/department: Comisión Nacional de Evaluación de Tecnología en Salud en el marco de la Comisión Nacional
de Evaluación de Tecnología en Salud
(CONETS). (CONETS) dentro del Ministerio del Poder
Website(s): — Popular de la Salud.

Name of regulatory agency: Servicio Autónomo de Contraloría Sanitaria: Dirección —
de Regulación y Control de Materiales, Equipos, Establecimientos y Profesiones de
Salud.
Website(s): —
Contact: — Email: atencion@sacs.gob.ve
Name(s) of other regulatory agency eg. for radiation equipment etc.: Dirección de Regulación y Control de Materiales,
Equipos, Establecimientos y Profesiones de Salud.
Other agency’s website: http://sacs.gob.ve/site/index.php/advanced-stuff/direccion-de-regulacion-y-control-de-materiales-equipos-
establecimientos-y-profesiones-de-salud
380

C3D4 Official nomenclature system for medical devices: No Type: More than one system Does not have one specific nomenclature.
Use: For various purposes For the certification of the medical device,
the nomenclature used is the U.S FDA
Website: https://www.fda.gov/medical-devices/classify-your-medical-device/product-code- product classification.
classification-database

Procurement
Donations Funindes (Univ. Simon Bolivar) is
Policy or guideline: — Website: — authorized by the Autonomous Service
of the Sanitary Comptroller to carry
Technical specifications out equipment analysis for subsequent
Technical specifications to support procurement or donations: — sanitary registration.
Website: —
Density per
population

Website: http://www.sacs.gob.ve/site/

Contacts
Name: — Name: Eco. Cristián Morales
Email: — Email: moralesc@paho.org
Name: — Name: Dr. Joel Caraballo
Email: — Email: carabaljoe@paho.org
General comments (...Annex 1): The most important problems of the hospitals in Venezuela were: the electrical
system, the air conditioning and the vertical system (for 2001). In 2019 the most serious problems were water, sanitation
and hygiene: 79% of hospitals reported failures in the drinking water service; most had the service intermittently, only
two or three days a week. By 2011 there were 1,366 intensive care units. By 2019 there were 36 intensive care beds in
Venezuela. Currently, MRI, CT, and Gamma Camera specialized service is not performed in Venezuelan hospitals. We
Viet Nam

20.94 70
Lower-Middle
9.4%
aged 30-70 yrs from 21.20% >10% (>25%) of
(1.9%)
income (%):i
Human Development
Years

37.1 (42)
rank:f
High-technology
ICT Development
4.4 (108) exports (% of 40.40%
Index (rank):g

Website: —
Language(s): Vietnamese
Ministry of health responsible for health technology policy implementation: Department of Medical Equipment and
Construction.

Unit: —
Website: —
Website - hospitals: https://www.moh.gov.vn/web/ministry-of-health/legal-documents
Website - laboratories: https://dav.gov.vn/procedures.html
Lists available: Yes There are for all general procedures but
they are not complete. We have enacted
Website: — medical device list for procedures which
shall be covered by medical insurance only.
e
The HTA system has been developed by
HTA unit/department includes the assessment of medical devices: Yes establishing nodal agencies within MoH,
Unit/department: Health Strategy and Policy Institute (HSPI). moving towards the Universal Health Care
country goal. Priority-setting mechanisms
Website(s): http://en.hspi.org.vn/vclen/trang-chu and HTA processes are at a nascent stage.
http://en.hspi.org.vn/vclen/Implementation-of-health-technology-assessment-in-Viet- HTA is rarely applied to medical devices.
Nam-t15990-8044.html
Contact: — Email: hspivietnam@hspi.org.vn

Name of regulatory agency: Department of Medical Equipment and Construction. Contact person: Hoang Mai Bui - Director
Website(s): http://www.nimec.gov.vn/ of the Department of medical equipment
verification and calibration.
Contact: Mr. Nguyen Minh Tuan - General director Email: Ngmtuan_ttbvn@yahoo.com
Name(s) of other regulatory agency eg. for radiation equipment etc.: Institute of
Medical Equipment and Construction.
Other agency’s website: https://www.most.gov.vn/en/pages/OrganDetail.aspx?tochucID=2710
382
Viet Nam
Website: —

Procurement
National level procurement: Yes Website: http://www.moh.gov.vn/
Donations —
Website: —
Density per
population

Unit/Department: Department of Medical Equipment and Construction. Unit website: —
Contact name: Mr. Nguyen Minh Tuan - General director Contact email: —
Website: —

Contacts
Name: — Name: Dr. Kidong Park
Email: — Email: parkk@who.int
Name: Mr. Nguyen Minh Tuan - General director Name: Dr. Socorro Escalante
Email: — Email: escalantes@wpro.who.int
Yemen

59.58 44
Low
15.8%
aged 30-70 yrs from 27.60% >10% (>25%) of
(4.2%)
income (%):i
Human Development
0.47
Years

(0.32): 13.6 (131)
low
rank:f
High-technology
ICT Development
Index (rank):g

Website: —
Language(s): —

Unit: —
Website: —
National list for specific clinical interventions/emergencies: There is a need of financial, technical
Lists available: No support and cooperation to put national
Website: — standards or lists of recommended
medical devices for specific procedures.
For different diseases/situations there are
e
National health technology assessment unit no existing lists; MOPH must do that by
—
Website(s): —

Name of regulatory agency: Ministry of Industry & The Supreme board for Drugs & There are Authorities only for the
Medical Appliance. registration of agents for medical
Website(s): www.sbd-ye.org; www.moit.gov.ye equipment.
Contact: Dr. Alhakmi Email: —

industry & The Supreme board for Drugs & Medical Appliance.
Other agency’s website: www.moit.gov.ye
https://gnssn.iaea.org/main/ANNuR/Activity%20Documents%20%20Public/Training%20Course%20on%20knowledge%20safety%20
networks/Knowledge%20safety%20Network-Yemen%20.pdf
384
Yemen
Website: —

Procurement
Policy or guideline: Yes Website: www.htb.gov.ye
Donations There are many procurements carried
Policy or guideline: Yes Website: http://moh.gov.ye/en/home.aspx out at a national level but non-uniform
standards by the health Governorate
Technical specifications Office, local governorates authority,
Technical specifications to support procurement or donations: Yes general hospitals authority, police health
service, and army health service; and there
Publically available: No are procurements carried out at a national
level like Unicef, UNFPA, Emro, etc.
Website: —
Density per
population

Unit/Department: The General Directorate of Medical Equipment and Maintenance. Unit website: —
Contact name: Mr. Faisal Ali Mujamal Contact email: eng- alfaisal@hotmail.com
Type of inventories available: None The MOPH is working in its action plan
state to complete the database for medical
Website: — equipment. In the case of some hospitals,
Use of management software: No Software name: — the inventory is done directly by them.

Contacts
Name: Mr. Faisal Ali Mujamal Name: Dr. Adham Rashad Ismail Abdel Moneim
Email: eng- alfaisal@hotmail.com Email: ismaila@who.int
Name: — Name: —
General comments (...Annex 1): There was a deficiency about maintenance and calibrations of medical devices.
Zambia

61.38 55
Low
0.3%
aged 30-70 yrs from 24.60% >10% (>25%) of
(0.0%)
income (%):i
Human Development
Years

19.4 (122)
rank:f
High-technology
ICT Development
2.5 (146) exports (% of 2.30%
Index (rank):g

Website: —
Language(s): —
Ministry of health responsible for health technology policy implementation: Medical Equipment Unit.

Lists available: Yes, but it is only a recommendation The MoH has developed the Standard
Equipment Lists (SEL) for District facilities
Unit: Minsitry of Health, Directorate of Clinical Care and Diagnostic Services-Medical such as Health Posts, Health Centres and
Equipment Unit. Level One Hospitals). The SEL are not
yet done, because the Basic Health Care
Website: — Package, which is the blueprint for health
Website: —
e
Evidence-informed healthcare priority
HTA unit/department includes the assessment of medical devices: No setting via HTA is at early stages. Currently,
Unit/department: — HTA is being used by the MoH to build the
Health Benefits Package.
Website(s): —

Name of regulatory agency: Ministry of Health-Directorate of Clinical Care and —
Daignostic services-Medical Equipment Unit.
Website(s): http://www.moh.gov.zm
Contact: Dr. Zuma Munkombwe Email: zmunkombwe@pra.gov.zm
Name(s) of other regulatory agency eg. for radiation equipment etc.: Zambia
Medicines Regulatory Authority (ZAMRA).
Other agency’s website: http://www.zamra.co.zm/
386
WHO African Region
Zambia
For regulatory and procurement purposes
Website: —

Procurement
Policy or guideline: Yes Website: https://www.moh.gov.zm/docs/reports/Medical%20
Equipment%20Management%20Guidelines.pdf Medical device incorporation
National level procurement: Yes Website: http://www.parliament.gov.zm/sites/default/
This is in reference to the guidelines on
files/documents/acts/The%20Zambia%20Medicines%20and%20Medical%20Supplies%20 procurement, donations, replacement
Agency.%20Act%20No.%209.pdf of equipment at end of the lifespan. The
Ministry of Health procures, under Mandate
Donations from ZPPA; the Ministry of Health develops
Policy or guideline: Yes Website: — the list, quantities and specifications. Public
Procurement Authority sets the framework
Technical specifications for the procurement mostly International
Technical specifications to support procurement or donations: Yes Competetive Bidding. These are provided
Website: —
Density per
population

Unit/Department: Medical Equipment Unit. Unit website: —
Type of inventories available: National inventory for medical equipment The national data bank for equipment is
in its infancy; the data was collected three
Website: — years ago during a project that was funded
Use of management software: Yes Software name: ECRI and other nationally by the Japan International Cooperation
Agency (JICA). Currently, this data will
developed. be upgraded this year. The information
captured includes Equipment Description,
Model, Maker, Serial Number, Location,
Medical devices workforce Functional Status, Age of Equipment.
There are however hard copies at the
Number of biomedical/clinical engineers professionals in the country:γ 18 facility level which maintenance units
Contacts
Name: Mr. Fales Mwamba Name: Dr. Nathan Nsubuga Bakyaita
Email: Mwamba@moh.gov.zm Email: bakyaitan@who.int
Name: Mr. Chipalo Kaliki Name: —
Email: ckaliki@moh.gov.zm Email: —
General comments (...Annex 1): The WHO used

to run training programs for maintenance technicians but stopped long ago, this has affected this field. There is a need
for the WHO to come in strongly in support of maintenance of Medical equipment. The main problems in developing
countries are lack of skilled manpower, inadequate budgets for maintenance, lack of proper maintenance facilities
equipped with tools, test and calibration equipment, lack of supportive policies. Coupled with a lack of local agents for the
Zimbabwe

53.89 55
Lower-Middle
aged 30-70 yrs from 28.40% >10% (>25%) of — (—)
income (%):i
Human Development
0.57
Years

(0.44): 20 (120)
medium
rank:f
High-technology
ICT Development
2.9 (136) exports (% of 5.00%
Index (rank):g

Website: —
Language(s): —

Unit: Hospital Equipment Unit.
Website: —
Website: —
e
It has been started the building capacity
HTA unit/department includes the assessment of medical devices: No and the HTA will be a fundamental tool to
Unit/department: — achieve the Universal Health Care goal.
Website(s): —
Contact: Mr. Martin Nhorivo Email: mnhorivo@yahoo.co.uk

Website(s): —
388
WHO African Region
Zimbabwe
Website: —

Procurement
Donations —
Website: —
Density per
population

Unit/Department: Hospital Equipment Unit. Unit website: —
Contact name: Mr. Martin Nhorivo Contact email: mnhorivo@yahoo.co.uk
Website: —

Contacts
Name: Dr. Christopher Tapfumaneyi Name: Dr. Alex Gasasira
Email: tapfuman@gmail.com Email: gasasiraa@who.int
Name: Mr. Martin Nhorivo Name: Dr. Stanley M. Midzi
Email: mnhorivo@yahoo.co.uk Email: midzis@who.int
General comments (...Annex 1): The country health technology policy document was initiated in 2007 with
funding from the US. This is currently being formulated into a policy document for diagnostic imaging and medical
devices.
A1B2
C3D4
A1B2
C3D4
Annex 1
Additional comments
A1B2
C3D4
A1B2
C3D4
A1B2
C3D4
Global atlas of medical devices 2022 e
National list of approved priority/ National list for different

Country WHO essential medical devices, types of healthcare facilities National list for specific clinical National health technology
region (including IVDs), for procurement (hospitals, laboratories, etc) interventions/ emergencies assessment unit
or reimbursement
Afghanistan EMR — — — The National HTA unit is not yet
established.
Albania EUR — — — There is not yet an HTA national

unit but it has been acknowledged
at a political level by the MoH.
There is a centralized system for
managing health products pricing
and reimbursement via the Ministry
of Health, the National Agency for
Drugs and Device, and the Drug Price
Commission.
Algeria AFR — — — Adopted EMA (European Medicines

Agency) and ICH (International
Council for Harmonisation for
Pharmaceuticals) guidelines.
Inspector General Office performs
health economics HTA. Within
the MoH HTA is focused on
pharmaceutics but not in medical
devices.
Andorra EUR — — — There are identified HTA activities but
not a national unit.
Angola AFR — — — —
A2
C3D4
A1
A1B2
C3D4
C3
A1B2
C3D4
Annex 1. Additional comments

Medical Device incorporation: Inventories and medical
Country National regulatory Medical device nomenclature procurement/donations/ equipment management General Comments
authority system technical software comments:
specifications:
Afghanistan — — — — Concerning the HT national
policy, it can be found the
following document, within
the provided website: ley-
18211-dec-5-2007 SNIS.pdf.
Albania — This italian nomenclature system It exists the National Policy The inventory system is Concerning the HT national
CIVAB comes with the Inventory for management of medical called CLINGO. The National policy, it was provided the
system called CLINGO. devices in Albania. The Biomedical Centre manages following document:|http://
procurement of medical the system. Each hospital www.who.int/medical_
devices at national levels is (13 regional hospitals are devices/survey_resources/
done partially. involved) is in charge of health_technology_national_
adding their own data. It policy_albania.pdf
doesn't cover all the hospitals
and other public health
institutions.
Algeria — — — — —
Andorra — — — — —
Angola June 4, 2021: With — — — —

Presidential Decree
136/21 the extinction of
the Direcção Nacional
de Medicamentos
e Equipamentos is
announced and the
Regulatory Agency for
Medicines and Health
Technologies (ARMED)
is created, which will
have its headquarters in
Luanda, Angola and will be
supervised by the Ministry
of Health.
A3

or reimbursement
Antigua and AMR — — — —
Barbuda
Argentina AMR Existe una base de datos que Cirugía, diagnóstico por Actualmente existen lineamientos In 2018, by Ministerial Resolution
contiene a las tecnologías sanitarias imágenes, laboratorio, terapia para la elaboración de guías. of Health No. 623, the National
(denominados productos médicos) intensiva. Disponible en la segunda página Commission for the Evaluation of
registradas y disponibles en el sitio web proporcionada. Health Technologies (CONETEC)
-ver tercera liga web- (accesible was created within the scope of the
con colocar nombre génerico de Ministry of Health, dependent on its
producto (por ej: apósito) o con su General Coordination Unit.
identificación (Nº de PM). Other national agencies that prepare
HTA reports:
National Directorate for Quality and
Regulation, Ministry of Health of the
Nation https://www.argentina.gob.ar/
salud/calidadatencionmedica
National Administration of Medicines,
Food and Medical Technology –
ANMAT
https://www.argentina.gob.ar/anmat
• HTA programs at the subnational
level:
Argentina has several subnational
Ministries of Health that have STD
Directorates or Committees that
carry out HTA reports: City of Buenos
Aires and the Provinces of Buenos
Aires, Neuquén, Santa Fe, Río Negro
and Mendoza.
• Other agencies that prepare HTA
reports in the country:
- Argentine Network for Health
Technology Assessment (RedArETS)
whose member nodes are: Ministry
of Health of the City of Buenos Aires,
Ministry of Health of the Province of
Buenos Aires, Ministry of Health of
the Province of Mendoza, Ministry of
Health of the Province of Neuquén,
Ministry of Health of the Province of
Río Negro,
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specifications:
Antigua and — — — — —
Barbuda
Argentina — The Administración Nacional For procurement of medical — The MoH wants to push
de Medicamentos Alimentos y devices at national level we use awareness/surveillance
Tecnología Médica (ANMAT), the: "lista licitaciones". about health technology
reported the use of the Universal quality, technical
Medical Device Nomenclature specifications, etc.
System (UMDNS) for regulatory
purposes of the medical devices
in this country
A5

or reimbursement
Argentina Ministry of Health of the Province
continued of Santa Fe, Superintendence of
Health Services, El Cruce Hospital,
Higher School of Health - FBCB /
Universidad Nacional del Litoral,
Universidad Nacional del Sur,
University Center for Studies in
Health, Economy and Welfare of
the National University of Comahue,
University Center of Pharmacology
of the National University of La Plata,
Heart Institute of Corrientes, National
Cancer Institute, National Directorate
for Quality in Health Services and
Regulation Sanitary of the Ministry of
Health of the Nation.
- Institute of Clinical and Health
Effectiveness (IECS)
- University Center of Pharmacology
of the National University of La Plata
(CUFAR – UNLP)
- Institute of Medicine for Social
Security and Technological Evaluation
(IMSSET – UBA).
- ISALUD University (ISALUD)
- A recent study surveyed and
identified 39 institutions that carry
out some type of HTA report in
Argentina.
Armenia EUR — — — Informing decisions of the cited
institutions are not specifically HTA.
Alternative email: info@healthpiu.arm.
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specifications:
Argentina
continued
Armenia "National Institute of — The technical specifications — —

Metrology”; National are developed by the Health
Institute of Standards”; Project Implementation Unit
"ArmAtomInspection"; and (HPIU) biomedical engineer in
"Scientific Center of Drug cooperation with international
and Medical Technology consultants.
Expertise".
A7

or reimbursement
Australia WPR Australian Register of Therapeutic — — The Therapeutic Goods
Goods (ARTG) – marketing approval Administration (TGA), the Medical
and used to guide procurement Services Advisory Committee
in national and state/territory (MSAC), the Pharmaceutical
processes Advisory Committee (PBAC), and the
•Prostheses List of implanted Prostheses List Advisory Committee
medical devices for private patients (PLAC) perform Health Technology
- reimbursement Assessment (HTA) processes to
•National hearing program provide advice to the Australian
aids, devices and appliances – Government Department of Health.
reimbursement
•National diabetes service scheme
– subsidisation diabetes devices
including continuous glucose
monitoring devices
•National stoma appliance scheme
•Veterans rehabilitation and
appliance schedule of devices and
reimbursement
•National Disability Insurance
Scheme list of devices and
appliances
Austria EUR — — Österreichischer Strukturplan Only for the hospital benefit
Gesundheit (up mentioned link) and catalogue there is a national HTA
various guidelines of the medical process in place, but not for drugs. It
societies, internal guidelines of the is expected that it will be a process in
hospitals, etc. Also, there is the place in the next 1-2 years.
Austrian Influenza Pandemic Plan.
Azerbaijan EUR — — — The HTA activities in pharmaceutics

are not specifically for medical
devices.
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specifications:
Australia — The use of GMDN is a legal — The National Product Australia’s health system
mandatory requirement for Catalogue provides an policy and delivery is at both
devices supplied in Australia, inventory input to a number a national and state/territory
including IVDs. of hospital procurement and level
equipment managements All medical devices must be
systems. Also, various systems included in the Australian
are used by public and private Register of Therapeutic
hospitals Goods
Austria — As per regulation 2017/45 on The procurement is done There are various software —
medical devices and Regulation with internal guidelines of the for the maintenance and
(EU) 2017/746, the EU Member Hauptverband, insurance funds, inspection of medical devices
States Competent Authorities of hospitals, Bundesbeschaffungs in the hospital. Additionally,
MD representatives (of both the GmbH, etc. there is the implementation
national MoH and the national of a National Plan for high-
agencies) of the MDCG, have cost technologies called:
opted for the publicly available, "Großgeräteplan".
accessible and transparent
nomenclature named European
Medical Device Nomenclature
(EMDN)
Azerbaijan — — The Procurement guidelines — —
are under development. For
donations guidelines the
WHO are the ones used.
The corresponding technical
specifications are under the
responsibility of the Innovation
and Supply Centre.
A9

or reimbursement
Bahamas AMR — — There are no lists recommending —
health technology for any of the
above.
Bahrain EMR — — — There are identified HTA activities but

Bangladesh SEAR — — — ▬
Barbados AMR — — — HTA activities have been identified,

but there is not a national unit.
Belarus EUR Documents: N° "2007 ” and N° — — In BELCMT there are not informing
"458" in the specified website. decisions specifically for medical
devices.
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specifications:
Bahamas — — The Public Hospitals Authority, — —
the corporate entity of
the Ministry of Health, is
responsible for managing the
three Public Hospitals within
the Bahamas. It uses the
services of the ECRI Institute
to assist in the procurement of
medical devices.
Bahrain — It is needed the GMDN code for — — —
registration of medical devices,
as well as the HS code.
Bangladesh Ms. S. M. Sabrina Yesmin — Technical specifications are not Central Medical Stores Depot, —
is the Assistant Director of publically available. Tejgaon, Dhaka-1208. Dhaka
DGDA. has all the data in this regards.
Barbados — — Procurement queries, There is not a national Concerning the Healthcare
comments, and information inventory but the Queen Infrastructure section: there
should be addresses to the Elizabeth Hospital Engineering are many single and grouped
Chief Supply Officer (email: Services maintains an medical centres|and general
joness@gob.bb). inventory of high-cost practice clinics/offices which
technologies and medical perform primary care that
equipment; thus, there is an includes emergency services.
institutional inventory there. Some medical centres of
Also, all the polyclinics keep the private sector perform
institutional inventory for secondary care services as
medical equipment only. The well.
institutional inventories at the
hospital and the polyclinics are
audited annually. Additionally,
the Equipment management
software is currently being
installed at the Queen
Elizabeth Hospital.
Belarus — State register of medical Public procurement of medical Go to website (first link) and —
equipment and medical supplies devices and their specifications find the document titled
of Belarus. for each procurement "mfindr".
procedure can be found in our
website.
A11

or reimbursement
Belgium EUR Ces listes existent indirectement — Ces listes existent indirectement The assestment includes pre-market
par le remboursement de certains par le remboursement de certains clinical evaluation of innovative high-
dispositifs médicaux et/ou le dispositifs médicaux et/ou le risk medical devices.
remboursement de certains tests remboursement de certains tests
cliniques effectués. Les dispositifs cliniques effectués.
médicaux implantables et invasifs
à long terme doivent se trouver
dans ce listing de l'INAMI pour
pouvoir être facturés par l'hôpital
aux patients.La liste est disponible
sur internet via le lien signalé.
Approvement for reimbursement by
type of IVD device or analysis, not a
product-specific list.
Belize AMR — Policy Analysis & Planning Unit, There is no information about which HTA activities have been identified,
Ministry of Health. lists are available. but there is not a specific national
unit.
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specifications:
Belgium Agence Fédérale de As per regulation 2017/45 on Dans chaque Arrêté royal — L’Agence fédérale de
Contrôle Nucléaire en ce medical devices and Regulation d'application se trouvent des Contrôle nucléaire (AFCN)
qui concerne les dispositifs (EU) 2017/746, the EU Member exigences par rapport à la est en train de réviser les
médicaux repris sous States Competent Authorities of distribution et/ou la délivrance inventaires des dispositifs
le point 3 de l'annexe MD representatives (of both the des dispositifs médicaux (docs: médicaux émettant des
XIII de l'Arrêté royal du national MoH and the national coord_tcm291-26685.pdf and rayonnements ionisants
18/03/1999, qui veille au agencies) of the MDCG, have tcm291-27069.pdf).|Décision présents en Belgique. Cet
contrôle et à l'application opted for the publicly available, de la Commission 2002/364/ inventiare provient en partie
du Règlement Général de la accessible and transparent EC portant spécifications de données fournies par
Protection de la population, nomenclature named European techniques communes des les Organismes Agréés (AV
des travailleurs et de Medical Device Nomenclature dispositifs médicaux de Controlatom, TechniTest,
l'environnement contre le (EMDN) diagnostique in vitro. ….). COCIR (European
danger des Rayonnements Coordination Committee
Ionisants (le RGPRI: AR of the Radiological,
du 20 juillet 2001), dans Electromedical and
lequel sont stipulées des Medical IT Industries)
conditions /exigences en ce peut également fournir
qui concerne les dispositifs des informations utiles sur
médicaux relevant de les dispositifs d’imagerie
sa compétence3. SPF diagnostique médicale
Economie, P.M.E, Classes en incluant l’âge de
Moyennes et Energie: l’équipement (age profile).
Les Directions Générales Rappelons que l’OECD a
Energie, Qualité & Sécurité aussi mené une enquête
et Contrôle & Médiation avec des questions
sont compétents pour le similaires, organisation à
contrôle des dispositifs laquelle les données ont été
médicaux tombant mentionnées par l'AFCN.
dans la catégorie 2 de
l'annexe XIII de l'AR du
18/03/1999 relatif aux
dispositifs médicaux. Anne.
VanNerom@iph.fgov.be, T
++32 (0) 2 642 50 40 2.
Belize — — The NEMC is trying to The NEMC is in the process of —
standardize equipment, and updating the Inventory, only
has suggested to set up a for the public health facilities.
procurement committee. There The Karl Heusner Memorial
is no follow up. Hospital (KHMH) has its own
Inventory System.
A13

or reimbursement
Benin AFR — — — Ilya la Direction de la programmation
et de la prospective (DPP) et
Direction des hôpitaux (fait HTA),
mais n'est pas specifiquement pour
des dispositifs médicaux.
Bhutan SEAR We have a list for each level of — At present we do not have national HTA is focused on pharmaceutics and
health centre used for annual lists of recommended medical vaccines but not in medical devices.
identification for non drug items devices but we are developing a
which includes equipments but we standard list of Equipment and
have not uploaded it in a website. non-drug items for each level of
health facilities in Bhutan (national,
regional, district hospital, Basic
health unit I and Basic health unit II).
The standard list of equipment will
be based on the standard services
that will be provided at each level of
the health centre. The standard list
is available since 2012.
Bolivia AMR There is a national medical devices Norma de caracterización de Ver el Manual para la aplicacion —
(Plurination- list (LINADIME) and it is not establecimientos de salud de de las prestaciones de seguros
al State of) based in any of the internationally primer nivel, La Paz, Bolivia, públicos de salud, La Paz, Bolivia.
recognized nomenclature. 2008.
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specifications:
Benin — La nomenclature CNEH: Centre — — —
National d'Expertise Hospitalière
Nomenclature (from France) est
utilisée de façon informelle dans
certains de nos hôpitaux.
Bhutan The Medical Devices Adapted nomenclature from The procurement of MD is The Biomedical Engineering Concerning the
regulation is currently GMDN conducted by the Medical Division under the Department Infrastructure section: there
being drafted Supplies Procurement Division. of Medical Services has is 1 National Referral Hospital
maintained an Inventory of with 350 beds, 2 Regional
equipment above 25,000 referral hospitals with
rupees only. 150 beds each, 10 district
hospitals with 60 to 40 beds.
12 district hospitals with
20 beds. Out of 192 health
posts, 18 are Basic Health
Unit grade I with 10 beds,
and the remaining 174 health
centres with 2 to 5 beds are
Basic Health Unit grade II.
Bolivia Unidad de Seguros — Se cuenta con la propuesta El inventario de equipos y —
(Plurination- Públicos de Salud - Dante de la norma "Pliego de la aplicación del plan para
al State of) Ergueta tel. 591-22495053; especificaciones técnicas para la adquisición de equipo
Unidad de Servicios de la adquisición de dispositivos médico solo se realizó para los
Salud - Javier Luna Orozco médicos" DBC. La adquisicion departamentos de Oruro, Beni
tel. 591- 22495053. se realiza a través de los y Pando.
gobiernos municipales (Ley del
Medicamento 1737, Reglamento
a la ley del Medicamento
25235).
A15

or reimbursement
Bosnia and EUR There are the lists of medical The Rulebook on Normative There are documents that regulate The HTA is acknowledged in
Herzegovina devices for procurement regarding Standards for Establishment of the necessary knowledge, skills, decentralized legislation, and present
the each general hospital as well as Health Institutions. procedures and equipment at a national level.
clinical centres (situation analysis (definition of medical technology)
of health care institutions). At the which are used by those group of
primary health care level, there is a diseases. Also, there are Guides for
list of medical equipments that is specific medical conditions, and
necessary for family medicine. there are adequate contingency
plans for responding for public
health threats as needed. The
Rulebook on National Standards for
Establishment of Health Institutions,
Standards for Primary Care and
Hospitals.
Botswana AFR — Documents are in constant — It is needed to strengthen the
revision and update. research to improve the HTA
capacity.
Brazil AMR Lists for diseases are Health — Competencia de la Health Attention HTA for medical devices, medicines,
Attention Secretariat (SAS) unit Secretariat (SAS). interventions, etc. There exist several
competence. Other lists are not agencies (see third link).
available for the moment.
Brunei WPR — — — It is a established system for setting

Darussalam healthcare priorities, which involves
HTA.
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specifications:
Bosnia and For the Republika Srpska: The nomenclature is based Responsible authority in both — —
Herzegovina Regarding the procurement on GMDN and EDMA codes; entities. Ministry of Health of
of various medical devices, the instructions request Republika Srpska is responsible
the company that generally manufacturer and representative for the procurement of high-
provides the medical of manufactures to use GMDN or cost technologies while the
device must ensure EDMA codes for making generic Health Care Institutions can
capable suppliers who names. This country have free provide procurement of other
can implement a proper access to the GMDN base, and medical equipment.
assessment and who can found a new version of EDMA
carry out the certification codes on the internet.
of medical devices.
Botswana There is a drug regulatory — — There is the Medical Concerning the

unit. It has a draft for Equipment Asset Register Infrastructure section: there
an Act that will regulate which was completed are 800 clinics, healthposts
medicines and medical in December 2009. The and mobile clinics.
devices. Custom Solution is being
implemented; the contract
was signed on May 19th 2010.
Brazil — Anvisa started working to In the given website search for Even though there is no —
internalize the GMDN. So far, 100 the corresponding documents standardized software for
of Anvisa's technical names are in procurement field. There are the medical equipment
compatible with GMDN. Anvisa Lists of OPM, Procedures and management in Brazil, some
also works in the implementation Protocols. hospitals and other health
of the Unique Device facilities have developed
Identification (UDI) in Brazil. and implemented their own.
Anvisa is currently preparing Besides that, the Post Market
a draft proposal in a working Surveillance of Medical
group with the participation of Devices Unit of ANVISA, the
the private sector, which was Brazilian Regulatory Authority,
sent to the Public Consultation intends to develop a software
(2021). to address the main needs
related to medical electrical
equipment management
(information related to
the history of the medical
equipment).
Brunei — — — — —
Darussalam
A17

or reimbursement
Bulgaria EUR — — — It exists a limited number of trained
HTA experts. Relevant health
economic education is available at
several universities in the region, and
HTA experts or health economists
work as consultants for the
government (more info see third link).
Burkina Faso AFR — — — —
Burundi AFR Nous avons des listes préétablies Nous avons également de Lists available for communicable —
suivant le type de catégories la documentation sur la and non communicable diseases,
conformes aux normes en vigueur normalisation des équipements injuries, and public health |
au MoH. par structures de soins. emergency situations.
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specifications:
Bulgaria — As per regulation 2017/45 on Only for the devices which are — —
medical devices and Regulation supplied through a centralized
(EU) 2017/746, the EU Member procedure accomplished by the
States Competent Authorities of Ministry of Health.
MD representatives (of both the
national MoH and the national
agencies) of the MDCG, have
opted for the publicly available,
(EMDN)
Burkina Faso The RPNS within the — Les achats se font selon Inventaire technique au niveau Concerning the HT national
NRA is in the process of plusieurs procédures en national a été fait par la policy, a 2010 version was
institutionalization. fonction de la source de DGIEM en 2003 avec l'appui provided. Concerning the
financement (les projets font de la GTZ; un inventaire non Section Infrastructure: There
des appels d'offres de façon technique a été fait par la are 3 CHU and 1 Hôpital
indépendante, les hôpitaux DAF en 2007 suivant une national.
exécutent en interne une partie procédure du Ministère de
du budget achat, les achats l'Economie et des Finances. La
groupés au niveau national sont mise à jour de ces inventaires
en train d'être expérimentés par n'est pas effective. Il y a
la CAMEG: Centrale d'Achat des les deux types d'inventaire:
Médicaments Génériques); des national fonctionnel pour
apels d'offres internationaux certain équipement médicale
sont quelque fois lancés par les et non-fonctionnel pour
projets. d'autres.
Burundi — — Procédé aux achats/Système — —
d'appel d'offres ouvert
national/international.|Il existe
des entreprises nationales
spécialisées dans la vente de
ces produits.
A19

or reimbursement
Cambodia WPR — a) Medical Equipment Standard — It has been started the development
list for CPA referral Hospitals; |b) of HTA systems by establishing nodal
Medical Equipment Standard list agencies and conducting ad-hoc
for Minimum Package of activity activities.
(MPA) (Health Centre).
Cameroon AFR — — — —
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specifications:
Cambodia — The Hospital Service Bureau has Procurement: Health Sector The software was originally —
developed standard medical Support Program (HSSP2) is developed by the Ministry
equipment nomenclature for the implementation project of Health (MoH). The
public hospitals in Cambodia and team under the direction of Department of Hospital
it has been utilized for medical Health Sector Strategic Plan service is managing
equipment management and (HSP2) of the Ministry of inventories for medical
maintenance. Health.|Medical Equipment equipment of four National
standard list for CPA1,2,3 hospitals and 18 CPA3 level
referral hospitals. hospitals. The Controlled
medical equipment requires
management (monitoring),
maintenance and repair.
Cameroon Il existe un organisme — Procurement: Il existe des Les bailleurs de fonds réalisent L'étude devrait inclure la
chargé de la directives générales concernant des inventaires dans leurs formation dans le domaine.
réglementation concernant tous les marchés publics. Les zones d'intervention, mais Le Cameroun dispose d'un
les équipements hôpitaux et autres formations il n'existe pas d'inventaire cycle de formation de
qui émettent les disposent aussi de budgets national. techniciens en maintenance
rayonnements ionisants. propores pour l'achat de hospitalière qui fonctionne
l'Agence Nationale de dispositifs médicaux. depuis deux ans dans trois
Radioprotection. Contact: lycées techniques, le diplôme
Dr. SimoAugustin, e-mail: de sortie délivré au bout
augsimo@yahoo.fr. |We de trois ans est l'équivalent
added a website link that du bacccalauréat. Il existe
directs the user to an NRPA également des cycles de
presentation. formation dans le domaine
en enseignement supérieur.
A21

or reimbursement
Canada AMR Given the nature of the Canadian — Given the nature of the Canadian There are several HTA agencies,
Constitution, these are of provincial Constitution, these are of provincial mainly regional.
jurisdiction and not at the federal or jurisdiction and not at the federal or
national jurisdictional level. national jurisdictional level.
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specifications:
Canada In addition, for radiation Canada uses both: Preferred Given the nature of the Given the nature of the In several survey’s sections
emitting medical devices, Name Codes (based on US FDA Canadian Constitution, these Canadian Constitution, these (e.g. section health policy),
there is Health Canada, Panel Codes) and GMDN. Not are of provincial jurisdiction and are of provincial jurisdiction we were not able to reflect
Healthy Environments and publicly available. not at the federal or national and not at the federal or the shared governance
Consumer Safety Branch, jurisdictional level. national jurisdictional level. approach that Canada has
Consumer and Clinical While there are no national evolved towards as several
Radiation Protection inventories, the Canadian as the key organisations,
Bureau (http://www.hc-sc. Institute for Health Information namely, the Canadian
gc.ca/ahc-asc/branch- produces regular reports on Agency for Drugs and
dirgen/hecs-dgsesc/psp- selected imaging technologies Technologies in Health
psp/ccrpb-bpcrpcc-eng. in Canada. The most recent are neither national nor
php). Contact Person: report is available at:|https:// provincial but entities whose
Narine Martel, Director, www.cihi.ca/en . governance and financing
Consumer and Clinical is shared among the
Radiation Protection Deputy Minister of Health of
Bureau. Canada's 14 jurisdictions (e.g.
Federal, 10 provinces and
3 Territories). In addition,
the survey did not allow
for the identification of
existing provincial capacities
which would have resulted
in having to fill 13 separate
surveys to accurately reflect
Canada's reality. Concerning
HT national policy, it was
provided the following
document:|http://www.
who.int/medical_devices/
survey_resources/health_
technology_national_policy_
canada.pdf .
A23

or reimbursement
Cabo Verde AFR Standards: CARTA SANITÁRIA DE Standards: CARTA SANITÁRIA No, it is done according to the HTA is focused on pharmaceutics but
CABO VERDE (1999). DE CABO VERDE (1999). needs and the procedures of our not in medical devices.
action plan for the next years.
Central AFR En concernant acquisition il ya une — Arrêté du ministre de la santé —

African longue durée entre la commande et publique et de la population.
Republic la réception. Profil des participants: Médecin,
chirurgiens, techniciens de santé,
techniciens bio médicaux. Date de
révision: Mars 2010.
Chad AFR It is needed to revise the list — — —
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specifications:
Cabo Verde There is a department in — — There is no national inventory In conclusion, there is
charge of medical devices, of medical equipment. There's a need to organize the
but there is no legislation a plan to do it soon. park of medical devices.
nor registration of medical We would like to make
devices yet. a national inventory for
medical equipment, assess
the needs, and organizing
technical guidelines for
procurement to elaborate a
clear plan of medical devices
management. We think it is
time to develop legislation
Central No. — Achat groupé par les Réalisée par la direction des Concerning the HT national
African parténaires, passation de infrastructures sanitaires. Il y policy it is stated in the
Republic marché. Longue durée entre la a les deux types d'inventaire: following document
commande et la réception. national fonctionnel pour POLITINACIONALSAUDE_
certain équipement médicale VERSÃOVALIDADA 2020.
et non- fonctionnel pour
d'autres.
Chad — — There is a need to update the — The lack of a national
guideline. policy in matters of health
technology does not allow
access to information on
medical devices that could
support the action plan with
regards to training of users,
specialists and maintenance
technicians.
A25

or reimbursement
Chile AMR Existen 8 listas de los dispositivos — No se dispone de las listas de —
médicos que están bajo control tecnologías sanitarias de este
obligatorio en el país: Guantes apartado.
de examinación, Guantes
quirúrgicos, Preservativos
masculinos y femeninos de látex
y sintéticos, Agujas hipodérmicas,
Jeringas hipodérmicas de un
solo uso, Jeringas con agujas
hipodérmicas y Desfibriladores
Externos Automáticos Portátiles.
Se encuentran disponibles en la
dirección proporcionada:|https://
www.ispch.cl/andid/listado-
de-dispositivos-medicos-
establecimientos-y-empresas/
dispositivos-medicos-con-registro-
sanitario/
China WPR — — — —
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specifications:
Chile — — http://www.minsal.cl — Concerning the
Infrastructure section: Los
21 centros de salud están
incorporados en los 100
hospitales distritales/rurales.
Los Centros de Referencia
de Salud (CRS) = 7 considera
a los Hospitales de Chile
denominados de Mediana
Complejidad y que se ubican
en la región metropolitana
y demás regiones del país.
|Tambien existen también
los hospitales de Chile
denominados de Alta
Complejidad. Se ubican en
la región metropolitana y
demás regiones del país.
Estos hospitales tienen la
calidad de “Establecimientos
Auto-gestionados en red”,
incluyendo los base de
regiones y los Institutos
de especialidades, que
se concentran en la
Región Metropolitana.
|En lo que concierne a
los Centros de Salud de
atención ambulatoria de
especialidades. Son 5 de la
Región Metropolitana y dos
ubicados en regiones del
norte y sur del país.
China — — — — —
A27

or reimbursement
Colombia AMR No existe un listado oficial. — — The INVIMA (Instituto Nacional
El acuerdo No.008 de La de Vigilancia en Medicamentos y
Comisión de Regulación en alimentos) and the IETS (Instituto
Salud (CRES) establece que los de Evaluación Tecnológica en Salud)
dispositivos médicos usados en perform HTA.
los procedimientos listados son
reembolsados dentro del Plan de
Beneficios en Salud.
Comoros AFR — — — —
Congo AFR — — — —
Cook Islands WPR — — — There are identified HTA activities but

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specifications:
Colombia El INVIMA tiene dos Nationally developed. It is in the — Actualmente no hay inventario Actualmente se tiene
dependencias relacionadas, phase of implementation. nacional, se ha intentado reglamentado y en fase de
la Subdirección de elaborar mediante el catastro implementación el Programa
Registros Sanitarios que de equipamiento físico. En Nacional de Tecnovigilancia
tiene un grupo funcional la normatividad vigente, Post-mercado liderado por
específico de dispositivos el Decreto 4725 de 2005, el Instituto Nacional de
médicos y se encarga de la establece que los equipos Vigilancia de Medicamentos
evaluación y autorización biomédicos de tecnología y Alimentos (INVIMA)
pre-mercado de los controlada deben contar (importantes para la
dispositivos médicos; y la con registro sanitario o con gestión y manejo de los
Subdirección de Insumos permiso de comercialización dispositivos médicos),
para la Salud que se en Colombia. también es importante
encarga de la vigilancia establecer normas sobre
posmercado y de auditar los productos importados
sistemas de calidad de los (que son la mayoria). Otros
fabricantes y condicion de temas relevantes son la
calidad de los importadores trazabilidad y el manejo de
de los dispositivos médicos los dispositivos médicos
en Colombia. También en el territorio nacional,
existe la Dirección de al igual que el manejo y la
Dispositivos Médicos y aprobación de los equipos
otras Tecnologías. repotenciados, su control y
uso (este mercado necesita
formas alternativas de
control, la definición de los
requisitos para su uso, etc.).
Comoros Inspection Général de la — La Evaluación de Tecnologías — —
Santé. se reglamentó en el año 2011
mediante la Ley 1438, la cual
será competencia del Instituto
Nacional de Evaluación de
Tecnologías que está en
proceso de creación.
Congo — La Nomenclature officiel n'existe L'achat des dispositifs — —
pas. Mais sinon, on utilise ce qui médicaux est décentralisé. il
peut etre à la portée de la main peut se faire au niveau national
et selon les circonstances. comme à l'étranger.
Cook Islands — — — — —
A29

or reimbursement
Costa Rica AMR — — Existen protocolos y Two entities perform HTA: Caja
procedimientos para las Costarricense de Seguro Social
enfermedades y situaciones de (CCSS) and DDCTS. The extension
emergencias en mención, pero of the HTA entities is at subnational
no existen listas de dispositivos level, not at national level.
médicos como tales.
Côte d'Ivoire AFR Les listes d'acquisition provient du Document de travail de la Les procédures et directives sont —
Plan National de développement Direction des Infraestructures, dans le mannuel de directives à
Sanitaire PNDS. de l'Equipement et de l'attention du personnel des des
la Maintenance (DIEM): établissemnts de soins. il n'existe
ListeTypeEquip CHR_HG_CSU_ pas de liste spécifique à un domaine
CSR . ou un programme de santé.
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specifications:
Costa Rica El Ministerio de Salud The GMDN has been adapted to La Caja Costarricense de El Ministerio de Salud cuenta Es díficil que las instituciones
tiene a su cargo el registro the national needs. Seguro Social brinda cobertura con la base de datos de den cierta información que
y control del equipo universal a la población y es el los productos de equipo consideran es confidencial,
y material biomédico mayor proveedor de servicios y material biomédico por el ejemplo: el acceso a
mediante el Reglamento de salud del país, tanto en registrados para el país. Para sus inventarios de equipo.
Nº 34482-S para el uso, hospitales, clínicas y áreas de cualquier adquisición dentro En el caso de la Caja
registro, clasificación, salud, por lo que se considera del país es necesario contar Costarricense de Seguro
importación y control que hace la adquisición a con su registro, pero no es Social, que es el mayor
de equipo y material nivel nacional. También hay del tipo inventario pues no se prestador de servicios de
biomédico. El Sistema adquisiciones en el sector contabiliza; el registro tiene salud del país, se pudo
Integrado de Compras privado de dispositivos cinco años de vigencia. En el obtener dicha información
Públicas sigue la regulacion médicos en menor escala; de caso de la CCSS (ver|https:// con las autoridades
vigente para hacer sus esta última no se tiene acceso www.ccss.sa.cr/ ) se tiene un correspondientes, pero
respectivas compras de al inventario. inventario por establecimiento resulta complicado.
productos de salud. (en los tres niveles de
atención) tanto a nivel
hospitalario como en clínicas
y áreas de salud. Del sector
privado se ha reportado que
cuentan con inventarios de
equipos por institución, sin
embargo no se tiene acceso a
ese inventario pues se maneja
como información discrecional
en algunos de los casos y
es difícil de monitorearlo en
su totalidad. En el Ministerio
de Salud para el registro de
equipo y material biomédico
se utiliza el programa Visual
Basic 6.0, Base de datos SQL
Server 2005; mientras que
en la Caja Costarricense de
Seguro Social se utiliza el
programa ACCESS para la
gestión del equipo médico.
Côte d'Ivoire — — Il s'agit du Guide de la Direction La base nationale de données —
des Marchés Publics. n'est pas fonctionnelle.
A31

or reimbursement
Croatia EUR — — In 2007 the Ministry of Health and HTA is focused on pharmaceutics, not
Social Welfare issued Ordinance specifically in medical devices. HTA
on the organization and work has three partners: the MoH, Health
procedures of the Ministry of Insurance Fond (HIF) and Croatian
Health and Social Welfare's Institute of Public Health (CIPH).
Crisis Headquarters (http:// However systematic use of HTA to
narodne-novine.nn.hr/clanci/ support healthcare decision-making
sluzbeni/2007_05_46_1563.html) is in still in process, but expected over
which determines organization the next years.
scheme and work procedure of
the Ministry of Health and Social
Welfare's Crisis Headquarters as
well as actions of other health
care institutions and private
health workers in case of major
crisis. Major crisis is described
as any event which constitutes a
serious threat to health of a certain
community and results (or might
result) in large number of victims
who cannot be taken care of by
usual work organization of public
and private health care institutions
or private health workers.
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specifications:
Croatia — As per regulation 2017/45 on Ministry of Health and Social The Ministry of Health and —
medical devices and Regulation Welfare currently conducts Social Welfare has a national
(EU) 2017/746, the EU Member joined procurement of several informal and internal inventory
States Competent Authorities of groups of medical devices for medical devices in all
MD representatives (of both the for more than 20 hospitals public health institutions.
national MoH and the national in the Republic of Croatia. This inventory is used mainly
agencies) of the MDCG, have The procurement procedure for analytical purposes and
opted for the publicly available, is managed by the expert planning strategies within
accessible and transparent divisions within the Ministry the Ministry. In 2008 Croatian
nomenclature named European in collaboration with all National Institute of Public
Medical Device Nomenclature hospitals included in the Health, as part of a pilot
(EMDN) Procurement Plan and top project under EUROSTAT
medical experts for every guidelines, made an inventory
group of the equipment. Due of 10 most expensive medical
to continuous advancement in devices (MRI, Computed
medical devices technology, a Tomography, Linear
special commission is formed Accelerator, etc.).
before every procurement
procedure. The commission
defines the required technical
specifications of the device
based on the most recent
available data.
A33

or reimbursement
Cuba AMR — Existe un listado de modelo de Cada especialidad médica tiene It also exists the Department of
equipamiento médico destinado establecidas normas y programas a Innovation and Evaluation of Health
para cada nivel de atención. No través de las recomendaciones de Technologies attached to the
está refrendado en ninguna web los grupos nacionales y apoyo del National Directorate of Science and
(no disponible). Consejo de Sociedades Científicas. Technology of the Ministry of Public
En cuanto a las listas para diferentes Health (MINSAP). Evaluations are
enfermedades y/o situaciones no made mainly for pharmaceutics not
están refrendadas en ninguna web for medical devices.
(no disponible).
Cyprus EUR — — — Pharmaceutical Services within the

Ministry of Health performs HTA
evaluation of pharmaceutics.
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specifications:
Cuba En el caso de los medios de It is use the SUCNEM, Basado en la política de salud, El Programa de En términos de aclaración
diagnóstico in vitro, estos a nationally developed los equipos médicos deben Informatización de la Salud general indicamos que en
son regulados y atendidos nomenclature, based on the contar con el Registro Sanitario se encuentra en fase de Cuba, como es conocido,
en el Centro de Control Universal Medical Device para su utilización en el Sistema desarrollo. There are 3 types el Sistema de Salud
estatal de Medicamentos, Nomenclature System (UMDNS) Nacional de Salud (see: www. of inventory for medical tiene características de
Equipos y Dispositivos and the Global Medical Device bvscuba.sld.cu) y en la Gaceta equipment: National for ser único, centralizado,
Medicos (CCEEM). Nomenclature (GMDN) Oficial de la República de Cuba high cost technologies público, gratuito y
(www.gacetaoficial.cu). Para (such as MRI, CT or PET universal, refrendado
el proceso de importación se scanners), National for en la Constitución de la
realiza una evaluación entre medical equipment and República. La demanda
las autoridades competentes National functional for medical de equipos médicos se
donde se efectúa previamente equipment. realiza sobre la base de
un análisis entre asistencia requirimientos acorde al
médica y electromedicina. La desarrollo científico-técnico
fichas técnicas para facilitar mundial y de los índices de
el proceso de adquisición no consumo para los insumos
están publicadas. y obedece a las políticas
sanitarias establecidas.
Con relación al 3.3.1 las
Directrices se basan en la
Resolución del Ministerio
del Comercio Exterior No.
15 del 2006, no obstante se
conocen las Directrices de la
Organización Mundíal de la
Salud.
Cyprus — As per regulation 2017/45 on Procurement guidelines apply — —
medical devices and Regulation to the Public Sector only.
(EU) 2017/746, the EU Member
States Competent Authorities of
(EMDN)
A35

or reimbursement
Czechia EUR — — — There are HTA activities in
pharmaceutics, not specifically for
medical devices.
Democratic SEAR — — — —
People's
Republic of
Korea
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specifications:
Czechia — As per regulation 2017/45 on — — —
medical devices and Regulation
(EMDN)
Democratic — — — — —
People's
Republic of
Korea
A37

or reimbursement
Democratic AFR Il existe des listes de materiel dressé — — —
Republic of au niveau periphérique approuvé
the Congo (district sanitaire ). Pour le niceu
intermediaires et niveau tertiaire
cette liste est en élaboration.
Denmark EUR — — In the case of lists for different —

diseases and situations, there
are some more general plans,
but no specific medical devices
recommended.
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specifications:
Democratic La Direction des laboratoirs La nomenclature officielle En R.D.Congo, les achats se On est dans le processus de En tant pays post-conflit,
Republic of de Sante veuille surtout n'existe pas. Tout ce qui est font à tous les niveaux. L'Etat creér de pool de maintenance dans le processus de
the Congo au respect des normes de à portée de main et selon les n'a pas pu reglementer ce avec des ingenieurs sanitaires l'organisation de son
autres equipements des circonstances est utilisé. secteur les achats se font à et de rehabiliter les ateliers qui système national de santé,
laboratoires et des services tous les niveaux et surtout les existent . Il y a un programme le gouvernement dispose
d'imagerie medicales. bailleurs de fonds pour leurs de formation des ingenieurs et dejà d'une strategie de
Tandis la Direction des programmes spécifiques qu'ils des utilisateurs. renforcement du système
Equipements et Materiels appuient. Le directives à ce de santé qui est une
Medicaux s'occupes des niveau sont fonction d'un appel strategie sectorielle. Ensuite,
autres materiel medicaux offre, c'est en ce moment que le pays vient de se doter
et non medicaux . Un autre celui qui lance l'offre dresse un d'un plan stragegique de
organisme non du ressort certains critères des dispositifs développement sanitaire
de la santé, c'est le Comite qu'il veut acquerir. pour 5 ans avec un cadre des
National de Protection dépenses à moyen terme ou
Contre les Rayonments toutes ces technologies sont
Ionisants (CNPRI) qui planifiées.
s'occupe essentiellement
des equipements émettant
des rayonnements non
seulement médicaux mais
tout. Il faut dire qu'il y a
manque notoire des textes
qui doivent réglementer
tout ceci . C'est avec les
quelques notions appris
par ici et par là qu'on
essaye de faire tant qu'on
peut . Sinon, le secteur est
très peu reglementé ou
carrément non reglementé.
Denmark — As per regulation 2017/45 on — The National Institute of The National Board of Health
medical devices and Regulation Radiation Protection is is issuing some Health
(EU) 2017/746, the EU Member in charge. The inventory Technolgy Assessments,
States Competent Authorities of covers all x-ray equipment, including but not limited
MD representatives (of both the equipment for nuclear to medical devices. Only a
national MoH and the national medicine and radiation minority of technologies are
agencies) of the MDCG, have therapy. handled, so this is regarded
opted for the publicly available, as being outside the scope
accessible and transparent of the Policy section.
(EMDN)
A39

or reimbursement
Djibouti EMR — — — The development of the HTA unit
is in progress, as well as the human
resources to fill the workforce gap
within the MoH.
Dominica AMR — — — HTA activities have been identified,
but there is not a specific national
unit.
Dominican AMR — — — —
Republic
Ecuador AMR — Estatuto del MSP; Licenciamiento Reglamento para el registro y There are HTA activities for health
por Area en el I y II nivel. control sanitario de dispositivos products, not specified for medical
médicos; reactivos bioquímicos y de devices.
diagnóstico y productos dentales.
Reg. Oficial 573 del 20 de abril de
2009.
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specifications:
Djibouti — — — — —
Dominica — — — The Software is currently A manual exists in draft

awaiting for the setting-up. form to govern issues
related to medical devices.
It is still supposed to have
a final review to begin the
process of it's adoption and
implementation.
Dominican La Ley General de Salud No existe una nomenclatura En cuanto a la adquisión solo — —
Republic 42-01 y el Reglamento de oficial. Sin embargo, existe existen recomendaciones
Medicamentos Decreto una propuesta que data del dadas en fichas técnicas y de
246-06 son el marco legal año 2006 que respondió a un acuerdo a la complejidad del
que fundamenta el accionar proyecto de mantenimiento establecimiento.
del Viceministerio de preventivo de equipos médicos.
Garantía de la Calidad.
Ecuador Eco. Ruth Lucio, For MD traceability purposes Las políticas de adquisición Se está actualizando el La regulación y el control de
Coordinadora Nacional de will be taken as a reference están en proceso de inventario de los Hospitales la publicidad de dispositivos
Desarrollo Estratégico en the Universal Medical Devices implementación por la declarados en emergencia. médicos se realiza mediante
Salud Dirección Nacional Nomenclature System (UMDNS) Dirección de Inteligencia Hay "National inventory only el "Reglamento para la
de Vigilancia y Control developed by Emergency Care y Economía de la salud. for high cost technologies publicidad y promoción de
Sanitario en lo relativo a Research Institute (ECRI). In |Programa Mi hospital: (such as MRI, CT or PET medicamentos en General,
Publicidad y vigilancia. case that UMDNS does not Adquisición de equipos para scanners)" tambien. Productos Naturales
Dr. Liliana Sacoto es la have a specific code for a MD, 8 hospitales declarados en procesados de uso
Directora Nacional. Asi it will be taken as an alternative emergencia sanitaria. medicinal, medicamentos
como la Dra. Amelia Prieto nomenclature, the Global homeopáticos y dispositivos
del Instituto Nacional de Medical Devices Nomenclature médicos". Reg. Oficial 416,
Higiene y Medicina Tropical. developed by GMDN Agency. acuerdo ministerial 179 del
30 de marzo de 2011.
A41

or reimbursement
Egypt EMR — Were counted by the sector — A pharmacoeconomics unit was
ministry and therapeutic officially established in 2011 under
medicine, the National the Central Administration of
Information Center Ministry Pharmaceutical Affairs within
the Ministry of Health, but HTA
is not obligatory for pricing or
reimbursement. However, the recent
universal health insurance law from
2018 mandates the representation of
health economists in the governing
boards of the new Universal Health
Insurance Authority and the health
care provider body.
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specifications:
Egypt — Used in the database of Management of medical Database of geographical Concerning the
geographical information system equipment and hospital information system health. Infrastructure section: the
health. management. Curative proposed names are not
medicine sector and totally compatible with ours.
management of medical Thus, the number of units is
devices. under the Ministry of Health
only and is not confined to
Tfsalia to the private sector
in 2010.
A43

or reimbursement
El Salvador AMR — Norma técnica para el diseño y Tomadas de la pagina web del —
equipamiento de Casas de Salud. MINSAL (ver link proporcionado).
Norma técnica para radiología
diagnóstica e intervencionista;
Norma técnica para uso de fuentes
radiactivas en braquiterapia;
Norma técnica para la operación
de equipos de teleterapia; Norma
técnica uso de fuentes radiactivas
no selladas en medicina nuclear;
Norma de procedimientos de
control de calidad para equipos
de rayos-x de uso en diagnóstico
medico y dental; Norma técnica
sobre anestesiología P.I; Norma
técnica sobre anestesiología P.II.
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specifications:
El Salvador El departamento está El catálogo desarrollado es de — Para el control de equipos Las respuestas
a cargo del Dr. Rivera, equipo médico en general y sólo con fuente de radiaciones proporcionadas
Director de Regulación y es para fines de compra. No ionizantes, la Dirección corresponden
Legislación en Salud del existe distinción o clasificación de Regulación a través de exclusivamente a la
Ministerio de Salud. de equipos de tecnología médica la Unidad Reguladora de información disponible en
por su aplicación o incidencia en Radiaciones Ionizantes la Unidad de Proyectos
la salud del paciente. (UNRA) tiene el inventario de del Ministerio de Salud
los equipos como TC, Rayos X, Pública y Asistencia Social.
Angiografía, Gamma Cámara, Agradecemos permitirnos
etc. Autorizados a nivel participar de tan importante
nacional en la actualidad, se encuesta que nos permite
remitirá el listado actualizado establecer un enlace que
a la fecha a la OMS. estamos seguros contribuirá
a mejorar nuestra gestión en
la planificación, evaluación,
adquisición y mantenimiento
de los dispositivos médicos
de nuestro sistema nacional
de salud; así como a
contribuir en el desarrollo
de una política nacional
de tecnología sanitaria en
El Salvador. Este trabajo
servirá de referencia mundial
en materia de tecnologías
sanitarias, en particular en
lo que se refiere a políticas,
gestión, regulación y uso
de dispositivos médicos.
Esta encuesta se convertirá
en la información de base
para las actividades con que
se llevarán a la práctica las
intervenciones que prevea
la OMS en respuesta a las
peticiones de los Estados
Miembros, de acuerdo con lo
establecido en la resolución
sobre las tecnologías
sanitarias aprobada en 2007
(WHA60.29). Nos ponemos
a su total disposición.
A45

or reimbursement
Equatorial AFR — — — There are identified HTA activities but
Guinea not a national unit.
Eritrea AFR — Ministry of Health, Department — —
of Regulatory Services, Medicine
and Medical Devices Control
Division.
Estonia EUR The list about reimbursed medical — Recommended medical devices for The HTA for medical products, mainly
devices used in outpatient specific procedures are described pharmaceutics, and treatments. There
conditions is available on web-site in diagnostic (and treatment) is mention of medical equipment too.
(second link) Medical devices used guidelines. They are composed
in inpatient conditions are financed and/or approved by specialists
though the prices of healthcare organizations.
services (these prices include also
costs of workforce, area, etc). List
of healthcare sevices is available on
web-site (third link).
Eswatini AFR — — The list is still being developed There is no HTA national unit per
by the Emergency Preparedness se. However, and adaptive HTA
Group. has been used to inform in areas
such as benefits package in health
interventions prioritisations packages.
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specifications:
Equatorial — — — — —
Guinea
Eritrea — Official nomenclature system for — National medical devices —
medical devices is currently on inventory on the six zones
the process of development. has started in 2008 and,
currently, it is in the process of
finalization (only one zone is
partially remaining).
Estonia — As per regulation 2017/45 on The procurement of medical — —
medical devices and Regulation devices is regulated by the
(EU) 2017/746, the EU Member Public procurement law, as well
States Competent Authorities of as all other commodities (see
MD representatives (of both the specified website: riigiteataja).
(EMDN)
Eswatini — — The National guidelines Though this inventory is Concerning the
on procurement are yet still under development, we Infrastructure section: In
to be developed. The unit have only covered hospitals Swaziland Health Centres
together with the bio-medical and health centres and will may have more than 20
department forms a committee proceed to clinics (health beds. The referral levels
that recommends purchasing posts for Swaziland). are being defined by the
the needed equipment or rather ongoing essential health
requested equipment. care package that is being
developed.
A47

or reimbursement
Ethiopia AFR We have capital and routine The list of healthcare facilities is A revision has started for each. It is An HTA unit is not yet established.
medical device list with technical currently in progress. use the WHO guidelines and other Within the FMoH the Pharmaceutical
specification categorized with documents. and Medical Device Directorate and
health facility level. HEFA team are primary driving forces
to generate and promote HTA based
evidence. The HEFA team is tasked
with spearheading the application of
evidence-based health care decision
making by organizing available
evidence, costing interventions, and
defining effectiveness measures of
the different health programs and
then supporting policymakers at the
national and regional levels.
Fiji WPR The biomedical catalogue for CSN & CSP lists can be obtained CSN & CSP. Can be obtained from —
procurement can be obtained by from ministry of health, HQ. Ministry of Health, HQ.
the Fiji Health Sector Improvement
Program (FHSIP).
A48
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specifications:
Ethiopia Radiation & Protection Nationally developed and The Plan, Monitoring and AAU, Tikur Anbesa specialized Concerning National policy
Authority. adapted from both UMDN Evaluation Directorate (PMED), Hospital update medical on health technology:
and GMDN. This nomenclature within Federal Ministry ofHealth Inventory and Equipment National Medical device
is done by EPSA, ESDA and (FMOH) is in charge of the history file in 2013. strategy under development
FMoH in collaboration with procurement. (draft) and National Medical
skateholders. The nomenclature device directive (final draft)
is mainly use for procurement will approved within 3 or
and regulatory purposes. 4 months. Concerning the
Established the Public HT national policy, it is
Infrastructure Directorate are stated in the corresponding
now started inventory to identify National Health Policy
the type, source and status of document. Concerning the
the devices. Infrastructure section: the
targets of the government
are to expand the current
infrastructure capacity.
Fiji Also, supported by the — Mainly standardization of all BME Equipment Inventory. —
divisional biomedical medical equipment as per the The inventory has more than
engineering units. national biomedical catalogue. 8,600 items.
Also, supported by the Ministry
of Health central procurement
centre at Fiji Pharmaceutical
Services.
A49

or reimbursement
Finland EUR — — — —
France EUR La liste des dispositifs médicaux — — There are three commissions: La
et prestations pris en charge par commission de la transparence (CT);
l'assurance maladie est accessible à la commission nationale d'évaluation
l'adresse donnée en ameli (chercher des dispositifs médicaux et des
fournisseurs-de-biens-medicaux/ technologies de santé (CNEDIMTS),
exercer-au-quotidien/liste-des- and la commission évaluation
produits-et-prestations-lpp/liste- économique et de santé publique
des-produits-et-prestations-lpp/). (CEESP).
Gabon AFR — — — HTA activities have been identified,

unit per se. Currently, the HTA unit
is in progress towards the Universal
Health Care (UHC) country goal.
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specifications:
Finland — Finland CA will implement — — —
the European Medical Device
Nomenclature (EMDN) used
by manufacturers/ARs when
registering their medical devices
in the EUDAMED database. The
EMDN system will be based on
the Italian CND nomenclature
system. This will be the only
official nomenclature system for
medical devices in Finland.|Also,
some other commercial
nomenclature systems are used
in healthcare organizations
and health technology
companies.|Healthcare
organizations use these
nomenclatures in, for example,
public procurement, product
information retrieval, ERP, and
cost accounting.
France — As per regulation 2017/45 on — — Dans cette enquete, nous
medical devices and Regulation avons mentionnées la HAS
(EU) 2017/746, the EU Member et l'ANSM qui sont deux
States Competent Authorities of agences qui sont chargées:
MD representatives (of both the |HAS: Agence d'évaluation
national MoH and the national des dispositifs médicaux
agencies) of the MDCG, have |ANSM : Agence nationale de
opted for the publicly available, sécurité du médicament qui
accessible and transparent est chargée de la sécurité
nomenclature named European sanitaire des dispositifs
Medical Device Nomenclature médicaux.
(EMDN)
Gabon — — — — —
A51
e

or reimbursement
Gambia AFR — — — HTA activities have been identified,
but there is not a specific National
unit. Currently, the HTA unit is in
progress towards the Universal
Health Care (UHC) country goal.
Georgia EUR — — Governmental decree #153, 2007. State Regulation Agency for Medical
Activities is in charge of HTA but not
Germany EUR — — — —
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specifications:
Gambia — The Medical Research Council — Recently inventories have Concerning the
(UK) unit "the Gambia" (refer to been compiled for the Infrastructure section:
specified link) uses the UMDNS National Laboratory Services. the private sector section
system via the ECRI Health However, those for Hospital/ correspond to the
Devices Sourcebook (ECRI Clinical equipment are not responses for the Medical
website). Note that this is not available yet. The Medical Research Council (UK)
used by the Ministry of Health. Research Council (UK) the the Gambia; Concerning
Gambia has a full inventory HT nactional policy we
of its biomedical equipment. provide the following doc.:
It is comprised of 1,500 Medical Equipment and
devices including minor Devices Policy 2010 March.
clinical equipment, high- doc. Concerning Section
cost diagnostic and research Infrastructure: We have 3
laboratory equipment. We CHU and 1 Hôpital national.
use a proprietary equipment
management program from
Phoenix Data Systems Inc.
called AIMS (www.goaims.
com).
Georgia Georgian National According to Georgian — Nuclear and Radiation —
Agency For Standards, legislation, Georgia recognizes Safety Service, Ministry of
Technical Regulations and international or national Environment and Natural
Metrology is responsible (according on a list of certain Resources.
for standartization countries) certficates of medical
and metrology as well devices there.
as calibration and
accreditation of facilities,
providing inspection of
medical devices.
Germany There are more than As per regulation 2017/45 on — — Germany does not complete
30 regional Competent medical devices and Regulation the whole survey because of
Authorities. (EU) 2017/746, the EU Member their federal system, which
States Competent Authorities of will imply to make the whole
MD representatives (of both the survey in their 16 states.
national MoH and the national Regarding the Regulations
agencies) of the MDCG, have section: they follow the EU
opted for the publicly available, system, other matters are
accessible and transparent state´s competency.
(EMDN)
A53

or reimbursement
Ghana AFR The standard list serves as a — — There are identified HTA activities
guide. The actual procurement but there is not a national unit per se.
is based on the need of health HTA structures (Steering Committee,
facility, availability of utilities, and Technical Working Group and
availability of professional user staff. Secretariat) in the MOH have been
set up| and a national HTA strategy
developed and yet to be launched.
In progress towards the Universal
Health Care country goal.
Greece EUR — — — Various HTA institutions are

performing a variety of domains
Grenada AMR The list can be requested from — No lists available. —

the management of the Hospital
services. However there is no web to
guideline because was never used
as a policy of the MoH.
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specifications:
Ghana The Radiation Protection — The Ghana National Most inventories are held at a There is no written nor
Institute is responsible Procurement law as well as regional and an institutional published national health
for the regulation of the Ministry of Health (MoH). level. We are yet to acquire the technology policy yet but
equipment with radiation Depending on the value of software for the management there are policies available
sources such as X-Ray the procurement package, the of the inventory at the national that have been established
machines. health facilities are allowed level. by the systems and
to procure sometimes, the structures unit for health
unit of the MoH also procures technology in Ghana. Ghana
some of the capital equipment Health Service has drafted
especially from other projects. its operational policy for
All procurement of medical healthcare equipment and
devices is carried out with the needs to be finalized.
technical support of the Clinical
Engineering Department of the
Ghana Health Service or the
Biomedical Engineering Unit of
the MoH.
Greece — As per regulation 2017/45 on The EU Directive for public "Praxis", was developed by —
medical devices and Regulation procurement and national the Institute of Biomedical
(EU) 2017/746, the EU Member specific legislation for health Technology (INBIT), and it
States Competent Authorities of procurement (law 3580/2007). is a specific one. Also, it is
MD representatives (of both the A part of procurement of used the Asset Management
national MoH and the national medical devices is carried out Software.
agencies) of the MDCG, have at a national level, by the Health
opted for the publicly available, Procurement Committee.
(EMDN)
Grenada — A system was develop but it was There are procurement The inventory for all medical —
not supported by management. guideliness but they are not equipment in the island can
There is no URL because this implemented or followed. The be found in the Biomedical
software was locally developed. procurement of medical devices Engineering Department,
are carried out at a national General Hospital. The system
level by the Central Medical was locally developed,
Stores Unit (CMS). No specific installed and called The
devices have been selected but Medical Device Management
the needed assessment was System Software.
done.
A55

or reimbursement
Guatemala AMR — — Ver: Norma Técnica Vigente para HTA activities have been identified,
inscripción sanitaria de dispositivos but there is not a specific national
médicos. Específicamente la unit. Currently, the HTA unit is in
Normativa 37. progress towards the Universal Health
Care (UHC) country goal. There are
the following units: Planificación
Estratégica (SIGSA), Observatorio
en Salud Reproductiva (OPSOMS/
OSAR) y Sistema Informático de
Gestión (SIGES).
Guinea AFR — — Les Normes ont été définies —
pour les formations sanitaires de
base (postes, centres de santé),
les Centres de santé améliorés,
les Hôpitaux préfectoraux /
districts sanitaires et les Hôpitaux
Régionaux. Ces normes ne sont
pas disponibles pour toutes les
unités fonctionnelles des hôpitaux
nationaux.
Guinea- AFR — — — —
Bissau
Guyana AMR — — — —
Haïti AMR — — — —
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specifications:
Guatemala — La Clasificación In Vivo y según The procurement is done, at No se utiliza ninguno. —
Clase se encuentra contemplada general level, by the Sistema
en el Anexo de la Norma Técnica de Adquisiciones del Estado de
No. 37. Guatemala.
Guinea — — For procurement or L'inventaire disponible n'est —

donnations: nous procédons pas exhaustif en ce qui
par appel d'offres national ou concerne tous les dispositifs
international. medicaux actuallement utilisés
Guinea- — — — Inventário Nacional de —

Bissau Equipamentos Médicos:
Trabalho curso e dados
parciais para o sul do País.
Guyana — — — There are inventories for —
X-ray equipment. One public
corporation uses an assets
software to carry out the same
function.
Haïti — — — Il n'existe pas encore une Concerning the
liste d'inventaire technique Infrastructure section: les
national pour les equipements centres de santé sont dotés
medicaux. de 10 lits.
A57

or reimbursement
Honduras AMR — — — HTA activities have been identified,
unit.
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specifications:
Honduras — El Reglamento para el Control Ley de Contratación del Estado El inventario es por Objeto de —
Sanitario de Productos, y Reglamento de Ley de Gasto. Existe el SIAFI que es
Servicios y Establecimientos Contratación del Estado (more un sistema informático para
de Interés Sanitario, establece information under|https:// fines de presupuesto, el cual
una nomenclatura con fines de www.arsa.gob.hn/ ). Cada uno actualmente se encuentra
Registro. de los Programas de Salud en proceso de ampliación ya
dependientes de la Dirección que permitirá la gestión del
antes mencionada o entes equipamiento en todas sus
cooperantes realizan compras fases.
de dispositivos médicos para
proveer a nivel nacional,
como pueden ser pruebas de
laboratorio y anticonceptivos.
El Programa de Equipamiento
se elabora por demanda y por
complejidad.
A59

or reimbursement
Hungary EUR — — The uploaded Ministerial There are HTA activities for health
Decree lays down the minimum products, rarely for medical devices.
requirements for the provision
of healthcare services. The
criteria are equally specified for
healthcare facilities (1.2.1) and
specific procedures. The document
has been uploaded only once.
The decree is only available in
Hungarian. The assigned URLs
contain protocols for pandemic
situation according to the National
Influenza Pandemic Preparedness
Plan (second link). Also, see the
Decree 60_2003 on minimum
requirements of healthcare services.
Iceland EUR Only CE marked medical devices are — — —

approved.
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specifications:
Hungary — As per regulation 2017/45 on For procurement guidelines Under high-cost (amounts Concerning the HT policies:
medical devices and Regulation see the "Decree of the Minister exceeding EUR 400). "Safety and Partnership
(EU) 2017/746, the EU Member of Welfare" (No. 9/1993 NM) Unfortunately, the real state Program" -the health
States Competent Authorities of on the specific aspects of is not a public registry. The program adopted by the
MD representatives (of both the the financing of healthcare access is ensured only for Hungarian government
national MoH and the national insurance services.|In respect data providers, manufacturers on July 9th, 2008 - the
agencies) of the MDCG, have of certain medical devices and conformity assessment acceptance of medical
opted for the publicly available, procured at a national level over bodies. Most of the public devices and health
accessible and transparent a certain amount, procurement institutions use the software technologies into the social
nomenclature named European is carried out by the Central CT-EcoSTAT. insurance scheme was
Medical Device Nomenclature Services Directorate General defined in the context of
(EMDN) of the Prime Minister's Office. improvement of insurance
In the remaining cases, tasks until 2010. |Concerning
hospitals procure medical the HT units section: it has
devices subject to itemized been listed units that are
accounting individually and subordinated bodies but
the National Health Insurance not within the Ministry of
fund reimburses a certain level Health. Therefore, we found
of the costs (see the list in the it appropriate to mention
corresponding website, but them. |Concerning the
with exception of pacemakers, procurement of certain
heart valves, cochlear implants). medical devices: it is
performed centrally by the
Central Services Directorate
General of the Prime
Minister's Office. In respect
of certain medical devices
procured at a national level
and exceeding a certain
amount, the procurement is
carried out by the Central
Services Directorate General
of the Prime Minister's
Office.
Iceland According to Directives — — — —
93/42, 90/385 and 98/79.
A61

or reimbursement
India SEAR — — — HTAIN performs the evaluation
and appropriateness and the cost-
effectiveness of the available and
new health technologies. It includes
interventions, drugs, and medical
equipment. It has 12 research regional
hubs and several technical partners
around the country.
Indonesia SEAR — — We do not have lists for different It has been started the development
diseases/situations, but we use of HTA systems by establishing
WHO recommendations. nodal agencies and conducting
ad-hoc activities. Social Security
Management Agency for the Health
Sector (BPJS) is focus on HTA for
health products. Komite Penilaian
Teknologi Kesehatan (Komite PTK)
performs economic HTA (not for
medical equipment). HTA for medical
equipment is rarely performed.
Iran (Islamic EMR — — — The HTA office under the umbrella of

Republic of) the Ministry of Health and Education
(MOHME) was established in 2008, it
produces HTA over health products
and medical equipment.
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specifications:
India Notified medical devices — — — —
are regulated under the
Drugs and Cosmetics Act
and Rules under the 14
rule of medical devices
as notified under the
corresponding Act.
Indonesia — It is used a Harmonization We follow the Presidential Inventories are still ongoing. —
System code (HS) at the Decree No. 80 for general
moment. After harmonization procurement. Both, yes and no.
GMDN will be used. Yes, for vertical public hospitals,
procurement conducted at
national level. No, since re-
centralization, procurement of
medical devices at province/
district’s hospital conducted at
local level (province and district
level); see yanmed on the
website.
Iran (Islamic — — — — —
Republic of)
A63

or reimbursement
Iraq EMR The lists of medical equipments — — It has been adopted the EMA
have been announced on annual (European Medicines Agency) and
basis. the ICH (International Council for
Harmonisation for Pharmaceuticals)
performs health economics HTA.
Within the MoH, HTA is focused
on pharmaceutics not in medical
devices.
Ireland EUR There are also several National — — Additional HTA contact: laura_
Framework Agreement contracts dooley@health.gov.ie
for the supply of medical devices
and equipment. List of reimbursable
devices from Primary Care
Reimbursement Service (PCRS).
List of reimbursable devices from
PCRS is available at pcrs website
under -> online services -> list of
reimbursable items.
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specifications:
Iraq The company KIMADIA is The MoH is working on adapting The company provides storage, The Ministry of Health at a Data were obtained from
responsible for the bulk a national nomenclature system distribution and marketing central level keeps updated the annual report from 2010,
purchase of medicines, and linking it to the UMDNS. of medicines and supplies records on monthly basis for issued by the Department
drugs, medical supplies and for all Iraq where it is the the functional status of the of Planning and Human
equipment for whole Iraq sole importer of the public high-cost technologies. 2- Resource Development at
on behalf of the MoH. The sector as well as developing World Health Organization is the MoH Iraq.
regulations are pertaining the basic rules for setting the supporting the procurement
to the procurement prices for each class of drugs, of 3 CMMS (from GE - Asset
aspects. chemicals and medical supplies Plus) for three Central
to ensure the right price to Maintenance Repair shops
the citizens and pharmacies in Baghdad, Erbil and AL-
and the relevant authorities. Muthanna Provinces. 3- The
Works as well as the allocation Inventories for 6 provinces
of quantities of medicine out of 18 are completed and
(drugs and emergency life- 6 provinces will be supported
saving drugs) as well as the to carry out a functional
necessary supplies to be used inventory for their medical
in exceptional emergency equipment during the current
circumstances. In addition, to biennium 2010/11. Finally,
cover part of the needs of the MS Excel is been used at the
health institutions of medicine hospitals where inventory was
and supplies is through national carried out.
production.
Ireland — As per regulation 2017/45 on Portfolio & Category There are no national Concerning the
medical devices and Regulation Management approach inventories available to Infrastructure section: the
(EU) 2017/746, the EU Member involves the development of date. Inventories of medical breakdown of infrastructures
States Competent Authorities of medical devices/equipment equipment (including does not match to our public
MD representatives (of both the procurement strategies functional inventories) are sector. We have 7 Hospital
national MoH and the national at a national level and the maintained at a local level. Groups.
agencies) of the MDCG, have facilitation of regional and local Often there are separate asset
opted for the publicly available, decision making consistent management and medical
accessible and transparent with these strategies and equipment management
nomenclature named European accompanying procedures. inventories. There is an
Medical Device Nomenclature Go to the website and search initiative to compile this
(EMDN) for: services/Publications/ data into regional/national
corporate/procurementpolicy. inventories in the near future.
pdf. Health Service Executive There is no common software
(HSE). but a variety of systems are
employed including HEX, SAP,
MS Access.
A65

or reimbursement
Israel EUR List for procurement/reimbursement — It is in the Israeli legislation. The HTA within the MoH, as well as
It is part of the National Insurance research centers such as the Israeli
Law. Center for Technology Assessment in
Health Care (ICTAHC).
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specifications:
Israel Contact person: Avi Kravel — Technical specifications are — All the divisions and
within the Medical Devices available only in hardcopy. departments mentioned
department. in this survey are part of
the Medical Technology
Administration of the
Minisrty of Health in Israel.
The Administration is in
charge of the regulation,
licencing and policy making
regarding all medical
technologies in Israel
(including medical devices).
A67

or reimbursement
Italy EUR Documents are available at the — — Agenzia Nazionale per i Servizi
websites. Documents are often Sanitari Regionali (AGENAS)
updated, and many of them under performs HTA for medical devices,
revision. and Italian medicines agency (AIFA)
mainly in pharmaceutics and related.
HTA is also performed in research
institutes such as PoliclinicoGemelli
(last link).
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specifications:
Italy Addresse and contact CND Classificazione Nazionale Go to the website and look — —
of the Medical Devices dei Dispositivi Medici (correlated for: dispositivi/dispomed.jsp
Directorate: Via Molise with GMDN). CND was nationally documents.
2, 00187 Roma, Italy. Tel. developped, and it is the base
+390647051. for EMDN. As mentioned on
several occasions in the past, a
map of correspondence between
the GMDN nomenclature and
the Italian CND classification
has been created since 2007 to
allow manufacturers to register
in the Italian database of medical
devices. This map is subject to
ongoing maintenance even today
at the request of manufacturers.
This map was introduced at
the beginning because the
GMDN code was originally the
mandatory registration key in
the Italian system. Subsequently,
the mandatory use of the GMND
code was removed at the request
of the manufacturers, due to the
difficulty of using it and, in many
cases, due to its unavailability.
In any case, the possibility of
using the GMDN code and its
connection with the CND is
still allowed, but it appears
that, despite this possibility of
use, the GMDN code is rarely
used in the registration in the
Italian system.|A new version
of the Italian medical device
nomenclature (CND) will be
published within the next
months. Because the CND has
been chosen as the basis of the
EMDN nomenclature, a huge
update has been done to create
the European nomenclature.
A69

or reimbursement
Italy cont...
Jamaica AMR — — Not available at present. At the moment, the country does
not have an official process for
collecting evidence and preparing
HTA reports as an input for making
health coverage decisions, but they
are interested in working towards it..
Japan WPR New medical devices which begin to — — There are a medical technology
be reimbursed have been published evaluation team, an expert committee
by the Central Social Insurance for insurance care materials, an
Medical Council. expert committee on drug prices
(within the MoH: first link). Also, the
National Institute of Public Health
performs economic health evaluation
(second link).
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specifications:
Italy cont... All the updates have been
acquired in the new version
of the CND, that has been
approved by the Italian Technical
Committee on 21st December
2020.|One of the most important
inputs for the CND update was
the comparison with GMDN and
so an alignment between the first
level of the CND 2018 version
and GMDN (dataset 01/05/2019)
has been done. A list of GMDN
codes not covered by CND has
been defined and then used to
create some new codes in CND.
In the Meeting of the Medical
Device Nomenclature Working
Group-04, OCTOBER 2019 of the
European Commission, the state
of the art of mapping between
CND and GMDN was a point of
the agenda. Any further other
mapping activities must be
agreed upon with the European
Commission in line with the
provisions of the project itself.
Jamaica — — The procurement is done at — Concerning the HT national
regional and hospital levels. policy is stated in the
document Ritza 04.
Japan — Japanese Medical Device — — —

Nomenclature was developed
from the GMDN 2003 version.
A71

or reimbursement
Jordan EMR The list is not published. It is within — We have a list but for a specific Structured HTA capacity_building is
the updated document of the study departments, it is not published. being developed and implemented
department. It is only updated and kept in the in the Department of the Pharmacy
Study & Project Department. In the Center for Drug Policy and
near future it will be published the Technology Assessment (CDPTA),
Essential list at our website. King Hussein Cancer Center (third
link). Jordan started a hospital-level
HTA at King Hussein Cancer Center
(KHCC). The CDPTA at KHCC is
responsible for conducting HTAs,
their assessments are appraised
by the Pharmacy and Therapeutic
(P&T) Committee and HTA results
are currently utilized to support
formulary listing decisions.
Kazakhstan EUR For list of approved medical — — Additional HTA contact: Zaid
devices for procurement we have Zholdassov: zholdassov_z@
the Medical State Register of rcrz.kz. The HTA is focused on
Lekarstennyh. pharmaceutics, sometimes performed
Kenya AFR Lists are developed locally and — It only covers surgical procedures The development of HTA framework
available in hard copy only. Lists which are locally developed. No for health products is in progress.
for procedures only cover surgical available.
procedures.
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specifications:
Jordan It also exists the Energy This country will support the The procurement is done at — Concerning medical
& Minerals Regulatory WHO standard nomenclature a national level by Ministry of equipment management
Commission. for medical devices. Until now, Health. Some manufacturers section: we have around 700
its nomenclature is based on have guidelines and technical type medical equipment
UMDNS for management in specificatios such as: ECRI, tech., spec., updated only
the CMMS system, and the AAMI, HTM (See:|http://dbe. in tenders are published;
government procurement gov.jo). Although the list is not and we have 30 medical
department uses UNSPSC published neither available equipment, workshops MOH
nomenclature for procurement online, it's within the updated Hospitals.
purposes. document of the study
department.
Kazakhstan National center of Medical State Register of The procurement is done at a Medical State Register of Concerning the
examination of drugs lekarstennyh. national level with the register lekarstennyh. Infrastructure section:
(RGP), medical devices of procurement of medical the division for 20 beds
and medical equipment equipment. We have the on health centres is
nazancheniya (MH RK). National Register of medical not applicable for the
devices. Kazakhstan centres network.
Kenya Kenya has demonstrated The GMDN is used for regulatory The procurement at a national Locally developed. The corresponding technical
its commitment to improve purposes level is specifically done at the specifications, as well as
the national legal and Ministry of Health. Guidelines donation guidelines are
regulatory framework for for donations: IEC 60601, ISO available upon request in
radiation safety. Currenty, 13485, Directive 93/42/EEC. soft copy (not pdf versions).
The Radiation Protection
Board (RPB) regulates
such activities in Kenya,
including those with sealed
and unsealed radioactive
sources as well as X-ray and
other radiation-emitting
devices.
A73

or reimbursement
Kiribati WPR We do not have a standard list in — We do not have a standard list in —
place but we do overseas and local place but we do overseas and local
procurement for specific medical procurement for specific medical
devices needed for MoH; e.g., in devices needed for MoH; e.g., in
2009 overseas procurement for 2009 overseas procurement for
medical devices was made through medical devices was made through
medical healthcare prioritization medical healthcare prioritization
according to doctors and head according to doctors and head
nurses. The selection and orders nurses. The selection and orders
of medical devices were made to of medical devices were made to
medical suppliers (such as South medical suppliers (such as South
Austral and Braun) taking into Austral and Braun) taking into
account quality, affordability and account quality, affordability and
critical need to meet quality health critical need to meet quality health
care services and patient's safety care services and patient's safety
and satisfaction. and satisfaction. In 2010 (8/3/2010)
we received some medical devices.
Kiribati outbreak manual for public
health nurses and curative: national
pandemic guidelines, national
disaster guideline.
Kuwait EMR — — — It has been started the
institutionalizing of HTA within the
MoH, with activities such as the
building capacity.
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specifications:
Kiribati — — The donations are second-hand We have the inventory record Medical devices
medical devices from churches and monitoring system components such as tools,
(LDS & CCatholics); such as with medical stores/clinical knowledge, skills, repair and
defibrillator, computer, patient wards/community health maintenance are very crucial
monitor-propaq, dressing centres. In the case there and essential therefore
trolleys. is no inventory for specific Kiribati is very fortunate to
medical equipment we refer be part of this surveillance
to overseas medical supplier thus is the only way to
for assistance and good maintain our QA/QI (quality
advices. In some cases there assurance and quality
is inventory only for high cost improvement) to achieve
technologies (such as MRI, CT MoH objectives (utilization
or PET scanners). of quality medical/nursing
care to all Kiribati individual
patient/client to provide
patient's safety, quality
health care services and
patient' satisfaction). We
would appreciate being
advised in ongoing training
especially for nurses.
Kuwait — — — — —
A75

or reimbursement
Kyrgyzstan EUR Standards: The law on the Health Equipment timesheets are Clinical protocols. —
Care institutions. We have lists for available, but without the use of
communicable diseases, and public nomenclature.
health emergency situations, as well
as clinical protocols. The register
of registered medical equipment
is made at the website of the
Department of Drug Provision and
Medical Equipment MoH of the
Kyrgyz Republic.
Lao People's WPR — — — It has been started the development

Democratic of HTA systems by establishing
Republic nodal agencies and conducting ad-
hoc activities. There are identified
HTA activities but not national unit.
The creation of a national health
insurance authority towards the UHC
goal is in progress.
Latvia EUR — — Regulation of Cabinet of Ministers —
No. 60.
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specifications:
Kyrgyzstan — The nomenclature is used for Kyrgyz Republic National The National Register for —
various purposes: regulation, Health Care Reform Program Medical Equipment and the
procurement, in-vitro diagnostics “Manas taalimi”. Procurements National Functional Register
lists and inventory. are carry out through the for Medical Equipment.
National (budget) or donor The National Functional
projects. Register for the Medical
Equipment is a database
for medical facilities of the
public health institutions;
meanwhile, the National
Register of the Medical
Equipment is a national list of
pharmaceuticals and medical
equipment authorized and
registered for utilization in the
Kyrgyz Republic. A database
is employed for material and
technical facilities and medical
facilities of public health
institutions.
Lao People's There is the political will — The procurement at a national In the whole country, the —
Democratic to strenghten the Nuclear level is only for sophisticate and inventories are ongoing .
Republic and radiation safety high-value equipment.
and security, as well as
the corresponding legal
framework (as seen in the
2020-2025 plan).
Latvia — As per regulation 2017/45 on The procurement of national — —

medical devices and Regulation devices at a national level
(EU) 2017/746, the EU Member started from the year 2010.
(EMDN)
A77

or reimbursement
Lebanon EMR — — — The HTA is at initial stages to inform
health policy and products. National
strategy will incorporate several
actors: MoH, National Social Security
Funds, General Security, etc.
Lesotho AFR — — — —
Liberia AFR Lists of standards and lists — The list of equipment can be —
are: "Basic Package of Health found in the index of the following
Services" which contains a list of document Basic Package of Health
the equipment at the "annexe". Services. However, the list is subject
However, the list is subject to to revision.
revision. The WHO guidelines are
being used for donations. The
process has been initiated for the
adaptation of the guidelines.
Libya EMR There are national standards — There are national standards —
lists but they are not written. lists but are not written. It exists
There are lists for Sundries also lists for interventions, and
Hospital consumable- Diagnostics emergencies. See the following file:
Laboratory 37/3. General_terms_and_conditions_
for_medicines_and_medical_
consumables_and_equipment.
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specifications:
Lebanon It controls the importation The Ministry of Health is planning The procurement of medical The Ministry of Health has —
of all radiological devices to acquire the Global Medical equipment for public acquired a GIS licence to
(x-ray devices, tracers for Devices Nomenclature system to hospitals is done by the establish a database which will
nuclear medicine, etc.). adopt it and use it for regulatory Council for Development and include the available high-cost
and procurement purposes. Reconstruction in coordination technologies.
with the Ministry of Public
Health. A procurement
procedure and bidding
documents are used and
adapted according to the
specific project and considering
the government rules for
procurement. No guidelines
exist in the private sector that
is dominating the health sector
(80% of beds are private).
Lesotho — — — — —
Liberia Currently, there is No comments as the The procurements are based on The functional inventory of —
a National Drug nomenclature does not exist. the WHO guidelines and they medical equipment is ongoing.
Regulatory Authority are mainly organized through The focus is to take inventory
that is in the process of partners. of all equipment in the Public
institutonalization. Health facilties.
Libya The Medical Supply For the medical equipment list, it In regards to the technical The last version is from 2006. This is the first time for us to
Organization (MSO) is used a nomenclature based on specifications of medical participate in this survey. Our
is responsible for the the UMDNS. The nomenclature devices, we depend mainly on standards and policies are
procurement of medical is used for inventory systems of the technical committees which under development and/or
appliances for the public healthcare facilities and lists. consist of experts in medicine, being updated. Many issues
sector. pharmacy and biomedical in this survey are available
engineer. These committees but still not documented.
set up decrees issued by the “General_terms_and_
Secretariat of Health. conditions_for_medicines_
and_medical_consumables_
and_equipment”
A79

or reimbursement
Lithuania EUR Licensing regulations for health — These are lists of indications and —
care facilities. General and specific reimbursement regulations for
requirements for institutional health expensive health technology
care services. There is a list of examination techniques (e.g. CT,
medical devices that are mandatory MRI) and diagnostic procedures
for specialized and surgical health (e.g. diagnostic interventional
care services. Public Procurement procedures). Only available in
Office operating under the Ministry lithuanian language. General
of Economy, compiles the list and specific requirements
of drugs and medical supplies, for institutional health care
annually. The list is approved by services. There is a list of medical
the Minister of Health. The items devices that are mandatory for
included in this list are procured in specialized and surgical health care
a centralized way. The procurement services. There are no separate
expenses are disbursed from the lists of communicable or non-
National Health Insurance Fund communicable diseases.
Budget. The National Health
Insurance Fund under the Ministry
of Health is responsible for public
procurement of the items of the list,
mentioned above.
Luxembourg EUR — — Contenues notamment dans le plan —
pandémie grippale qui n'est pas sur
l'internet public.
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specifications:
Lithuania — As per regulation 2017/45 on Guidelines for procurement of The State Health Care —
medical devices and Regulation expensive health technologies Accreditation Agency,
(EU) 2017/746, the EU Member (i.e. MRI, CT etc.). Guidelines are under the Ministry of Health,
States Competent Authorities of in the Lithuanian language only. is responsible for the
MD representatives (of both the There are basic requirements management of national data
national MoH and the national for technical specification regarding expensive health
agencies) of the MDCG, have of medical devices that are technologies (i.e. MRI, CT,
opted for the publicly available, procured in a public centralized etc.).
accessible and transparent way.
(EMDN)
Luxembourg — As per regulation 2017/45 on — Software choisi par chaque —

medical devices and Regulation hôpital individuellement.
(EMDN)
A81

or reimbursement
Madagascar AFR — — — —
Malawi AFR The standard list provided is for — — —

health centres, community hospitals
and district hospitals. The standard
list for central hospitals is being
developed and will be published
very soon (file names: "jica" and
"customer", respectively).
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specifications:
Madagascar — Nomenclature nationale pour Specifications techniques pour: Inventaire effectué en 2007 Formation en maintenance
la comptabilité matière du Matériels et équipements pour avec le projet CRESAN 2 (55 biomedicale a Madagascar:
patrimoine de l'Etat (codification les Centres de Santé de base; Centre Hospitalier de District Depuis 1980, la multiplication
pour l'inventaire technique). matériels et équipements de de niveau 1 (CHD1), 29 Centres des établissements
laboratoire pour les Centres Hopsitaliers de Districts de hospitaliers et l'avenement
Hospitaliiers de Districts niveau 2 (CHD2), 18 Centres des nouvelles technologies
de niveau 2; matériels et Hospitalier de Référence au service de santé ont
équipements biomédicaux et Régionale (CHRR), 10 Centre induit une arrivée massive
hospitaliers pour les Centres Hospitalier Universitaire (CHU) et diversifiée d'appareillages
Hospitaliers de Districts de et Etablissements Sanitaires. biomédicaux et ont fait
niveau 2. Mise à jour en cours. apparaître le problème
crucial de leur maintenance.
La dernière action de
recyclage (formation
continue) des techniciens
date de 2001.
Malawi Radiation protection and — There are the following pdf The inventory is in a database —
nuclear safety is done via files: the "Public Procurement known as "Planning and
AERA and it is in process of Act (2003)", the "Desk Management of Assests in
institutionalization. Instructions", and the Health Sector (PLAMAHS)"
"Procurement Regulations". and is not yet online.
A83

or reimbursement
Malaysia WPR The corresponding lists are only — There is no standardized list. It is Malaysian Health Technology
prepared based on the needs. based on needs. Assessment Section (MaHTAS) of
the MoH performs HTA for health
products including medical devices.
Maldives SEAR — — — —
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specifications:
Malaysia The Medical Device Act — Depending on the types of — —
2012 (Act 737) has come Medical Devices. Some are
into force on June 30th procured at a national level,
2013, while the effective some at the state level and
date for its subsidiary some at the hospital level.
legislations, the Medical
Device Regulations (MDR)
2012 was on July 1th 2013.
Act 737 provides two and
one years, respectively,
of a transition period for
the industry to submit
applications for medical
device registration and
establishment licensing
before the law is fully
enforced. It exists a
separate unit for the
regulation of radiological
equipment (i.e. within
the Ministry of Energy):
Radiation Health and
Safety Section, Engineering
Services Division, Ministry
of Health Malaysia:|https://
radia.moh.gov.my/. The
Atomic Energy Licensing
Act 1984 (Act 304)
provides the regulation
and control of irradiating
apparatus.
Maldives — — The procurement is done at — —
a national level as well as for
government health facilities.
A85

or reimbursement
Mali AFR Il n'existe pas de normes nationales — Il n'existe pas de normes nationales The HTA is at initial stages to inform
pour des procedures spécifiques, pour des procedures spécifiques health policy and products but not
en général elles sont traitées au , en général elles sont traitées au for medical equipment.
cas par cas. Non, comme décrit cas par cas. Pour diverses maladies
précedemment, il n'existe pas et situations Il n'existe pas de liste
de liste spécifique de dispositifs spécifique de dispositifs médicaux
médicaux pour les cas cités. La liste pour les cas cités.
de dispositifs médicaux approuvée
est en fait par niveau de structures
sanitaires. A ce jour nous disposons
de listes standard d'équipements
pour les structures de base (CSCOM
- centre de santé communautaire)
et les structures de première
référence (CSREF - centre de santé
de référence) que nous utilisons
dans nos différents dossiers d'appel
d'offres d'acquisition de dispositifs
pour celles ci. Pour les hôpitaux
nous essayons d'harmoniser , car
les structures diffèrent un peu
,en fonction de la population, de
l'éloignement et de la position
géographique.
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specifications:
Mali — Il existe dans le document de Guidelines for procurement: Chaque année le Ministère Concerning the
la comptabilité matière une existe un document de projet de la santé à travers la DFM Infrastructure section:
rubrique nomenclature sommaire de politique nationale en organise des inventaires nous n'avons pas encore
ou les différents produits sont matière d’équipements et mixtes dans lesquels| une politique nationale
classés par catégories, mais c'est d’infrastructures sanitaires qui participent comptables pour les équipements mais
un domaine très important qui traite ces cas , mais il reste à matières et techniciens nous y travaillons, nous
mérite une action. être validé. Jusqu’à l’adoption biomédicaux, dans toutes avons tenu deux ateliers:
de la loi hospitalière. La DFM les structures sanitaires l'un pour l'élaboration des
était le seul organe d’achat du pays [centres de santé élements de la politique et
de dispositifs médicaux. communautaire (cscom) , l'autre pour la rédaction
Vue que cette loi accorde centre de santé de référence du document de politique.
un statut particulier à (csréf) et hôpitaux régionaux Le document attend sa
certaines structures sanitaires (HR).Ensuite les differentes validation lors d'un atelier
notamment l’autonomie de fiches sont compilées et national pour être soumis
gestion, mais aussi dans le informatisés au niveau de la à l'Assemblée Nationale.
cadre de la décentralisation il y division comptabilité matières. Concerning the Section
a le transfert de compétences Infrastructure: la Division
entre le Ministère de la établissements sanitaires et
Santé et les collectivités réglementation (DESR) à
territoriales, de sorte que ces la Direction Nationale de la
structures peuvent acheter Santé s'occupe également
indépendamment des établissements privés de
santé mais ne dispose pas
de données à jour (2010) sur
leur nombre exact.
A87

or reimbursement
Malta EUR — — — Office of the Chief Medical Officer is
in charge to perform HTA, mainly in
pharmaceutics.
Marshall WPR — — — —
Islands
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specifications:
Malta — As per regulation 2017/45 on Procurement at national level: The name of the Software The Ministry of Health has
medical devices and Regulation there is a strong collaboration is Clingo from the company started to provide emphasis
(EU) 2017/746, the EU Member between the two. For Carestream Health Italia SRL. on new health technology
States Competent Authorities of capital expenditure for new and its assessment. Over
MD representatives (of both the technologies it is usually the the last 2 years, it has been
national MoH and the national department, for others it is developed a short form and
agencies) of the MDCG, have usually coordinated by the guidelines for the completion
opted for the publicly available, hospital itself. of all the requests for
accessible and transparent the implementation of
nomenclature named European new health technologies
Medical Device Nomenclature and services. Together,
(EMDN) the Director Generals for
Strategy & Sustainability,
and Healthcare Services
have met three times a year
to evaluate the proposals
received. It is envisaged
that a health technology
evaluation unit will be
developed in the short term.
Marshall — — — Inventory is not available. —
Islands
A89

or reimbursement
Mauritania AFR — — Il existent des paquets d'activités —
par niveau des soins de la pyramide
sanitaire.
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specifications:
Mauritania Direction de la Medecine — Il existe un plan de passation Un inventaire technique Le suivi de la maintenance
Hospitaliere qui a des Marchés (search for the national etait diponible des équipements est
l'attribution de élabore et document admin07 in the dans une base de donnée une mission confiée à la
suit la reglementation et specified website). Il existe informatisée (GMAO) qui est Direction des Infrastructures,
les normes hospitaliere, le Centrale d'Achat des malheusement deectueuse du Matériel et de la
et prépare l'autorisation Médicaments, Equipements depuis 2004, et qui n'a Maintenance (DIMM) et mis
d'ouvertue a titre privé des et Consommables Médicaux jamais été actualisé au niveau en œuvre par le service de la
cliniques et des cabinets de (CAMEC) en ce qui concerne national. Maintenance.|Le service de
soins infirmier. Inspection la procuration des equipments la maintenance comprend
General de la Santé (IGS) medicaux:|http://www.camec. deux divisions :- Division
a l'attribution de verifier mr/ de la maintenance des
la gestion des activités de infrastructures;- Division
l'ensembles des services de la maintenance des
du departement et des équipements et des
organes sous tutelles, et matériels. Le service de
leurs conformité aux lois la maintenance dispose
et reglement en vigeur d'un plateau technique
cf voir organigramme du composé, au niveau
ministere de la sante qui se central de 7. techniciens
trouve dans le site web du biomédicaux, de 2 ingénieurs
ministere. biomédicaux et d'un
ingénieur électrotechnicien,
au niveau périphérique de
: 5 unités régionale, qui
assurent une maintenance
de proximité. La qualité
du service est insuffisante
dans la quasi-totalité des
structures de maintenance
lié à la perception même de
la composante maintenance,
qui n’est généralement pas
prise en compte lors de
l’élaboration des projets et
de certaines défaillances au
niveau du développement
des compétences (formations
spécialisées, stages de
perfectionnement pour
les experts etc.) et autres
moyens (financier, outillages
etc.) pour l’exécution des
activités de maintenance
(préventive, curative etc.).
A91

or reimbursement
Mauritius AFR Some lists are available for certain — Some lists are available for certain —
specific conditions e.g pandemic, specific conditions e.g Pandemic,
fogging, sprayers, etc. (an specific fogging, sprayers, etc. There is
Plan is in preparation), there are no no specific list for Communicable
specific lists for non-comunicable Diseases but a PLAN is in
nor communicable diseases. It must preparation.
be pointed out that the Ministry
does not accept all donations
except from friendly countries.
Mexico AMR See "cuadro básico". The list is The lists are updated constantly. — —
under new policies.
Micronesia WPR — — There are no lists available. The unit of Budget and Planning
(Federated with the department of finance and
States of) administration (DOFA) performs
economic analysis, however, there is
no HTA for medical products.
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specifications:
Mauritius Radiation Protection We import all our devices. Central Procurement Board Each hospital has a separate Concerning the HT national
Authority for Radiation. has a policy. However, there inventory. Concerning police it is stated in following
is an equipment committee Software there is one document: politique santé.
which looks after procurement developed locally which is
of equipment spare parts. For currently on trial. E-health is in
public sectorn procurement is preparation.
done at a level of the Ministry
of Health and the central
procurement board. Private
equipment is done by direct
purchase. In the public sector,
we recommend certification
based on the FDA, CE and TUV
approved systems.
Mexico — The nomenclature system is There are some Subsistema de Información —
established and organized in recommendations for this de Equipamiento, Recursos
charts for health technologies topic, but they are not policies. Humanos e Infraestructura
that can be used in public/ The specifications are only para la Atención a la Salud
social health services. As for the recomendations. (Subsystem of Equipment,
government administration for Human Resources and
2018-2024, the charts will be Infraestructure in Health).
organized as a compendium and There are not only one, in
it is in the process of depuration. general these are made in
each one of the units for their
particular needs.
Micronesia — — Medical devices may be The National Department of There is limited expertise in
(Federated purchased by the National Health and Social Affairs, as the country. There are no
States of) Department of Health & Social well as state health services, qualified radiographers nor
Affairs, or the State Health keep assets registries for fixed pathologists. Only 3 over 30
Services. At a national level assets over $1,000. Medical laboratory technicians have a
purchases are made by the Devices will be included on bachelors degree in medical
coordinator of the program these registers. Individual units laboratory science.
receving the grant or funds for (e.g. state laboratory) should
the purchase in consultation have a functional inventory of
with the department to receive devices/equipment.
the device (e.g. manager of
state hospital radiography
department, or chief of ancillary
services). Guidelines are only
for competitive quotes or
bidding processes.
A93

or reimbursement
Monaco EUR — — There are "Plans d'urgence". La Direction de l'Action Sanitaire
pourrait commander évaluations des
technologies de Santé.
Mongolia WPR — — — —
Montenegro EUR There is a list of medical devices — There are no national standards for There is no HTA framework yet, but
(based on the opinion of a team medical devices, but Competent positive political will.
of doctors) that are provided or Authority, in accordance with the
reimbursed to the patient by the law on medical devices recognize
Health Insurance Fond. The list appropriate international standards
is created as a result of different (EC, ISO). There is the Law on
indications mostly for treatment, Protection of Population against
alleviation or compensation for Communicable Diseases. Also,
an injury or disability. There is the we have National strategy for
Law on Protection of Population emergency situation, which involves
against Communicable Diseases. part about public health emergency
Also, we have a national strategy situations (see link). The lists are
for an emergency which is involved published in Montenegrin language.
as a part of the public health
emergencies policy (see link).
Morocco EMR Des listes standardisées de — Concernant les points "b" et "c" des Adopted EMA (European Medicines
dispositifs médicaux pour différents listes sont établies au niveau de la Agency) and ICH (International
établissements de soins sont DEM. La DELM prend en charge Council for Harmonisation for
établies au niveau de la DEM. les points "a" et "b" aussi (see Pharmaceuticals) guidelines.
comments of other lists). Inspector General Office performs
health economics HTA. Within
the MoH, HTA is focused on
pharmaceutics but not in medical
devices.
Mozambique AFR — — — The Department of Health
Information (DIS), Ministry of
Health (MISAU), performs HTA for
technologies related to prevention
and control of diseases, but no
specifically for medical devices.
Myanmar SEAR — — — It has started the development of
HTA systems by establishing nodal
agencies and conducting ad-hoc
activities.
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specifications:
Monaco — Directive 93/42/CEE. Procurement guidelines: Pas d'inventaire. —
marquage CE requis.
Mongolia — — — — —
Montenegro — “Register (notification) of The procurements of There are no specific national Concerning the
medical devices” that contains medical devices for public inventories but every year the Infrastructure section: We
information on medical health institutions are in Government of Montenegro would like to inform you that
devices which are available conformity with Law on public provides a specific amount we have specialized hospitals
for use in Montenegro has just procurements. We recognize of money that can be used in for only one speciality as
recently been set up. As it is international standards in special cases (public health psychiatric, orthopaedic and
at the start of its operations, accordance with a law on emergency etc.). lungs diseases. We have 3
it will use GMDN as a referent medical devices. institutions like this.
nomenclature system and based
on this, it will be developed
a system that will be in
Montenegrin language so that
all users can use it properly and
they will have information what
is on Montenegrin market as well.
Morocco — Nomenclature basée sur l'ECRI et Un projet de mise en place La majorité des inventaires —
le CNEH. d'une stratégie Nationale en des régions sont sur support
matière de gestion des T.S est papier et non encore
en cours. Les spécifications informatisé. L'alimentation
techniques sont établies selon de la base de données du
les besoins des utilisateurs progiciel de gestion des
(grands projets de CHUs) et dispositifs médicaux est en
standardisées pour chaque type cours.
d'établissement de soins.
Mozambique — — — — —
Myanmar — — The Procurement and In some cases, there is an —

Distribution Division, inventory only for high cost
Department of Medical Services technologies (such as MRI, CT
is in charge of procurement at a or PET scanners).
national level.
A95

or reimbursement
Namibia AFR — — — MoH uses HTA for both regulatory
and coverage purposes. Not
performed for medical devices.
However, an HTA has yet to be
elevated to the national agenda.
There is a written HTA. guideline, and
formal identification of technologies
for HTA.
Nauru WPR — — SPC assist us with our supplies for —

the Pandemic preparedness but we
do not have a list as most of these
are consumables.
Nepal SEAR — — — There are identified HTA activities

but not national unit per se. However,
there is research in the health unit
within the MoH. The HTA under the
government umbrella is in progress
and a requirement to reach the
Universal Health Care country goal.
Netherlands EUR The health insurance scheme takes — In the Netherlands, the professional —
care of the reimbursement of has to decide, recommend or
extramural medical devices in the indicate a medical device. The
Netherlands. The reimbursement cupola of the professionals can
of medical devices is function publish a guideline for specific
orientated. procedures. There is no national
policy on diseases or situations.
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specifications:
Namibia According to the Atomic — There are guidelines for Medical Equipment —
Energy and Radiation Implementation of the National Management System Software
Protection Act No. 5 of Health care Technology (MEMS).
2005. Policy & Medical Equipment
Management. Since finances
have been decentralised, each
of the 13 political regions is
responsible for budgeting and
procuring medical equipment
for the health facilities in that
region. Advise on budgeting
and tender specifications can
be obtained from MEM at a
National Level.
Nauru — — The procurement for the We keep an asset register —
medical devices is based on the at the Administration Office
Hospital's Senior Management and the Pharmaceutical Store
Team decision and the which include all the medical
availability of the fund. equipment in the hospital.
Nepal — — We follow the Public Working on to develop —
Procurement Act and the national inventories.
regulation of Nepal for
procurement of medical
devices also. Also, it is partially
carried out at national level
procurement of medical
devices.
Netherlands For vigilance and post As per regulation 2017/45 on There is the Commission The Netherlands has no —
market surveillance medical devices and Regulation decision of 7 May 2002 national inventory for medical
(more info in the (EU) 2017/746, the EU Member on common technical devices.
medische-hulpmiddelen States Competent Authorities of specifications for in vitro-
corresponding link). MD representatives (of both the diagnostic medical devices.
(EMDN)
A97

or reimbursement
New WPR Under New Zealand law there is no — — National Health Committee performs
Zealand approval system for medical devices HTA in several areas, but not for
and hence no pre-market scrutiny medical devices.
of their safety and performance.
There is a legal requirement for
the sponsor (importer/exporter/
supplier) of a medical device (with
some exceptions) to notify the
device to a database maintained
by Medsafe within 30 working days
of becoming the sponsor for the
device.
Nicaragua AMR — — The Ministry of Health does not There are identified HTA activities but
have lists recommending health not a national unit.
technology for different diseases or
situations.
Niger AFR — — — —
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specifications:
New — — National requirements apply — The definition of medical
Zealand only to procurement of electro- device used in NZ law
medical devices through a set (the Medicines Act 1981)
of AS/NZ standards such as is not currently aligned
AS/NZ3551:2004 which are with the GHTF approach.
mandated under a national Consequently, some
law. Government publishes products that are regarded
standards that are applicable to as devices in other countries
some devices. are currently regulated as
medicines in NZ. Examples
include pregnancy tests,
condoms with spermicide,
IUCDs with copper and nasal
irrigation solutions.
Nicaragua — For various reasons, there is not The procurement department This inventory was carried Our Ministry of Health
an official nomenclature system works as a team with the out for the maintenance unit is doing big efforts to
used for medical devices. Health Services Department, (CEMED). The last update was normalize and regulate the
the Sanitary Regulations in 2009. procurement of medical
Department and the Acquisition devices, but we do require
Unit of the Ministry of Health. training for our personnel
to perform a better job.
We also have limitations in
providing maintenance to
the acquired equipment.
Niger — Il ya plusieurs types de Toutes les acquisitions réalisées Il ya eu plusieurs tentatives Le Niger dispose d’une
codification testés. Les premières dans le cadre des projets et d'installation de logiciel stratégie nationale de
se sont inspirées du code CNEH programmes passent par la de GMAO (Gestion de la maintenance adoptée depuis
(code national pour l'équipement DIES. Mais certaines (ONG Maintenance Assistée par avril 2008.
hospitalier) français. Il n'ya pas et associations caritaives) ne Ordinateur) dont Gestmat (par
de codification unique retenue passent pas. la Société Deloitte et Touch
au niveau national. Consulting) et OPTIM (par
le Bureau BEEM Engineering
France). Aucun logiciel n'est
totalement fonctionnel en ce
moment.
A99

or reimbursement
Nigeria AFR — — — Three organisms perform HTA at
a national level: The Agency for
Food and Drugs Administration
and Control (NAFDAC),|Nigeria
Institute for Pharmaceutical Research
and Development (NIPRD) and
the National Health Insurance
Scheme.|(NHIS). The action plan
2018-2021 of the MoH states the
progress to a National Quality Review
& Health Technology Assessment
Systems to determine which health
interventions are cost effective
including medical devices (see fourth
link). HTA is a pliar for UHC's goal.
Niue WPR — — — —
North EUR The reimbursement is performed by — — There is not an HTA national unit yet
Macedonia the National Health Insurance Fund, per se but it has been acknowledged
the list of medical devices that are at a political level by the MoH. There
reimbursed are posted on the "fzo are HTA activities for the selection
website". In public health facilities of specific medicines. It exists a
the procurement is currently going Centralized System for external
through a public competition with price referencing and decentralized
those medical devices that have procurement prices of non-
entered the register of medical prescription medicines and devices.
devices.
Norway EUR A few devices - those being — — The system has two levels; a national
reimbursed via the blue prescription level where decisions based on
system i- are listed. Lists are made HTAs are made by the four regional
by The Norwegian Labour and health authorities in concert, and a
Welfare Administration, refer to the local/”hospital-level” where decisions
procurement of medical devices at are made based on the mini-HTAs
national level section. performed locally in each hospital.
Pharmaceutics have to pass always
by the national level. The Norwegian
Knowledge Centre for the Health
Services (member of the NIPH
since 2016) do HTAs on selected
procedures and devices upon
request.
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specifications:
Nigeria — — — — —
Niue — — — — —
North — The GMDN code is being — — —
Macedonia recognized.
Norway The Directorate of Health, The use of GMDN is not imposed Only procurement of devices — Concerning the HT national
Department of medical by law. being reimbursed via the blue policy, it was provided the
devices and medicinal prescription system is carried following document: plan
products is the Competent out at a national level, by The van aanpak patientveiligheid
Authority for medical Norwegian Labour and Welfare medische technologie.
devices in Norway, it has Administration. pdf.|Concerning the
the tasks of the competent infrastructure section: As of
authority as they are given 01.01.2009: 11 885 beds in
in the European directives specialised healthcare. 117
for medical devices. These of these are in the private
tasks, however, are not sector.
identical with those listed
under the corresponding
ones of this survey.
A101

or reimbursement
Oman EMR — — Medical devices for specific Drug control, bulk procurement and
procedures, whenever required, distribution of drugs are managed
are prepared or modified based on by MoH. There are identified HTA
the requirement from end users. activities but there is no national unit
Available at Directorate of Medical per se.
Technologies.
Pakistan EMR — — The provinces develop their lists —
of equipment based on their
health facilities, the available
funds, and according to the Priced
Vocabulary of Medical Stores
(PVMS) (Available). World Health
Organization Pakistan share such
lists with the Ministry of Health at
time of emergency.
Palau WPR — — — —
Panama AMR Available at the specified website. — — HTA activities are performed in the
MoH, Caja de Seguro Social (CSS),
and institutions such as the Instituto
Conmemorativo Gorgas de Estudios
de la Salud (1928) (GORGAS).
HTA is performed in several areas:
pharmaceutics, interventions, cost-
effectiveness, etc.
In the ministry of health, they perform
some kind of HTA processes for the
List of Essentials Medicines, in the
CONAMEP (Comisión Nacional de
Medicamentos de Panamá)
Papua New WPR — — — The 2011 initiative undertaken to
Guinea establish a national e-health strategic
framework and committee, as first
steps. There are identified HTA
activities but not national unit. The
Universal Health Care country goal is
in progress.
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specifications:
Oman — — The procurement guidelines are Available at the Directorate of —
available at the Directorate of Medical Technologies.
Medical Technologies.
Pakistan The WHO country team — The procurement service A national inventory was After the 18th amendment
helped the Ministry of rules 2003 (KPK) issued by previously maintained but now and devolution of the MoH,
Health in drafting rules the finance department. The is at a province/region level, it no person nor authority can
for regulations of medical procurement is carried out at is in pipeline. provide information, the
devices, but they are not a provincial level and identified WHO as convening body of
applicable after the 18th by SPRA etc. There is a health systems in Pakistan
amendment. National inventory for medical collected the information
equipment. separately from all regions/
provinces then the
information was compiled
by the WHO focal person of
health technologies.
Palau — — — — —
Panama — El sistema UMDNS ha sido La Caja de Seguro Social hace — —
adoptado en la legislación. Su sus procesos de adquisición
implementación está aún en de forma independiente del
proceso. Ministerio de Salud pero
sujeto al sistema de Fichas
Técnicas Nacionales en cuyas
confecciones también participa.
Papua New — — — — —
Guinea
A103

or reimbursement
Paraguay AMR — — — HTA activities identified, but not
proven at national or subnational
level.
Peru AMR — — There are National Standards or list Three institutions perform HTA:
of recommended medical devices Ministry of Health-DIGEMID; National
for specific procedures but it is Institute of Health (INS) and the
managed by protocolos of care Institute of Health Technology
at the Hospital, Health Center or Assessment and Research (IETSI-
Specialty Hospital. For a), b) and c) ESSALUD).
there are protocolos of care at level Besides this 3 institutions, there is
of hospitals. d) No. There aren´t one more: INEN-
. There are contingency plans at Instituto Nacional de Enfermedades
levels of hospitals. Public health Neoplásicas, that perform HTA too.
emergency situations (pandemic,
Moreover, in 2020, by Ministerial
acts of terrorism, natural disasters,
Resolution No. 190-2020, the National
contamination, etc.).
Network for Health Technology
Assessment (RENETSA) was formed,
made up of:
- INS
- DIGEMID
- The Social Health Insurance
(ESSALUD), through the Institute
for the Evaluation of Technologies in
Health and Research (IETSI)
The INS, through the CETS, will lead
the National Network for Health
Technology Assessment – RENETSA,
which brings together public entities
and academic institutions that carry
out health technology assessment in
the country.
Contact: INS Nora Reyes Puma
nreyes@ins.gob.pe
DIGEMID JENNER IVÁN
SOLIS RICRA isolis@minsa.gob.pe
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specifications:
Paraguay — Se está elaborando un plan para Procurement guidelines: — Concerning the HT national
proceder con la instalación de un se inició la elaboración de policy, it was provided
sistema de nomenclatura. directrices. the following document:
DECRETO EJECUTIVO 468.
pdf
Peru — Ley Nº29459-D.S and the D.S. Nº — There are any kind of —
016-2011-SA. inventories for medical devices
available in the country.
A105

or reimbursement
Philippines WPR The lists are limited to diagnostics, — This is part of the requirements for HTAC has one biomedical engineer
no interventional equipment noted the licensing of health facilities. The and one medical physicist.
(ie, ECMO, DaVinci, etc.) given URL is for general surgery.
The indicated website can be
browsed for other recommended
medical devices for other
procedures.
Poland EUR The polish competent authority for There are no lists, but basic There are no lists, but basic AOTMiT evaluates pharmaceutical
medical devices is the Office for (minimal) requirements regarding (minimal) requirements regarding and non-pharmaceutical technologies
Registration of Medicinal products, the necessary medical devices the necessary medical devices that including medical devices
Medical devices and Biocidal that are a part of the health are a part of the health benefit assessment. The Agency for Health
products, which keeps the register benefit package regulations package regulations and are Technology Assessment and Tariff
of medical devices in a database; it and are created concerning created concerning the type of System evaluates pharmaceutical and
is only used for market surveillance the type of facility (including facility (including specialisation) non-pharmaceutical technologies
and vigilance purposes. On polish specialisation) and with clear- and with clear-cut requirements on including medical devices
market can be placed all CE - cut requirements on specialised specialised health care services. assessment.
marked medical devices according health care services.
to current EU regulatory framework
and directives (90/385/EEC; 93/42/
EC; 98/79/EC).
Portugal EUR — — — Functions of Infarmed: Research,

assessment, registration, monitoring
and supervision of health products.
Clinical research evaluation,
assessment and registration of CE
marked medical devices, notification
of health care products and market
supervision activities.
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specifications:
Philippines — The Philippines will be using The procurement for a medical — —
the Nomenclature that will device is part of the National
be decided by the member Procurements system of the
states of the ASEAN who are Philippine Government (see
working on the harmonization website). Procurement of
of medical device regulation in medical devices can be done
the region, where medical device at a national level, at a regional
nomenclature is one of the level and local government
concerns. units.
Poland The Ministry of Health is As per regulation 2017/45 on — — —
the national regulatory medical devices and Regulation
authority in the area of (EU) 2017/746, the EU Member
the health system and States Competent Authorities of
The Office for registration MD representatives (of both the
of Medicinal Products, national MoH and the national
Medical Devices and agencies) of the MDCG, have
Biocidal Products is the opted for the publicly available,
polish competent authority accessible and transparent
responsible for cooperation nomenclature named European
with European Commission Medical Device Nomenclature
in the medical device (EMDN)
regulatory area. Another
regulatory agency is
the Market Surveillance,
Vigilance system, Clinical
trial registration and
Inspection, Cooperation
with the European
Commission and other
Competent Authorities.
Portugal — The Directorate-General of Go to the website and search — —
Health/Ministry of Health of this for the "contratoseaquisicoes"
country pointed out that the documents.
official nomenclature system for
medical devices and IVDs for
registry purposes is based on
the European Medical Device
Nomenclature (EMDN).
A107

or reimbursement
Qatar EMR There are functional inventory of — HMC disciplines occupies functional There are identified HTA activities.
medical devices for procurement inventory of medical devices for HTA consultancy is required for
and/ or reimbursement in HMC prompt delivery of patient care building high-level infrastructure
hospitals. HMC disciplines occupies services. It exists the emergency and there is the formation of an HTA
functional inventory of medical prepardness policy reference workforce but there is not a national
devices for prompt delivery of (including lists) too. unit. Drugs pricing falls on External
patient care services. Emergency Reference Pricing stated in the
prepardness policy reference. national objectives towards Universal
Health Care (UHC) implementation
goal.
Republic of WPR The Health Insurance and Review — — HTA is performed in a variety of
Korea Assessment (HIRA) is responsible health areas including medical
for listing treatment materials for technologies, devices, interventions,
public insurance. etc.
Republic of EUR A special group of Agency of — Medical standards on diagnostic There are identified HTA activities but
Moldova Medicines and Medical Devices and treatment for pathological not a national unit per se.
organise the procurement of conditions in surgery, therapeutic
medical equipment from the state profile for adults and children,
budget. have been developed. Also,
development of guidelines is based
on international recommendations
for family physicians and blood
transfusion agencies.
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specifications:
Qatar If ever a private agency, This is used for planning of The specification compliance Maintained GE AssetPlus for List of accredited HMC
hospital or clinic needs medical equipment for new / on safety and clinical requisites the functional inventory of hospitals: Hamad General
a specific product they upcoming projects. is regularly updated. The Medical equipment for the Hospital, Women's Hospital,
should approach the Hamad Medical Corporation Hamad Medical Corporation Rumailah Hospital, Al
Medical Licensing which (HMC) Materials Management (HMC), hospitals and Public Amal Hospital, and Al Khor
in turn seeks technical and Tender committee take Health Care Centers. Hospital. Emergency Medical
evaluation (such as over the procurement activities Services (EMS), Pediatric
specification, safety, of Medical and Non-Medical Emergency, Trauma Centers,
compliance, etc.) from the Equipment/ items for HMC Orthopedic Center, Dental
Bio-Medical Engineering hospitals, and the ministry upon and School Health, Home
to import the product to request, as deem necessary. Healthcare, Primary Health
the country. Bio-Eng does Specification of equipment Centers, Skilled Nursing
verify FDA, CE and/ or formulated in cooperation with Facility. Upcoming projects:
equivalent compliance end-user prepared by Bio-eng. Qatar Heart Center, New
on medical device/ Children's Hospital, Al-Wakra
equipment for safety, Hospital. Please visit the
especially for Hamad Hamad Medical Corporation
Medical Corporation (HMC) website (www.hamad.qa)
hospitals. and the Qatar Supreme
Council of Health website
(https://www.moph.gov.qa/)
for more details.
Republic of — — National and public hospitals The inventories for medical Concerning the
Korea purcharse medical equipments devices are not managed by Infrastructure section: Korea
according to the general the government. Health Center is down to 29
procurement procedures. beds.
Republic of The National Center of — Procurement guidelines: It is not developed. A project The strategy to develop
Moldova Public Health is ensuring Government Decree No. to support management of Health System during
the control of the rules 568 (10.09.09). Guidelines medical equipment is being the period 2005-2017 as
of utilization of X-Ray on technical specifications: developed: openMedis. well as the Plan of Action
equipment in all medical Decree 190 from 25.06.2009 contains specific goals on
institutions of the country. establishes standard strengthening the bases
specifications for biochemical of technical material for
and immunology test. healthcare.
A109

or reimbursement
Romania EUR — — — Several national entities are in charge
of performing HTA activities, each
one focus in various areas (see
corresponding links).
Russian EUR — — — The HTA system development is

Federation inserted in the Russian Federation
healthcare legislation. Currently,
the procedure for a comprehensive
assessment of drugs has been
approved and is constantly being
improved. However it is still at their
start phase for medical devices and
biomedical products.
Rwanda AFR — — — There are identified HTA activities
which are specifically done in
pharmaceutics for pricing and
reimbursements as well as health
economics; however, there is no
national unit.
Saint Kitts AMR — — — —

and Nevis
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specifications:
Romania — As per regulation 2017/45 on The procurement of high — —
medical devices and Regulation technologies devices is carried
(EU) 2017/746, the EU Member out at anational level. Go to
States Competent Authorities of the website and search for the
MD representatives (of both the corresponding documents.
(EMDN)
Russian — — — — —
Federation
Rwanda — Rwanda has started to use — — —

Online Public Procurement, each
device should have an unique
identification code (mainly based
on UMDNS). But it is challenging
when dealing with different
code nomenclature such as the
sterilizer, autoclave or medical
gases. Rwanda uses UMDNS for
inventory and maintenance of
medical equipment.
Saint Kitts — — Hospital management — —
and Nevis purchases devices directly from
vendors.
A111

or reimbursement
Saint Lucia AMR — — — —
Saint AMR — — — There are identified HTA activities but

Vincent not a national unit. The development
and the of one is in progress.
Grenadines
Samoa WPR — — Please refer to Biomedical There are identified HTA activities
Engineering Unit Head, Mr. Galuafi but not a national unit. MoH together
Vaoga at email: biomed@nhs.gov. with National Health Services (NHS)
ws. intend to develop one, but it is still on
progress.
San Marino EUR — — — There are identified HTA activities but
Sao Tome AFR — — Il n'existe pas au niveau national —

and Principe aucuen liste recomandant des
technologies de sante.
Saudi Arabia EMR — — Food and Drug Adminstration - The Ministry of Health supports the
Specification and Measurement creation of a national entity for HTA
Administration. in healthcare as part of the National
Transformation Program. The new
HTA entity will deal mainly with
pharmaceutics but is intended to
extends to other health products
such as devices. Informed HTA
decisions were rarely identified for
medical devices.
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specifications:
Saint Lucia There is the Bureau of — The procurement at a The medical equipment —
Standards which will do the national level is not for inventories of public hospitals
regulatory activities. medical equipment, but for exist. The functional status of
pharmaceuticals. such equipment is reflected in
these lists. No PET scanners
are available on the island. CT
and MRI are available only in
one private hospital facility.
Saint — — — No national inventory exists. —
Vincent
and the
Grenadines
Samoa — — For more information refer to — Concerning the
the Biomed Engineering Unit. Infrastructure section: there
are 18 General Practicioner
Clinics in the Private sector.
San Marino — — — — For specialized care and

diagnostics, patients can be
treated in italian hospitals
that have agreements with
San Marino.
Sao Tome — — — L'inventaire des equipments —
and Principe medicaux existant est
caduque (2002) Apres cette
date un nombre considerable
des equipaments ont rentres
en charge.
Saudi Arabia — A committee inside NUPCO National Unified Procurement For every hospital and Concerning the HT national
has been established for that Company for Medical Supplies health centre there is a policy it is stated on the
purpose and the work is in (NUPCO). maintenance-specialized Medical Egypt Management
progress. company contracted to make Plan (Corporate).
the inventory and perform
necessary maintenance
activities for all medical
devices within the facility.
Also, there is a National
inventory for high cost
technologies (such as MRI, CT
or PET scanners).
A113

or reimbursement
Senegal AFR — — Il existe une liste standard de base —
pour toutes les structures sanitaires.
Pour la plupart des acquisitions,
les specifications techniques des
équipements sont réalisées par
la Direction des Equipements et
de la Maintenance. Voir aussi les
spécifications techniques des
équipements médicaux.
Serbia EUR Not available at the moment. — There are no specific national It conducts centralized public
standards nor recommended procurement for health products
medical devices for specific including devices. HTA is in the law
procedures. And there are no lists and with a centralized national unit
recommending health techology for either MoH sector for inspection
different diseases/situations. affairs or Public Health Institute (NIS).
Seychelles AFR — — — —
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specifications:
Senegal — — On procéde à des appels On a une inventaire national —
d'offres nationaux et les des équipements médicaux
representants des fabricants (2009).
etrangers fournissent les
équipements.
Serbia — National nomenclature is in Go to the website and The inventory was made, The Institute of Public Health
the process of updating and search for the corresponding in 2000, according to of Serbia has a department
amendment. documents. methodology. In 2003, for health technology
European Agency for assessment mainly
Reconstruction commissioned responsible for updating
a project performed by IPH nomenclature and type of
Serbia, but the methodology technology.
was not included in the
national Law on Health
Records and Statistics and
has not been adopted, so
the inventory continued to
be performed on annual
basis based on the existing
Law on Health Records and
classification of medical
equipment (1980's). The
inventory is not available.
Seychelles — — "It is a small committee that " —
meets to discuss equipment
request by the various units
within the Ministry of Health.
Please note that Seychelles has
a small population and we do
not purchase equipment on a
big scale.
A115

or reimbursement
Sierra Leone AFR Lists for procurements are still — — —
being worked on not yet completed.
However we do have public health
emergency situations lists.
Singapore WPR A list is available in the form of the — — —

Singapore Medical Device Register
(SMDR). This shows all approved
medical devices in Singapore and
provides information on them. It is
not a list of recommended devices
for procurement.
Slovakia EUR — — There is no list recomending health The Working Group for
technology for above mentioned Pharmacoeconomics, Clinical
diseases/situations. Outcomes and Health Technology
Assessment of the Slovak Ministry
of Health perform HTA, but not
specifically for medical devices.
Slovenia EUR — — There are many boards (Slovenian HTA framework is not done yet, but
Collegiate Boards) each responsible HTA processes are in an existing
for one area of medicine. Those framework. HTA decision-taking is
bodies produce recommendations done by the following institutions:
on specific procedures where MoH, National Institute of Public
deemed necessary. Currently, Health, and the Agency for Medicinal
recommendations are under Products and Medical Devices of the
development at the Ministry of Republic of Slovenia (JAZMP).
Health.
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specifications:
Sierra Leone — The document is not available for Most of the equipment The last inventory was done There is a limited number of
the Facilities and Maintenance has been used and found twelve years ago. Looking technical personnel to meet
Unit. incomplete, and this is the forward to start another one. the service demand. Most of
reason why its installation the equipment supplied by
is difficult. Procurement of donors are obsolete and out
medical devices is carried of order.
out without involving the
specialists.
Singapore — The Global Medical Device — — —
Nomenclature (GMDN) is used
as an internal reference and it is
not required for medical device
product registration
Slovakia — As per regulation 2017/45 on — — —

(EMDN)
Slovenia — As per regulation 2017/45 on The name of the procurement The inventories website is still —
medical devices and Regulation policy is: Zakon o javnem in development and is not yet
(EU) 2017/746, the EU Member naročanj (ZJN-3) available to the public.
(EMDN)
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or reimbursement
Solomon WPR — — Unfortunately, there are no such There is no formalized HTA available
Islands lists. Donation equipment have and it relies heavily on other
various brands. institutions assessment mechanisms,
such as the WHO.
Somalia EMR — — — National Medicines Regulatory

Authority (NMRA) under Department
of Medical Services has an HTA role.
However, even if the designated unit
is present in the organigram is not
yet well established. There are scarce
HTA activities, but the plans are to
expand, specially in pharmaceutics.
The UHC country goal is in progress.
South Africa AFR There are no lists of the mentioned Both UMNDS and GMDN have There are none of the cited lists The institutionalization of a national
above. The list is only for the been used. mentioned above. HTA as part of the ongoing
private sector funders (not National Health Insurance (NHI) is
the government). The National in the process towards the National
Department of Health is engaging Department of Health (NDoH) and
with the private sector to establish a the Universal Health Care (UHC) goal.
national system.
South Sudan AFR — — — —

Spain EUR — — — There is a network of Agencies for
HTA and services of the National
Health System. The HTA is for
decision-making within the health
system, as well as for medical
products, including medical devices.
Sri Lanka SEAR — — — The institutionalizing of an HTA as

a mechanism for promoting health
system integrity is in early stages.
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specifications:
Solomon The National Referral There is virtually none of this The procurement Unit, Ministry — —
Islands Hospital (NHR) performs currently in place. of Health & Medical Service, has
most of the procurement, mainly to do with the finance
planning and allocation but no with the technical
for the Provincial Hospital. aspect of the equipment. The
There is a disposable Committee is Ad hoc and meets
procurement by the only to allocate equipment base
Ministry of Finance. on Departmental requests.
Somalia — The definition of medical devices — — —
is included in the national
medicines law which is not yet
ratified.
South Africa The radiation control is The regulator has adopted The Office of the Chief There are no national —
now part of the tasks of the use of GMDN which will Procurement Officer is in inventory nor management
the South African Health be a nationally accepted charge of the procurement of systems but some hospitals
Products Regulatory nomenclature. medical devices. do have. Currently, we are
Authority (SAHPRA). compiling a national inventory
and acquiring a system to be
implemented at a national
level. Thus, we are progressing
to acquire the national system.
South Sudan — — — — —
Spain — As per regulation 2017/45 on — — —
(EMDN)
Sri Lanka — — — — —
A119

or reimbursement
Sudan EMR — — — A Health Technology Management
system (HTM) has been developed.
However, there is not current HTA
system in place, but it is a goal to
pursue towards the Universal Health
Care country goal.
Suriname AMR — — — —
Sweden EUR The devices must bear the CE-mark. — There is an ongoing project in order Network of HTA agencies such as: the
to create such a national list. It is Dental and Pharmaceutical Benefits
the Dental and Pharmaceutical Agency (TLV); Agency for the HTA
Benefits Agency that is working and Assessment of Social Services
with that. (SBU), and Medical Products Agency.
Alternative email: registrator@tlv.se.
Switzerland EUR Reimbursement list for medical — — There is the swiss network of HTA
devices used by the patients entities focusing in various areas.
themselves, and Reimbursement list Some institutions are: Health
for medical analyses are available Insurance Benefits, State Secretariat
on the corresponding website (see for Education, Research and
link). Innovation, etc.
Syrian Arab EMR — — — It exists the Planning and

Republic International Collaboration
Directorate which performed HTA
activities, but it is not specifically for
medical devices.
Tajikistan EUR — — — —
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specifications:
Sudan — — — — —
Suriname — — — — —
Sweden — As per regulation 2017/45 on The national law for — —
medical devices and Regulation procurement is based on
(EU) 2017/746, the EU Member the EU directive. Concerning
States Competent Authorities of procurement, it can be done
MD representatives (of both the at a country level or within a
national MoH and the national single hospital.
(EMDN)
Switzerland — Swissmedic uses GMDN (no The medical devices must fulfil Go to the gdk website and —
country specific nomenclature), the requirements described search for the 291.0.html
if manufacturers do not know the in the European medical documentation.
GMDN number, a UMDNS code device directives. Legal
may be given. basis (Swiss Medical devices
ordinance):|http://www.admin.
ch/ch/d/sr/c812_213.html. The
hospital / high cost technology
planning is done at a national
level. Coordinated planning of
certain highly specialized areas
of health care is in progress
(see|https://www.gdk-cds.ch/
de/).
Syrian Arab — — — — —
Republic
Tajikistan — — — — —
A121

or reimbursement
Thailand SEAR There are lists of recommended — There are lists of recommended HTA is focused on several health
procedures in organization level procedures in organization level technologies and programs, including
such as the procedure of the such as the procedure of the pharmaceuticals, medical devices,
Physical Therapy Council. The Physical Therapy Council. interventions, and disease prevention
approved medical devices list is only as well as to inform policy decisions.
available for the reimbursements
of the three health insurances,
namely the National Health Security
Office, the Comptroller General’s
Department, and the Social Security
Office.
Timor-Leste SEAR — — There is the Standart Medical —

Equipment from Australia Advissor
of Medical Equipment. See
Clasification Minimum Standard
equipment HP, CHC, DHC.
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specifications:
Thailand The Office of Atoms — The procurement was — —
for Peace (OAP), within performed by individividual
the Ministry of Science agencies. For technical
and Technology, is the specifications go to the web
responsible agency for site and find the law section,
strengthening regulatory search for the corresponding
control of sources that documents.
involve radioactive
activities such as
manufacturing, radiation
processing, radiation
application (medical,
industrial, research,
etc.), importation and
exportation of radioactive
sources and radioactive
waste management under
the Atomic Energy for
Peace Law, BE2504 (1961)
and the Nuclear Energy
for Peace Law, BE 2559. It
also guarantees the safety
of users and the public
against radiation and
nuclear use by regulating
the use of nuclear energy
and by educating the
public.
Timor-Leste — — — The Inventory is from 2002- The Health Technology of
2009. medical equipment does not
have standards for Medical
Equipment yet.
A123
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or reimbursement
Togo AFR Aucune organisation en charge — — —
de ces listes existe, malgré toutes
les propositions formulées dans
ce sens. Il ne semble pas avoir la
volonté politique à évoluer dans ce
sens.
Tonga WPR — — There are no specific lists. —
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specifications:
Togo — Le niveau du sous service chargé La politique suivi en terme Bien que cela soit le point Compte tenue des difficultés
chargé des équipements est d'achat de dispositif est celle du de départ de toute gestion que nous rencontrons pour
trop bas pour être lisible. Les code des marchés publiques. en terme de maintenance la prise en compte adéquate
supérieurs hiérarchique ne L'achat ne se fait au niveau des parcs biomédicaux, des plateaux techniques
portent pas l'intérêt nécessaire central que si l'Etat définit cette opération n'existe pas dans nos formations
pour la mise en oeuvre de la ponctuellement un programme au plan national sauf par sanitaires malgré les
gestion qui s'impose pour les d'intervention suite à une endroit mais aussi de façon recommandations régionales
dispositifs médicaux. urgence nationale. sommaire . Les données ainsi pour une politique commune
consignées ne permettent pas en matière de maintenance
de l'exploiter pour proposer et la gestion durable des
des plans de renouvellement infrastructures sociales
ou de developpement de je veux bien croire que
parcs biomédicaux. En bref cette enquète nous ouvrira
aucun inventaire digne de ce l' horizon de nouvelles
nom n'existe pas sur le plan politiques adptées à nos
national. réalités.
Tonga Although there is no formal — — — —
institution that oversees
the implementation of any
medical device regulation,
there is the "Facility and
Equipment Committee" of
the Ministry of Health that
oversees certain things
such as the procurement
of medical devices, the
criteria of acceptance of
donated equipment and
the implementation of
maintenance guidelines,
etc.
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or reimbursement
Trinidad and AMR The nomenclature is part of Certification standards for The list exists for point of care There are identified HTA activities
Tobago the Computerized Maintenance equipment, e.g. European CE testing equipment, namely, at a national level. Furthermore
Management System. Marking and U.S. Food and Drug Diagnostic Screening and a consultant is to be engaged to
Administration. Laboratory Testing. The medical assists in the development of an HTA
equipment requirements for framework. Alternative contact for
specific procedures are done by the Health Technology Management
the respective inhouse Hospital unit: pmu@health.gov.tt.
Biomedical Department and the
clinicians. The American Hospital
Association guidelines are used
as a reference. Also, the Ministry
has established requirements for
Diagnostic Laboratory Point of Care
Testing.
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specifications:
Trinidad and — Developed and in use as "Fixed There are guidelines based on The inventories of other It is noted that several
Tobago Assest Inventory and Facilities the Regional Health Authorities medical devices exist at each medical devices systems
Management". TMA Systems (RHAs) internal policies and respective Regional Health exist at the respective
Maintenance Management procedures on the procurement Authorities (RHA) and for Regional Health Authorities
Software (the nomenclature of process and in particular for high-cost technologies such as (RHA) level. The MoH is
medical devices are generally the need of the development diagnostic imaging. currently working towards
developed by the respective of specifications. The Ministry standardising these and in
Regional Health Authorities for of Health is presently moving particular concerning the
procurement purposes). The towards standardising policies procurement guidelines for
Ministry of Health of Trinidad and and procedures for all technical medical devices.
Tobago has established that no areas which would include
specific or official nomenclature the procurement of medical
system is used in this country, devices. Technical specifications
but the nomenclature codes are developed as part of all
given by manufacturers equipment procurement for
public open tender. In general,
there are recommended
technical specifications used
by each RHA for procurement
of equipment as part of public
tendering requirements. This
is an area that the ministry is
working with the RHAs towards
standardising. For procurement
information contact via mail
to pmu@health.gov.tt (Project
Management Unit).
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or reimbursement
Tunisia EMR L'acquisition et la mise en service — L'acquisition et la mise en service INEAS is under the auspices of the
des equipements lourds sont soumis des equipements lourds sont MoH. It evaluates health technologies
a l'autorisation préalable du MoH soumis a l'autorisation préalable and provide rigorous evidence-based
pour les secteurs publique et privé du Ministère de la santé publique recommendations to decision-
et ce conformément aux critères pour les secteurs publique et privé makers on pharmaceuticals and other
et normes fixés par les arrêtés sus- et ce conformément aux critères technologies' uptake and use. As one
indiqués. -Arrêté. Dune manière et normes fixés par les arrêtés sus- internal policy trains it' s own staff, as
générale la liste de matériel découle indiqués.-Arrêtés du 22/6/2000 well as HTA user's.
de l'activité préconisée sans liste et du 7/3/2003. Dune manière
préetaéblie. Seules les produits générale la liste de matériel découle
non conformes aux spécifications de l'activité préconisée sans liste
techniques fixés par les cahiers de préetaéblie.
charges (CCTP) des appels d'offres
ou dont le contrôle technique à
l'importation non concluant et ceux
qui ne sont pas autorisés a être
mis sur le marché dans leurs pays
d'origine ne sont pas autorisés a
etre mis sur le marché Tunisien.
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specifications:
Tunisia — La nomenclature des dispositifs L'achat des dispositifs Conformément au manuel La structure publique
médicaux fait partie intégrante médicaux obéit en plus des des procédures de gestion de santé en Tunisie est
du Manuel des procédures procédures réglementaires de la maintenance chaque composé de établissements
de gestion de la maintenance (Reglément des marchés établissement de santé est publics de santé (CHU,H.
biomédicale et hospitalière publics) d'unepart et passe par dans l'obligation de tenir Spécialisés) dans les sièges
élaboré en 1996 et amélioré en des commissions techniques un inventaire technique de faculté de médecine des
2007 par le Ministère de la santé spécialisés (commissions des équipements et des hôpitaux régionaux des
publique qui a fait l'objet d'un d'elaboration des cahiers des infrastructures techniques, hôpitaux de circonscription
arrêté. clauses techniques particulieres, remplir la fiche d'identification des groupements de santé
fiches techniques, commissions et une fiche de santé de base des centres de
de sélection, des commissions (maintenance) par appareil. santé de base et des centres
de réception provisoire et Un applicatif informatique régionaux de médecine
définitifs du matériel fiches dédiée a été développé à cet scolaire et universitaire
techniques). Il n'ya pas de effet. Management Software: en plus des trois hôpitaux
fiches techniques standard G.M.B.H. développé en local militaires et un hôpital des
mais elles sont préparés par le cetembh et le centre forces de sécurité intérieure
au cas par cas en fonction informatique du msp. publics et six centres
du besoin (caractéristiques de d'hémodialyse et six
opérationnelles). polycliniques para-publique
ne relevant pas du ministère
de la santé le secteur
privé compte 3371 unités
réparties entre cliniques,
cabinets dentaires, officines,
cabinets de radiologie,
centres d'imagerie médicale
laboratoires et centres
d’hémodialyse.
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or reimbursement
Türkiye EUR The Ministry of Health is closely — These standards are not centrally Generic email of the HTA department
involved in the decision making organized and published. Each shgm.argestd@saglik.gov.tr .
but the main responsible unit is the department has its own and they
Social Security Institution of the can be found in the second link
Republic of Turkey. The directorate under Saglik Mevzuati>Genelgeler,
of Curative Services is the main Tebligler, Yönergeler,
responsible unit in the Ministry of Yönetmelikler>… Relevant
Health but other directorates also departments and headlines. Each
give their opinion on the subject. directorate and department has
There is the new version (2010) of its relevant health technology
the relevant document. Specific lists reference documents (guidelines,
can be reached by opening EKLER circulars, regulatory statute etc) in
Appendix (see in website). its links on the website.
Turkmeni- EUR — — — There is no systematic programme of

stan health technology assessment, but
an informed decision is mainly used
for pharmaceutics but no for medical
devices.
Tuvalu WPR — — — National Drug and Therapeutic
Committee (NDTC) has done HTA
activities mainly in pharmaceutics;
however, there is no a national HTA
unit.
Uganda AFR Usually we use the WHO Standard Medical Equipment list There are no national lists There are identified HTA activities but
recommendations. List of is under review. recommending health technology there is not a national unit.
equipment by health care level is for specific procedures. We
available in the website. usually adhere to the World Health
Organization recommendations.
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specifications:
Türkiye — Huab is the Turkish registry — Go to the previous website Concerning the medical
system for medical devices. Both and search for sbhbt. However, equipment and structure
GMDN and UNSPSC are used in the full online inventory section: there is a draft
this system. For reimbursement databank, with restricted document (Health Statistics
purposes another nomenclature use to the authorities, is on Yearbook) at the link:|https://
mentioned in the corresponding the following site:|http://sbu. hsgm.saglik.gov.tr/tr/ , but
link is also used. saglik.gov.tr/sbhbf/ it is not appropiate to use
it as a reference since the
original document will be
available in the future. Some
numbers can be variable
because of the dynamic
situation in Turkey. Especially
for the last 5-7 years, the
health technology situation
is changing and developing
rapidly.
Turkmeni- — — — — —
stan
Tuvalu — — Guidelines on Donations exist, — —

they are nationally developed
but they are not publicly
available.
Uganda — See the list of medical equipment The Ministry acquires resources Currently, is being updated. The policy guidelines on
by level, and the Standard and procures in bulk; although donations is at Chapter 5.1.5
Medical Equipment Lists and for the last 2 years development of the medical equipment
Specifications by healthcare level funds for infrastructure have policy (see documentations).
are under review (as in sample been directly allocated to The Medical Equipment
formats in the corresponding regional referral hospitals Policy is under review.
websites). The main uses of which procure equipment with
the nomenclature system are the guidance of the health
for procurement purposes, and infrastructure division and
inventory systems in healthcare national advisory committee on
facilities. medical equipment (NACME).
The Public Procurement and
Disposal of Public Assets
Authority (within the MoH,
specified website).
A131

or reimbursement
Ukraine EUR — — There are many files, namely, the In 2019 was established the national
orders MSS. Orders of the Ministry HTA within the MoH to power the
of Health approval of protocols of National Essential Medicines List
care for various diseases. and to inform the National Benefits
Package towards the Universal
Health Care. The HTA is focused on
a wide range of health products,
interventions, but till now is rarely
focused in medical devices.
United Arab EMR — — — HTA activities have been identified
Emirates within the MoH. It exists the Health
Authority Abu Dhabi, the Dubai
Health Authority and the Department
of Health (DoH) but there is not a
national unit. The main activities
of the HTA are in health products
pricing and reimbursement decisions.
Also, the private sector is playing
an increasing role in health care
coverage.
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specifications:
Ukraine — — Contact: Mr Ivan Zadvornykh, — —
Email: ivanzadvornykh@gmail.
com
United Arab — — — — —
Emirates
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or reimbursement
United EUR There is no approved list of medical — The Centre for Evidence Based Evidence-based recommendations
Kingdom devices for procurement. However Purchasing (CEP) website is a portal are developed in a wide range of
of Great we have lists for communicable and containing over 600 and therefore areas: clinical guidelines, diagnostic
Britain and non communicable diseases, and too numerous for specific reference technologies, interventional
Northern public health emergency situations. in this document. Please note CEP procedures, cost effectiveness, highly
Ireland Guidance is produced by NICE and was disbanded end of March 2010 specialised, and medical technologies
CEP which was disbanded 31 March but the reports still apply to clinical guidance.
2010. NHS Supply Chain provides a professionals UK wide. Also, NICE
catalogue of products that can be Interventional Procedures (IP)
purchased by the NHS which are Programme develops guidance
approved by way of meeting EU on interventional (mainly surgical)
directives. procedures, and approx two-thirds
of these involve a medical device
or devices developed specifically
for the procedure (see second
link). In addition to the IP guidance
referenced the previous lists,
NICE has produced guidance on
use of devices in the following
non-communicable high burden
diseases: ICDs, drug-eluting stents,
endovascular stent grafts for AAA,
inhaler devices for asthma and
insulin pumps (see third link). The
website is a portal containing the
full set of reports most of which
will be relevant to either a, b, or c.
They are too numerous to mention
here please also see comments of
previous lists.
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specifications:
United The Medicines and The Medicines and Healthcare Medical devices may be A recent amendment of the Concerning the HT national
Kingdom Healthcare products products Regulatory Agency procured at a number of Medical Devices Directive policy, it was provided the
of Great Regulatory Agency (MHRA) will be moving forward levels, either locally (NHS Trust has lifted the confidentiality following document:|http://
Britain and (MHRA) are the UK to use solely the GMDN with level), regionally (collaborative requirement on information www.president.gov.ua/
Northern Competent Authority their system being phased out. procurement hub level) supplied by manufacturers to docs/Programa_reform_
Ireland with respect to the safety, The nomenclature used by the or nationally (NHS Supply Competent Authorities under FINAL_1.pdf; www.rada.
quality and performance National Health System (NHS) chain). Also in Scotland, their obligation to register gov.ua. The UK comprises
placed on the market by for the procurement of medical there is a system for National certain types of medical 4 devolved administrations:
manufacturers in the UK devices is that used by the Procurement for the NHS. devices. The devices include England, Wales, Northern
under the EU Medical “Official Journal of the European low-risk class I, devices CE Ireland and Scotland. Each
Devices Directives. Trading Union” (OJEU) CPV codes. The marked based on a self- Administration is responsible
Standards Departments NHS also has a national system declaration of conformity by for the delivery of its own
based in local authorities known as “e-class” which is a the manufacturer, custom- healthcare system as well as
also have enforcement classification system for products made devices made according collating and maintaining its
responsibility in respect of and services. to a prescription from a own data. Therefore, there
medical devices available healthcare professional is no centrally held data that
over the counter direct to for an individual patient, covers the whole of the UK.
the public. assembled procedure packs, A range of initiatives around
re-usable sterile devices and the more widespread use of
in vitro diagnostic devices. clinically and cost-effective
EU member states including medical devices is underway.
the UK are currently working The work is in early stages
on how these registers can but once fully operational
be published. Higher risk should improve patients'
devices are CE marked based access to the latest health
on a conformity assessment technologies.
conducted by a third party
certification organisation
designated as competent to
undertake this function by an
EU member state. CE marking
denotes that the device
meets safety, quality and
performance requirements
accepted across Europe and
allows access to member
states markets without further
restrictions. In addition, there
also two national implant
registries in operation. One
for hip and knee implants
covering England &Wales.
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or reimbursement
UK cont...
United AFR Lists recommending health — Lists recommending health The institutionalizing of HTA for
Republic of techonology for different categories techonology for different categories decision making and priority setting
Tanzania of diseases is not available. The of diseases are not available. for guidelines, essential medicines
Ministry is however planning to However, the Ministry is planning to list, and cost-effective treatments
develop it. Registration of medical develop it. is in progress. The Tanzania HTA
devices in Tanzania has started committee (THTAC) is essential in
in January 2010. Registration will the progress towards the Universal
be carried out phasewise and 1st Health Care country goal.
phase involves single use devices.
The first phase involves limited
number of devices in particular
single use devices. Prior to the
start of first phase of registration
applicants were requested to notify
they are dealing with and the list of
notified devices is used as a basis
for approval during the transition
period. The guideline for registration
can be accessed at the tfda website.
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specifications:
UK cont... The other for pacemakers
for the whole of the UK.
Both record information on
individual devices, who they
were implanted in and when
both the original implant and
any revision procedure were
undertaken. Both Registries
produce annual reports which
contain all this data apart
of course from individual
patients names and other
personal details.
United — TMDA is using GMDN as the Medical Store Department — —
Republic of nomenclature system for the (MSD) is responsible for
Tanzania registration of medical devices procuring pharmaceuticals
in Tanzania. The main types of and medical devices for
nomenclature used are GMDN the public but not for profit
and UMDNS. The main uses of organization. It should also be
the nomenclature system are noted that individual entities
for procurement purposes and can also procure medical
inventory systems in healthcare devices on their own as not all
facilities. devices are covered by MSD.
The private sector imports
medical devices after obtaining
approval from TFDA. The
list of recommendations is
not available. However, the
guidelines for registration
recommend the use of ISO
standards and national
standards if available.
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or reimbursement
United AMR — — — There is not a single body nor a
States of national institution to evaluate health
America technologies. However, there is an
extensive network of HTA institutions
such as the Advisory Committee
on Immunization Practices (ACIP),
the Preventive Services Task Force
(USPSTF), the Medicare Evidence
Development & Coverage Advisory
Committee (MedCAC), the Agency
for Healthcare Research and Quality
(AHRQ), etc.
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specifications:
United — 1. Product Code. FDA- The — — Unfortunately, we are only
States of Center for Devices and able to respond to numeric
America Radiological Health (CDRH) uses country statistics. As is often
a nomenclature by assigning the case, they are too much
a 3-letter code to identify a difficulty for Federal States
device into a generic type or to answer; furthermore,
category. This nomenclature is largely irrelevant for a
system is known as product system like ours that is so
code classification. The short based on private sector.
name is ProCode.The Product
Code Classification Database
contains medical device names
and associated information
developed by the CDRH in
support of its mission. This
database contains device names
and their associated product
codes. The name and product
code identify the generic
category of a device for the FDA.
The Product Code assigned to a
device is based upon the medical
device product classification
designated under 21 Code of
Federal Regulations (CFR) Parts
862-892.2. Problem code FDA-
CDRH also has a nomenclature
for CDRH Event Problem Codes
for Medical Devices used in
reporting adverse device events.
The adverse event vocabulary
codes were developed in
cooperation with the National
Cancer Institute Enterprise
Vocabulary Service (NCI-EVS);
see the second link.
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or reimbursement
Uruguay AMR Las listas aún no se encuentran — — HTA is performed by the department
disponibles públicamente. of Health Assessment (MOH), and
the National Resources Fund (FNR)
in several areas concerning health
products, and healthcare, including
medical devices.
Uzbekistan EUR — — — HTA activities are carried out mainly

by the MoH, and the Evidence-
Based Medicine Centre within the
Tashkent Institute for Advanced
Medical Education. HTA is done for
various health topics: pharmaceutics,
medical devices, and also the
in pharmaceutics field but not
specifically for medical devices,
guidelines, etc. However, a national
HTA is still in progress as well as
unified national mechanisms for
developing and implementing clinical
standards, guidelines and protocols.
Vanuatu WPR — — This list exists as part of another —
document -e.g. essential drug list
or an inventory list of a health
facility- but there is no separate nor
specific document of the guideline
on its own. No list exists for any
of the conditions above (different
diseases/situations).
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specifications:
Uruguay — — Adquisiciones: Artículo 6º Realizado en 2008 y —
de la Ley Nº18211 Sistema actualizado en 2010 para
Nacional Integrado de Salud. Tomógrafos y Equipos de
UCA: Un mecanismo para los Resonancia Magnética. El
prestadores públicos; COCEMI: detalle de la información
Un mecanismo para algunos individual aún no se encuentra
prestadores privados. disponible en formato
electrónico.
Uzbekistan — — — — —
Vanuatu — When there is a plan to procure — An updated complete list of Vanuatu is a small island
a medical device, only then is the medical equipment does not country in the Pacific region
technical nomenclature required. exist at national level; but with a population of less
at subnational levels and at than 350,000: this explains
facility level, health managers the low level of health
maintain their own inventory facilities available.
for various commodities
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or reimbursement
Venezuela AMR — — — Las actividades de evaluación
(Bolivarian de tecnologías médicas se han
Republic of) desarrollado en el marco de la
Comisión Nacional de Evaluación
de Tecnología en Salud (CONETS)
dentro del Ministerio del Poder
Popular de la Salud.
Viet Nam WPR — — There are for all general procedures The HTA system has been developed
but they are not complete. We have by establishing nodal agencies
enacted medical device list for within MoH, moving towards the
procedures which shall be covered Universal Health Care country goal.
by medical insurance only. Priority-setting mechanisms and HTA
processes are at a nascent stage. HTA
is rarely applied to medical devices.
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specifications:
Venezuela — Does not have one specific Funindes (Univ. Simon — The most important
(Bolivarian nomenclature. For the Bolivar) is authorized by problems of the hospitals
Republic of) certification of the medical the Autonomous Service of in Venezuela were: the
device, the nomenclature the Sanitary Comptroller to electrical system, the air
used is the U.S FDA product carry out equipment analysis conditioning and the vertical
classification. for subsequent sanitary system (for 2001). In 2019
registration. the most serious problems
were water, sanitation and
hygiene: 79% of hospitals
reported failures in the
drinking water service;
most had the service
intermittently, only two or
three days a week. By 2011
there were 1,366 intensive
care units. By 2019 there
were 36 intensive care beds
in Venezuela. Currently, MRI,
CT, and Gamma Camera
specialized service is not
performed in Venezuelan
hospitals. |We as Funindes
USB are authorized by
the Autonomous Service
of the Sanitary Controller,
it is authorized to carry
out equipment analysis
for subsequent sanitary
registration: see Paper
Quality Certification of
Medical Devices in Venezuela
(https://globalce.org/index.
php/GlobalCE/article/
view/83).
Viet Nam Contact person: Hoang — — — —
Mai Bui - Director of the
Department of medical
equipment verification and
calibration.
A143

or reimbursement
Yemen EMR — — There is a need of financial, —
technical support and cooperation
to put national standards or lists of
recommended medical devices for
specific procedures. For different
diseases/situations there are
no existing lists; MOPH must do
that by cooperation of specialist
administrations.
Zambia AFR The MoH has developed the — — Evidence-informed healthcare

Standard Equipment Lists (SEL) priority setting via HTA is at early
for District facilities such as Health stages. Currently, HTA is being used
Posts, Health Centres and Level by the MoH to build the Health
One Hospitals). The SEL are not yet Benefits Package.
done, because the Basic Health Care
Package, which is the blueprint for
health service delivery in Zambia,
has neither been developed.
Zimbabwe AFR — — — It has been started the building

capacity and the HTA will be a
fundamental tool to achieve the
Universal Health Care goal.
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specifications:
Yemen There are Authorities — There are many procurements The MOPH is working in its There was a deficiency about
only for the registration carried out at a national level action plan state to complete maintenance and calibrations
of agents for medical but non-uniform standards by the database for medical of medical devices.
equipment. the health Governorate Office, equipment. In the case of
local governorates authority, some hospitals, the inventory
general hospitals authority, is done directly by them.
police health service, and army
health service; and there are
procurements carried out at
a national level like Unicef,
UNFPA, Emro, etc.
Zambia — — This is in reference to the The national data bank for The WHO used to run
guidelines on procurement, equipment is in its infancy; training programs for
donations, replacement of the data was collected three maintenance technicians
equipment at end of the years ago during a project but stopped long ago,
lifespan. The Ministry of Health that was funded by the Japan this has affected this field.
procures, under Mandate from International Cooperation There is a need for the
ZPPA; the Ministry of Health Agency (JICA). Currently, WHO to come in strongly
develops the list, quantities this data will be upgraded in support of maintenance
and specifications. Public this year. The information of Medical equipment. The
Procurement Authority sets the captured includes Equipment main problems in developing
framework for the procurement Description, Model, Maker, countries are lack of skilled
mostly International Serial Number, Location, manpower, inadequate
Competetive Bidding. These Functional Status, Age of budgets for maintenance,
are provided by the Medical Equipment. There are however lack of proper maintenance
equipment Unit but the hard copies at the facility level facilities equipped with
developed SEL for the District which maintenance units use. tools, test and calibration
facilities have specifications This needs to be computerised equipment, lack of
as well which are part of the and accessible from anywhere supportive policies. Coupled
planning documents used by which is not the case now. with a lack of local agents
the facilities for planning. There is no software for for the supply of equipment
equipment management but the traders take advantage
have tried ECRI and another and dump equipment which
software developed by a tomorrow will need services.|
professional in Holland.
Zimbabwe — — — — The country health
technology policy document
was initiated in 2007 with
funding from the US. This is
currently being formulated
into a policy document for
diagnostic imaging and
medical devices.
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Annex 2
Overview of nomenclature
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Contents - Annex 2
Annex 2. Overview of nomenclature systems for medical devices in WHO member states
Analysis of the Nomenclature Systems .. .. .. .. .. .. .. .. .. .. B5
Desk Review .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. B7
Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B7
World Health Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B7
International and regional agreements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B8
Comparison of desk review (2021) versus the Country survey (2020) and Nomenclature consultations
(2021-2022) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B10
Findings by country .. .. .. .. .. .. .. .. .. .. .. .. .. B12
Albania - - - - B13 Czechia - - - - B21 Iraq - - - - - B29

Angola - - - - B13 Denmark - - - - B21 Ireland - - - - B29
Argentina - - - - B13 Djibouti - - - - B21 Israel - - - - B30
Armenia - - - - B14 Dominica - - - - B21 Italy - - - - - B30
Australia - - - - B14 Dominican Republic - - B22 Jamaica - - - - B31
Austria - - - - B14 Ecuador - - - - B22 Japan - - - - B31
Azerbaijan - - - - B15 Egypt - - - - B22 Jordan - - - - B31
Bahrain - - - - B15 El Salvador - - - B22 Kazakhstan - - - B31
Bangladesh - - - B15 Equatorial Guinea - - B23 Kenya - - - - B32
Belarus - - - - B15 Eritrea - - - - B23 Kiribati - - - - B32
Belgium - - - - B16 Estonia - - - - B23 Kyrgyzstan - - - - B32
Benin - - - - B16 Ethiopia - - - - B23 Lao People’s Democratic
Republic - - - - B32
Bhutan - - - - B16 Fiji - - - - - B24
Latvia - - - - B32
Bolivia (Plurinational State of) B17 Finland - - - - B24
Lebanon - - - - B33
Bosnia and Herzegovina - B17 France - - - - B24
Libya - - - - - B33
Botswana - - - - B17 Gambia - - - - B25
Lithuania - - - - B33
Brazil - - - - B17 Georgia - - - - B25
Luxembourg - - - B34
Brunei Darussalam - - B17 Germany - - - - B25
Madagascar - - - B34
Bulgaria - - - - B18 Ghana - - - - B26
Malaysia - - - - B34
Cambodia - - - - B18 Greece - - - - B26
Maldives - - - - B34
Canada - - - - B18 Grenada - - - - B26
Mali - - - - - B35
China - - - - B19 Guatemala - - - - B27
Malta - - - - B35
Colombia - - - - B19 Guinea - - - - B27
Mexico - - - - B35
Democratic Republic of the Congo Guyana - - - - B27
B19 Monaco - - - - B36
Honduras - - - - B27
Congo - - - - B19 Montenegro - - - B36
Hungary - - - - B28
Cook Islands - - - B19 Morocco - - - - B36
Iceland - - - - B28
Costa Rica - - - - B20 Namibia - - - - B36
India - - - - - B28
Croatia - - - - B20 Nepal - - - - B37
Indonesia - - - - B28
Cuba - - - - B20 Netherlands - - - B37
Iran (Islamic Republic of) - B29
Cyprus - - - - B20 New Zealand - - - B37
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Nicaragua - - - - B38 Saudi Arabia - - - B43 Trinidad and Tobago - - B48
Niger - - - - B38 Senegal - - - - B43 Tunisia - - - - B48

Nigeria - - - - B38 Serbia - - - - B43 Türkiye - - - - B48
North Macedonia - - B38 Sierra Leone - - - B43 Uganda - - - - B49
Norway - - - - B39 Singapore - - - - B44 Ukraine - - - - B49
Oman - - - - B39 Slovakia - - - - B44 United Kingdom of Great
Britain and Northern Ireland B49
Panama - - - - B39 Slovenia - - - - B44
United Republic of Tanzania - B50
Paraguay - - - - B39 South Africa - - - B45
United Arab Emirates - - B50
Peru - - - - - B40 South Sudan - - - B45
United States of America - B50
Philippines - - - - B40 Spain - - - - B45
Uruguay - - - - B51
Poland - - - - B40 Sri Lanka - - - - B46
Uzbekistan - - - B51
Portugal - - - - B41 Sudan - - - - B46
Venezuela (Bolivarian
Qatar - - - - B41 Syrian Arab Republic - - B46
Republic of) - - - B51
Republic of Korea - - B41 Sweden - - - - B46
Yemen - - - - B51
Republic of Moldova - - B42 Switzerland - - - B46
Zambia - - - - B51
Romania - - - - B42 Tajikistan - - - - B47
Zimbabwe - - - - B51
Russian Federation - - B42 Thailand - - - - B47
Rwanda - - - - B42 Timor-Leste - - - B47
Sao Tome and Principe - B43 Togo - - - - - B47
Conclusion .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. B52
Acknowledgements .. .. .. .. .. .. .. .. .. .. .. .. .. B52
References .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. B53
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For a long time, the need of a common Medical Devices nomenclature available for all WHO member
countries has been acknowledged and recently during the COVID-19 pandemic its absence has been
painfully felt.
The objective of this work is to present and summarize the information available concerning the existence
and use of nomenclatures in the world.
Analysis of the Nomenclature Systems

The Country Survey of Medical Devices (2020) as well as the Nomenclature consultations (2021-2022)
are of particular interest in the context of our research since both of them covered several cross-cutting
themes concerning medical devices and collected a significant amount of data during different periods .
Its latest updated versions (2020-2022), in which 180 countries took part, comprises data summarized in
the Global Atlas of Medical Devices 2022 regarding the key points of our research that are listed as follows:
• countries that reported to have an official nomenclature system;
• type of medical devices nomenclature system reported as official;
• purpose of use of the medical devices nomenclature reported as official;
• variability of the parameters mentioned above by Region.
.
More than a half of the responding member states, i.e., 99 (51%) have an official nomenclature system for
medical devices, and 81 (42%) did not have an official one. A total of 14 countries (7%) did not participate
in the survey (see Fig. 1).
14
(7%)
Official
nomenclature
system
Do not have
81 an official one 99
(42%) (51%)
Data not
available
n=194
Figure 1. Existence of an official nomenclature system for medical devices (data from the 2020 Country survey and
the 2021-2022 Nomenclature consultations)
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In addition, 105 member states use, at least, one nomenclature system with the following types: 18% a
Nationally developed nomenclature system, 9% use the Universal Medical Device Nomenclature System
(UMDNS), 8% use the Global Medical Device Nomenclature (GMDN), 5% use more than one system and
15% uses the European Medical Device Nomenclature (EMDN) (see Fig. 2).
Nationally
developed
32 (18%)
None ofﬁcially
Based (do not have)
on EMDN 81 (45%)
27 (15%)
Based
on GMDN
15 (8%)
Based More than
on UMDNS one system
16 (9%) 9 (5%) n=180
Figure 2. Type of an official nomenclature system for medical devices (data from the 2020 Country survey and the
2021-2022 Nomenclature consultations)
The majority of countries that reported having an official nomenclature for their medical devices did not
specify a purpose of use, i.e., 34 (34%). While regulatory purposes, in particular 28 of 42 countries from
the European Region (EUR), was the most reported purpose of use. To a lesser extent, procurement
purposes and various purposes were reported i.e. 12 (12%) and 11 (11%), respectively, for all countries in
all regions (see Fig. 3).
50 3
For various purposes
8
40 3 For regulatory purposes
For procurement
30
28 For regulatory and
procurement purposes
20
2 Not specified
4 4
10 2 3 1
2
1
2
3
1
3 3 2
1 9 7
4 5 5 4
0 n = 99
AFR AMR EMR EUR SEAR WPR
Figure 3. Nomenclature system purpose of use by WHO regions
12 (data from the 2020 Country survey and the 2021-
2022 Nomenclature consultations)
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Desk Review
Methodology
We collected and compared information about whether state members of the WHO had a nomenclature
system in place and publicly available through the web, as well as the type and use of the nomenclature.
There were three main sources of information:
• C
ountry answers, comments and websites shared by the member countries (explained in the Sources
section).
• Desk Review
» Search for webpages
» Search for studies such as journal articles, reports, and thesis using Medline and Google scholar
The Desk Review search was conducted during the months of February, March and April 2021, with a
final update made in December 2021. The following search string was used in Google and Medline search
engines:
COUNTRY NAME AND (“NOMENCLATURE” OR “CLASSIFICATION” OR “REGULATION”

OR “SYSTEM”) AND (“MEDICAL DEVICES” OR “MEDICAL EQUIPMENT”)
If no relevant hits were found in English, a reviewer would translate to the country’s official language.
When reviewers did not yet find an answer, they tried synonyms, and then proceeded by searching and
reading anything related to laws and commercial sites on medical devices in order to find the appropriate
wording for the search terms in the target language and adjust the search accordingly. In many cases,
they also looked for clues into the Ministry of Health website, searched for dedicated agencies and
eventually for procedures regarding import of medical equipment.
World Health Organization

The topic of the medical devices nomenclature, has been addressed by the WHO Executive Board and
the World Health Assembly from 2018 to 2022. In 2007 the WHA60.291 resolution on health technologies
addressed needs for norms and standards for Medical devices. In 2018 WHO proposed the principles for
a nomenclature system, stating that it should be available as a public good, with transparent governance
and methodology, and be able to be referenced in systems, among other conditions. The WHA75 report
of the director general includes the activities been done by WHO in the previous 3 years, including
multiple consultations with stakeholders, nomenclature agencies, and a mapping pilot process.
In May 2022, a decision was taken by the World Health Assembly WHA75(25) to integrate available
information related to medical devices, including terms, codes and definitions, in the web-based database
and clearinghouse established in line with resolution WHA60.29 (2007) and now available as the Medical
Devices Information System (MEDEVIS); and to link this to other WHO platforms, such as the International
Classification of Diseases (ICD-11), to serve as a reference to stakeholders and Member States; (2) to
submit a substantive report on progress made in implementing this decision to the Executive Board at
its 152nd session in January 2023 and its 156th session in January 2025.
More information on the process can be found at WHO medical devices Nomenclature page2.
1 https://apps.who.int/gb/ebwha/pdf_files/WHASSA_WHA60-Rec1/E/cover-intro-60-en.
pdf?search=WHA60.29=true#WHA60.29
2 https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75(25)-en.pdf
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International and regional agreements
In addition to country-by-country analysis we also examined the regulation of medical devices, in

particular in terms of nomenclature systems, at the international and regional level.
Various countries as well as corporations use the United Nations Standard Products and Services
Code (UNSPSC) alongside the Harmonized Commodity Description and Coding Systems (HS) to trade
products, including medical devices.
European Union
The member states of the European Union use different nomenclature systems of medical devices (for
more details by country, please, consult Annex 2 - Findings by country), however, the EU has currently
adopted a common nomenclature system - the European Medical Device Nomenclature - (FAQ on
EMDN) that will be based primarily on Classificazione Nazionale Dispositivi medici (CND).
As a Regulatory requirement in the European Union, set by the publication to the Regulation (EU)
2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
(IVDR), the EMDN3 (European Medical Device Nomenclature) is the nomenclature that manufacturers
shall use for the registration of medical devices in EUDAMED4, where it is associated to each Unique
Device Identifier - Device Identifier (UDI-DI)5.
According to the Global Atlas of Medical Devices 2022, all 27 countries of the European Union reported
the use of EMDN i.e., around 15% of the countries in the world.
The Southern Common Market (MERCOSUR)

MERCOSUR has developed the Mercosur Common Nomenclature (MCN) that is based on the Harmonized
Commodity Description and Coding System developed by the World Customs Organization (WCO). The
MCN provides information concerning a wide range of products including medical devices.
The member countries of MERCOSUR agreed to use the MCN in terms of importing and exporting
commodities, however, some of the countries use nationally developed or other types of nomenclature
systems, for more detailed information about each member of MERCOSUR, please, consult Annex 2 -
Findings by country.
Association of Southeast Asian Nations (ASEAN)

One of the key documents that addresses several issues concerning medical devices regulation within
ASEAN is the ASEAN Medical Device Directive (AMDD). The AMDD includes provisions under which
the member states committed themselves to harmonize the sphere of medical devices regulation to
facilitate trade and cooperation.
3 EMDN - Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in
vitro diagnostic medical devices (IVDR).
4 EUDAMED - Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 30 of Regulation (EU) 2017/746 on
in vitro diagnostic medical devices (IVDR).
5 UDI System - Article 27 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 24 of Regulation (EU) 2017/746
on in vitro diagnostic medical devices (IVDR).
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United States-Mexico-Canada Agreement (USMCA)
Although the USA, Canada, Mexico within the United States-Mexico-Canada Agreement (USMCA)
are advancing towards more integrated environment in terms of regulatory framework convergence
(the USITC document), in particular developing the same risk-based classification of medical devices,
countries do not use a common nomenclature system of medical devices.
African Medical Devices Forum (AMDF)

The African Medical Devices Forum (AMDF), under the auspices of the African Union, serves as a platform
for enhancing integration and regulatory framework convergence in the context of medical devices.
African Medical Devices Forum
Asian Harmonization Working Party (AHWP)

Global Harmonization Working Party (formerly known as the Asian harmonization working party: the AHWP)
with members from Asia, Africa, Middle East and South America facilitates the process of regulatory framework
convergence.
Related links below:
Playbook for Implementation of a Medical Device Regulatory Framework
Requirements of Medical Devices Nomenclature for the AHWP (2010)
Asian Harmonization Working Party (AHWP)
International Medical Device Regulators Forum (IMDRF)

The International Medical Device Regulators Forum (IMDRF) “is a voluntary group of medical device
regulators from around the world who have come together to build on the strong foundational work of
the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international
medical device regulatory harmonization and convergence.”
IMDRF Adverse Events Working Group developed a nomenclature for the adverse events reporting,
including terminology and codes (see the IMDRF Terminologies for Categorized Adverse Event Reporting).
IMDRF strategic plan for 2021-2025 can be found here.
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Comparison of desk review (2021) versus the Country survey
(2020) and Nomenclature consultations (2021-2022)

The Country survey (2020) and the Nomenclature consultations (2021-2022) collected data about 180
countries, and the desk review (2021) gathered information about four more, bringing the total number
of countries that we have information about to 184. Nevertheless, the nomenclature system status of
10 countries remains unknown. Although some gaps in the data provided by the member states on the
Country survey (2020) and the Nomenclature consultations (2021-2022) were covered through the web
and literature search of the desk review, the difference between both data sets can also provide some
insight about the accessibility of such information, either public or through the country itself.
For example, both the Country survey (2020) and the Nomenclature consultations (2021-2022) and
the desk review showed that more than a third of the respondent members do not have an official
nomenclature coding structure for the proper management of their medical devices. There is a 10%
difference between the former, i.e., 45% (81 countries) and 35% (64 countries) for the last.
The same percentage difference, 10%, was shown concerning a specific type of official nomenclature
usage, i.e., 58% from the Country survey (2020) and the Nomenclature consultations (2021-2022) and
65% found in the desk review.
For more than one system, there is a difference of 27% between what member countries indicated
through their responses, i.e., 9 countries (5%) versus 58 countries (32%) found through the desk review.
The UMDNS showed a use difference of 2% (9% from the Country survey (2020) and the Nomenclature
consultations (2021-2022) versus 7% from the desk review), corresponding to 16 and 12 countries,
respectively; the nationally developed nomenclature showed a difference of 1% (Country survey (2020)
and the Nomenclature consultations (2021-2022): 18% vs. desk review: 17%; corresponding to 32 and 31
countries, respectively); and a percentage difference of 13% was found between the countries that use
the EMDN, i.e., 27 respondent countries (15%) versus 4 countries (2%) whose information was found
through the desk review.
Finally, the countries whose nomenclature is based on the GMDN showed no percentage difference
between the data from the Country survey (2020) and the Nomenclature consultations (2021-2022) and
the desk review (2021), i.e., both of them with 15 countries (8%).
Regarding the official nomenclature system purpose of use, and comparing the results between the data
obtained through the Country survey (2020) and the Nomenclature consultations (2021-2022) and the
desk review (2021), the following was obtained:
The not specified purpose of use corresponds to the largest percentage of countries in both the Country
survey (2020) and the Nomenclature consultations (2021-2022) and the desk review (2021), i.e., 34%
(34) and 40% (38), respectively. This can be explained by the difficulty of specifying the various uses of
the nomenclature system of medical devices within a country’s health system.
Between the number of the responding country members Country survey (2020) and the Nomenclature
consultations (2021-2022) and the gathered information (desk-review), the South-East Asia Region
(SEAR) and the Western Pacific Region (WPR) exhibited a difference of no more than two countries and
a similar distribution for their assorted nomenclature system purposes.
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Concerning specific purposes of nomenclature systems, all WHO Regions showed a comparable number
of countries using their nomenclature for procurement purposes and both regulatory and procurement
purposes, respectively 18 from the Country survey (2020) and the Nomenclature consultations (2021-
2022) and 19 from the desk review. However, in comparison to the preceding, a greater number of the
member countries stated the various purposes of use for their nomenclature system, at least in the case
of the desk review (23 versus the 11 from the Country survey (2020) and the Nomenclature consultations
(2021-2022)).
In comparison to other specific uses, most of the WHO regions have been found to mainly use three
specific purposes of use for their medical devices: regulatory, procurement, or both regulatory and
procurement purposes: 54% from the Country survey (2020) and the Nomenclature consultations (2021-
2022) and 32% from the desk review, for example: the African Region Country survey (2020) and the
Nomenclature consultations (2021-2022): 6 countries and the desk review: 4 countries; the European
Region (EUR) Country survey (2020) and the Nomenclature consultations (2021-2022): 30 countries
and the desk review: 8 countries; the WPR Country survey (2020) and the Nomenclature consultations
(2021-2022): 4 countries and the desk review: 5 countries; the Americas Region (AMR) and the Eastern
Mediterranean Region (EMR) Country survey (2020) and the Nomenclature consultations (2021-2022)
and desk review, with 10 and 4 countries, respectively. The SEAR Country survey (2020) and the
Nomenclature consultations (2021-2022), as well as the desk review, found no evidence of any of the
nomenclature-specified purposes mentioned above.
If contrasted to what was identified in the desk review, the regulatory purpose for medical devices has
been enlarged and specified as the number of country members in the EUR adopting the EMDN has
grown, i.e., 36 (36%) from the Country survey (2020) and the Nomenclature consultations (2021-2022)
versus 12 (13%) found in the desk review.
Many of the differences can be explained by the following:
• It is important to note that the Country survey (2020) and the Nomenclature consultations (2021-2022)
responses, despite being from different time periods, had a recent and significant participation from
the responding member states during the 2021–2022 period. This participation derived, particularly, in
the Executive Board, and World health assembly discussion and information sessions on nomenclature
of medical devices.
• The existence of a nomenclature system, type, and use is a continuous and rapidly evolving area of
medical devices that depends on many factors, such as legislation, commerce, management, political
will, economy, etc.
• As previously shown the specific purposes for the use of the nomenclature system, if any, are
rarely mentioned such as the following: for reimbursement purposes; for national essential lists; for
inventory systems in healthcare facilities. This may be explained due to lack of visibility of any or
specific purposes within the Health system and the absence of centralized information concerning the
different areas involved in Health technology.
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Findings by country
The desk review (2021) findings by country concern qualitative national information. And, as stated in the
Methodology, the medical devices surveys, from previous years until now, included comments related to
the nomenclature system of the member states. Although, some of them have been updated with the latest
Country Survey (2020) and the Nomenclature consultations (2021-2022) data and its qualitative analysis.
Concerning regional nomenclature agreements, the information can be found in the dedicated
International Agreements section.
Below, please find the list of member states with no comments about nomenclature type or use, and a
section with the countries that provided the corresponding comments (including them).
Countries without comments referring to nomenclature

No qualitative information was found during the desk review (nor sent during Country Survey (2020) or
the Nomenclature consultations (2021-2022)) about the nomenclature type, and use of the following 51
member states:
Afghanistan Micronesia (Federated States of)

Algeria Mongolia
Andorra Mozambique
Antigua and Barbuda Myanmar
Bahamas Nauru
Barbados Niue
Belize Pakistan
Burkina Faso Palau
Burundi Papua New Guinea
Cameroon Saint Kitts and Nevis
Cabo Verde Saint Lucia
Central African Republic Saint Vincent and the Grenadines
Chad Samoa
Chile San Marino
Comoros Seychelles
Côte d’Ivoire Solomon Islands
Democratic People’s Republic of Korea Somalia
Gabon Suriname
Guinea-Bissau Swaziland (Eswatini)
Haiti Tonga
Kuwait Turkmenistan
Lesotho Tuvalu
Liberia Vanuatu
Malawi Vietnam
Marshall Islands
Mauritania
Mauritius
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Countries with comments referring to nomenclature
The following section includes the corresponding information from 143 member states that have
submitted comments to Country Survey (2020) and/or the Nomenclature consultations (2021-2022), as
well as the information retrieved in the 2021 desk review consultation.
Albania
Country survey (2020) and Nomenclature consultations (2021-2022)
2020
This Italian nomenclature system CIVAB comes with the Inventory system called CLINGO.
Desk review up to December 2021

The registration list for medical devices in Albania and the codes that appeared belong to CIVAB
nomenclature. Nomenclature is used mainly for registration and inventory purposes.
https://www.humatem.org/telecharger_document_base_documentaire/88
http://akbpm.gov.al/shperndarja-e-barnave-dhe-pajisjet-mjekesore/
Angola
Access to the information is restricted since user accounts and passwords are required to access the
website of the Ministry of Health.
Argentina
2021-2022
The Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT), reported the
use of the Universal Medical Device Nomenclature System (UMDNS) for regulatory purposes of the
medical devices in this country6.

Medical equipment research in the national inventory revealed that identification codes and technical
names of medical equipment are similar to the ones that are used in UMDNS.
[When searching for medical equipment in the national inventory, identification codes and technical
names are UMDNS.]
https://helena.anmat.gob.ar/uploads/pdfs/dc_17612_30714838411_8533.pdf?rnd=ade6bf84-fed4-48cb-b11f-
c7b913a302ea
6 Answered to the September 2021 Survey for the GAMD 2021 Update.
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Armenia

Armenia uses a nomenclature that was developed within the Eurasian Economic Union (see first link,
paragraph 8, an official website). The Eurasian Economic Commission (EEC) and the GMDN Agency
signed the Memorandum of Understanding (2nd link) to support the harmonization of Eurasian Economic
Union’s (EAEU) medical device nomenclature with the GMDN. The common market of medical products
within the Eurasian Economic Union (EAEU) begins to function in full in 2022.
https://portal.eaeunion.org/sites/odata/redesign/Pages/MedicalDeviceNomenclature.aspx
http://www.eurasiancommission.org/en/nae/news/Pages/19-03-2019-3V.aspx
https://www.e-draft.am/projects/222/about
http://www.pharm.am/index.php/ru/2015-06-03-16-27-43/3571-2017-11-28-13-33-46
Australia
2021-2022
The use of GMDN is a legally mandatory requirement for devices supplied in Australia, including IVDs.

The Therapeutic Goods Administration site (Australian Regulatory Agency) states the use of GMDN, for
medical devices including IVDs.
https://www.tga.gov.au/global-medical-device-nomenclature-gmdn
https://www.tga.gov.au/sites/default/files/ivd-gmdncodes.pdf
After publication of the first draft of this Overview, the Therapeutic Goods Administration (the responsible
agency for regulating medical devices in this country) pointed out that the nomenclature used in Australia
for medical devices, including IVDs, is the Global Medical Device Nomenclature System (GMDN), which
is a legal and mandatory requirement for the devices supplied in this country.7
Austria
2021-2022
As per regulation 2017/45 on medical devices and Regulation (EU) 2017/746, the EU Member States
Competent Authorities of MD representatives (of both the national MoH and the national agencies)
of the MDCG, have opted for the publicly available, accessible and transparent nomenclature named
European Medical Device Nomenclature (EMDN)
2020
The Austrian Medical Devices Register uses the UMDNS and the EDMA Code.
https://goeg.at/Medizinprodukteregister
The Austrian Medical Devices Register uses the UMDNS, GMDN and EDMA Code for IVDs. In the future,
the CND/EMDN will be used as part of the European Commission Standard.
https://goeg.at/Medizinprodukteregister
https://medizinprodukteregister.at/Nomenklaturen
7 Commented by email to the publication of the Draft Nomenclature Overview

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Azerbaijan
State registration of medical devices is not carried out by the government. For import of medical products
and medical equipment, it is necessary to obtain a confirmation letter regarding the classification of an
imported product, and then obtain a hygienic certificate from the Republican Center for Hygiene and
Epidemiology of the Republic of Azerbaijan.
http://www.pharma.az/
Bahrain
2020
The GMDN code is required for registration of medical devices, as well as the HS code.
https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/
guidelines/MDR_Guideline_Medical%20Device%20Registration_%20Ver%206.0.pdf
https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/forms/
Medical%20Device%20Registration%20Form%20%2020%20Dec%202020.pdf
https://www.gmdnagency.org/Services/Members#N
According to the 19 sub-section of the Registration Guideline for medical devices (from the National
Health Regulatory Authority), for registration purposes, it is needed the GMDN and the HS code. In
some cases, it might be required to fulfil the classification criteria issued by the NHRA Medical Devices
Regulations department (it should be provided).
Bangladesh
A medical equipment price list can be found on the website of the Directorate General of Drug
Administration, but naming systems are not provided.
https://www.dgda.gov.bd/index.php/2013-03-31-05-16-29/registered-medical-device-list
Belarus
2020
State register of medical equipment and medical supplies of Belarus.
https://www.rceth.by/Documents/3mz3prN132420141216.pdf
Country uses the EEU’s nomenclature system alongside the nationally developed one. The Eurasian
Economic Commission (EEC) and the GMDN Agency signed the Memorandum of Understanding (2nd
link) to support the harmonization of Eurasian Economic Union’s (EAEU) medical device nomenclature
with the GMDN.
https://www.rceth.by/Documents/3mz3prN132420141216.pdf
https://pravo.by/document/?guid=3871&p0=F91800087
http://www.eurasiancommission.org/en/nae/news/Pages/19-03-2019-3V.aspx
B15
Belgium

2021-2022
2020
The GMDN code is used during the notification of the placing on the market of class I medical devices,
it is also used in the form for the transmission of material vigilance incidents. This code is also used for
the registration of diagnostic medical devices in vitro in the European database Eudamed; in Belgium,
several agencies are involved in the evaluation and regulation of devices.
(Original in French) Le code GMDN est utilisé lors de la notification de mise sur le marché des dispositifs
médicaux de classe I, il est également utilisé dans le formulaire de transmission des incidents en
matériovigilance. Ce code est également utilisé pour l’enregistrement des dispositifs médicaux de
diagnostique in vitro dans la base de données européennes Eudamed; in Belgium, several agencies are
involved in the evaluation and regulation of devices.
https://kce.fgov.be/en
https://www.famhp.be/en
The country uses the GMDN, and as it is a member of the EU it will be used in parallel with CND/EMDN.
https://ec.europa.eu/health/sites/health/files/md_topics-interest/docs/md_emdn_eudamed_nomenclature_
en.pdf
Benin
2020
The CNEH nomenclature is used informally in some of the country’s hospitals.
(Original in French) La nomenclature CNEH est utilisée de façon informelle dans certains de nos hôpitaux.
http://www.sante.gouv.bj/
The adoption of national and / or international nomenclatures for the identification of infrastructure,
biomedical equipment and care structures is an important prerequisite for the establishment of
harmonized management of health assets across the country.
(Original in French) L’adoption de nomenclatures nationales et/ou internationales pour l’identification
des infrastructures, des équipements biomédicaux et des structures de soins est un préalable important
pour la mise en place d’une gestion harmonisée du patrimoine sanitaire à travers le pays.
http ://www.sante.gouv.bj/
https ://www.jhia-online.org/index.php/jhia/article/download/179/110/664
Bhutan
2021-2022
Adapted nomenclature from the GMDN.

There is a national medical devices list that is based on the nationally developed nomenclature.
http://www.moh.gov.bt/national-medical-devices-list/
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Country uses the UMDNS as well as the Mercosur Common Nomenclature (MCN).
http://www.agemed.gob.bo/
https://www.mercosur.int/bolivia-ingresa-al-mercosur/
There is a national medical devices list (LINADIME) and it is not based in any of the internationally recognized
nomenclature
https://www.agemed.gob.bo/archivo_uso_racional/linadime/R.A.LINADIME.pdf

2020
The nomenclature is based on GMDN and EDMA codes; the instructions request manufacturer and
representative of manufactures to use GMDN or EDMA codes for making generic names. This country
have free access to the GMDN base, and found a new version of EDMA codes on the internet.

The nomenclature is based on the GMDN and the EDMA codes.
http://www.fmoh.gov.ba/index.php/zakoni-i-strategije/zakoni/zakon-o-lijekovima-i-medicinskim-sredstvima
Botswana
Country uses the UMDNS.
https://www.bomra.co.bw/index.php/bomra-downloads/guidelines-manuals
Brazil
2020
Anvisa started working to internalize the GMDN. So far, 100 of Anvisa’s technical names are compatible
with GMDN. Anvisa also works in the implementation of the Unique Device Identification (UDI) in Brazil.
Anvisa is currently preparing a draft proposal in a working group with the participation of the private
sector, which was sent to the Public Consultation (2021).
https://www.anvisa.gov.br/datavisa/nomestecnicosggtps/consulta_ggtps.asp
www.anvisa.gov.br
Brazil’s regulatory agency uses the GMDN system. For importation the Mercosur Common Nomenclature
is used.
https://www.gov.br/anvisa/pt-br
Brunei Darussalam
The UMDNS is used for regulatory purposes (see second link). Country is a Member of the Asian
Harmonization Working Party (AHWP). Within the AHWP efforts are being made to start developing a
unified medical devices nomenclature system for regulatory purposes.
http://www.ahwp.info/index.php/node/57
https://www.dgra.de/media/pdf/studium/masterthesis/master_matthies_c.pdf
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Bulgaria

2021-2022
2020
Uses GMDN and UMDNS.
https://www.mh.government.bg/en/
https://www.bda.bg/en/information-for-companies/122-medical-devices-announcements-category
It uses the GMDN and the UMDNS, and as a member of the EU it will use the CND/EMDN.
https://www.mh.government.bg/en/
https://www.bda.bg/en/information-for-companies/122-medical-devices-announcements-category
Cambodia
2020
The Hospital Service Bureau has developed standard medical equipment nomenclature for public
hospitals in Cambodia and it has been utilized for medical equipment management and maintenance.
Canada
2021-2022
Not publically available. Used internally for coding products in the database. Preferred Name Codes are
based on US FDA Panel Codes.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/
announcements/notice-global-medical-device-nomenclature.html
Health Canada is initiating the transition from its current medical device categorization method to
the Global Medical Device Nomenclature (GMDN) to improve the availability, access to, and quality of
information available on medical devices in Canada (see first link).
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/
announcements/notice-global-medical-device-nomenclature.html
After the publication of the first draft of this Overview, the Directorate of Medical Devices/Health Canada
specified that two types of nomenclatures for medical devices coexist in this country: the Global Medical
Device Nomenclature System (GMDN) and preferred name codes. In addition, it was clarified that
although Canada continues to accept PNC and encourage manufacturers to use the GMDN, it has never
been the intention to use any other nomenclature other than those mentioned above, nor to develop a
national one.8
8 Commented by email to the publication of the first Draft Nomenclature Overview

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China
Based on the UMDNS (China has plans to develop a uniquely identifiable database for medical equipment).
http://english.nmpa.gov.cn/2019-12/10/c_456290.htm
Colombia
2021-2022
Nationally developed. It is in the phase of implementation.
https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/DE/DIJ/resolucion-2535-de-2013.pdf
https://www.invima.gov.co/
Currently, the country is in resolutions to generate a interoperable semantic standard.
https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/MET/analisis-estandar-semantico-
dispositivos-medicos.pdf

2020
The official nomenclature does not exist. This country uses “whatever is at hand an according to its
circumstances”.
(Original in French) La nomenclature officielle n’existe pas. Tout ce qui est à portée de main et selon les
circonstances est utilisé.
Congo
2021-2022
Via the “Questions for Biomedical / Clinical Engineers” survey, the private HTM-Consulting pointed out
the coexistence of many nomenclature systems within this country, as there is not a specific one in official
use. As reported by the private agency, this situation has caused errors and mismatches regarding the
purchase of specific medical devices.9
Cook Islands
Regulated by MOH
https://www.health.gov.ck/policies-guidelines/
9 Answered to the August 2021 Survey “Questions for Biomedical / Clinical Engineers”
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Costa Rica

2020
The GMDN has been adapted to the national needs.
https://www.ministeriodesalud.go.cr/index.php/acceso-a-sistemas-de-informacion
Costa Rica has a national nomenclature system for classifying medical equipment.
http://www.pgrweb.go.cr/scij/Busqueda/Normativa/Normas/nrm_texto_completo.
aspx?param1=NRTC&nValor1=1&nValor2=62959&nValor3=99850&strTipM=TC
Croatia
2021-2022

Croatia uses the GMDN nomenclature for the national registration of medical equipment. As an EU
member, it will adopt the use of CND/EMDN too.
https://www.halmed.hr/Medicinski-proizvodi/Upute-za-podnositelje-zahtjeva-41/Proizvodnja-medicinskih-
proizvoda/
Cuba
2021-2022
The Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)
reported the coexistence and use for procurement purposes of two nomenclature systems: the SUCNEM,
a nationally developed nomenclature, based on the Universal Medical Device Nomenclature System
(UMDNS) and the Global Medical Device Nomenclature (GMDN)10.
https://www.cecmed.cu/
http://www.electromedicina.sld.cu
Cuba has its system for classifying medical equipment: SUCNEM, which is based on the UMDNS.
Additionally, the country uses the GMDN.
https://www.cecmed.cu/registro/equipos-medicos
http://cencomed.sld.cu/socbio2007/trabajos/pdf/conferencias/aguiar/viernes/mesa2/dulce.pdf
Cyprus
2021-2022
European Medical Device Nomenclature (EMDN).
10 Answered to the September 2021 Survey for the GAMD 2021 Update.
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Czechia
2021-2022
2020
The GMDN and UMDNS remain the historically used nomenclatures. Three national specific systems
(categorizations) of medical devices are used for reimbursement and statistical purposes. The GMDN
remains a comprehensively recognized system for the registration and notification of medical devices
in the Czechia. GMDN codes are used in the Register of Medical Devices (RZPRO) administered by
the State Institute for Drug Control (SUKL) for regulatory purposes, adverse events reporting, safety
corrective measures, and information on clinical trials.

It is used by the UMDNS for registration, and other types of medical device nomenclature for reimbursement
purposes. As a EU member it will adopt the use of CND/EMDN too.
https://www.niszp.cz/en/registration-and-notification
Denmark
2021-2022

The use of the GMDN system is in the law, but soon it will be used in alongside the CND/EMDN, as the
EU nomenclature.
https://laegemiddelstyrelsen.dk/en/devices/
Djibouti
Regulated by MOH
https://sante.gouv.dj/reglements
Dominica
No change. Neither in the web portal of the government nor the Ministry of Health, Wellness and New
Health Investment (the latest is in development) there’s no information about nomenclature of medical
devices.
http://health.gov.dm/
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Dominican Republic

2020
There is no official nomenclature. However, there is a proposal dating from 2006 that responded to a
project for preventive maintenance of medical equipment.
(Original in Spanish) No existe una nomenclatura oficial. Sin embargo, existe una propuesta que data del
año 2006 que respondió a un proyecto de mantenimiento preventivo de equipos médicos.

There is no official nomenclature system. The access to the Dirección General de Medicamentos, Alimentos
y Productos Sanitarios have only three windows of information about the process and certification of
medical devices, medicines and cosmetics; none of them is available for public navigation as a supplier
registration and password are needed; the only available classification (but not nomenclature system) of
medical devices is in the Oficial Decret No. 246-06, Book 2, chapter 1, articles 11 to 20.
https://digemaps.msp.gob.do/menu/
Ecuador
2021-2022
For MD traceability purposes will be taken as a reference the Universal Medical Devices Nomenclature
System (UMDNS) developed by Emergency Care Research Institute (ECRI). In case that UMDNS does not
have a specific code for a MD, it will be taken as an alternative nomenclature, the Global Medical Devices
Nomenclature developed by GMDN Agency.
https://www.controlsanitario.gob.ec/wp-content/uploads/downloads/2017/01/Resoluci%C3%B3n_ARCSA-026-
YMIH-Dispositivos-M%C3%A9dicos.pdf
Egypt
2020
Used in the database of geographical information system health.
https://www.edaegypt.gov.eg/
Medical devices registration requires use of a nomenclature (not specified, link 2).
https://www.edaegypt.gov.eg/
https://www.wikiprocedure.com/index.php/Egypt_-Register_with_Central_Administration_of_Pharmaceutical_
Affairs_(CAPA)
El Salvador
2021-2022
The catalog developed is for medical equipment in general and is for purchase purposes only. There is
no distinction or classification of medical technology equipment based on its application or impact on
the health of the patient
(Original in Spanish) El catálogo desarrollado es de equipo médico en general y sólo es para fines
de compra. No existe distinción o clasificación de equipos de tecnología médica por su aplicación o
incidencia en la salud del paciente.
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In the Dirección Nacional de Medicamentos is available the guide for medical devices registration. It
includes the classification of medical devices (see link).
https://www.transparencia.gob.sv/institutions/h-zacamil/documents/207883/download
Equatorial Guinea
Regulated by MOH
Eritrea
2020
Official nomenclature system for medical devices is currently in the process of development.
https://shabait.com/
Estonia
2021-2022

It uses the MSA code (nationally developed) although it also uses the GMDN, both for various purposes
such as regulation and procurement.
https://msa.sm.ee/eng/search/
https://msa.sm.ee/ctrl/en/Fail/laadi_alla_mall/96968
https://haigekassa.ee/en/people/medical-devices
https://www.terviseamet.ee/en/medical-devices-2/regulatory-controls-medical-devices
Ethiopia
2020
Nationally developed and based on both the UMDN and the GMDN. This nomenclature was developed
by EPSA, ESDA and FMoH in collaboration with stakeholders. The nomenclature is mainly used for
procurement and regulatory purposes. The Established Public Infrastructure Directorate is now starting
an inventory to identify the type, source and status of the devices.
www.fmhaca.gov.et
https://epsa.gov.et/featured-services/procurement-list/
The Guideline for Registration of Medical Devices includes the medical devices’ essential safety and
performance requirements, and risk classification I to IV. As well as a nationally developed nomenclature
as stated in the Ethiopian Food and Drug Administration (first link and third link). The second link shows
the registration form for medical devices.
http://www.fmhaca.gov.et/publication/guidelines-for-registration-of-medical-devices-or-supplies/
https://www.eris.efda.gov.et/public/registration
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Fiji

There is no specific nomenclature system. The procurement, management, inventory and registration use
the generic name or the trade name of the product (according to the 2013 policy).
http://www.health.gov.fj/wp-content/uploads/2018/02/Fiji-National-Medicinal-Products-Policy-2013.pdf
Finland
2020
Finland CA will implement the European Medical Device Nomenclature (EMDN) used by manufacturers/
ARs when registering their medical devices in the EUDAMED database. The EMDN system will be based
on the Italian CND nomenclature system. This will be the only official nomenclature system for medical
devices in Finland.
https://www.fimea.fi/web/en/medical-devices
The EMDN system will be based on the Italian CND nomenclature system. This will be the only official
nomenclature system for medical devices in Finland.
https://www.fimea.fi/web/en/medical-devices
https://www.fimea.fi/documents/160140/764068/english_Publications_Forms_IVDD_manufacturers_
formulaire.pdf/0d7e0ec9-072e-c61b-934d-2fa178875ddf?t=1577451373998
France
2021-2022
2020
The classification of the provisions of medical devices is provided for in Article R. 5211-7 of the Public
Health Code. The rules are specified in the order of March 15, 2010 amending the order of April 20, 2006
setting the classification rules for medical devices.
(Original in French) La classification des dispositions des dispositifs médicaux est prévue à l’article R.
5211-7 du code de la santé publique. Les règles sont précisées dans l’arrêté du 15 mars 2010 modifiant
l’arrêté du 20 avril 2006 fixant les règles de classification des dispositifs médicaux.
http://www.legifrance.gouv.fr/affichCode.do;jsessionid=3DA99E555F0AB933E0B91227088DB46C.
djo04v_3?idSectionTA=LEGISCTA000006190738&cidTexte=LEGITEXT000006072665&dateTexte=20100330
It is used as a nomenclature based on the GMDN (for procurement and commercialization), and as it is
in the EU it will be used in parallel with the EMDN (for different purposes such as regulation, registration,
procurement, surveillance, etc.).
https://www.legifrance.gouv.fr/codes/id/LEGISCTA000006190738/
https://www.ansm.sante.fr/Activites/Mise-sur-le-marche-des-dispositifs-medicaux-et-dispositifs-
medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/DM-classes-IIa-IIb-III-et-DMIA-Communication-et-liste/
(offset)/6#paragraph_25854
After publication of the first draft of this Overview, the Hôpitaux de Haute-Savoie/AFIB have expresed
the use, for more than 30 years, of the CNEH code nomenclature system (developed by the Center
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National d’Expertise Hospitalière) for the identification and management of any biomedical devices and
medical infrastructures in this country. This nomenclature in French language, is publicly available. In
addition, the inventory and management software system for medical devices (CMMS) uses the CNEH
codes to identify any medical device. It has also been specified that the Agence Nationale de Sécurité du
Médicament et des Produits de Santé (ANSM), formerly the AFSSAPS, is the agency in charge of giving
marketing authorizations for CE-marked medical devices, which in no case takes into consideration the
use of the GMDN nor the UMDN for classifying or identifying any medical device.11
Gambia
2020
The Medical Research Council (UK) in Gambia (refer to specific link) uses the UMDNS system via the
ECRI Health Devices Sourcebook (ECRI website). Note that this is not used by the Ministry of Health.
http://www.mrc.gm/
Georgia
2020
According to Georgian legislation, Georgia recognizes international or national (according to a list of
certain countries) certificates of medical devices there.
https://matsne.gov.ge/ru
The Law of Medicines and Pharmaceutical Activities (which includes the regulation of medical goods
or medical devices) proposes three groups on the classification of pharmaceutical products (article 11,
superindex 2) for advertising and retailing purposes. But there is no nomenclature system for medical
devices.
https://matsne.gov.ge/ru/document/download/29836/21/en/pdf
Germany
2021-2022
2020
At the German Institute for Medical Documentation and Information (DIMDI) German manufacturers or
an authorised representative of non-EU manufacturers have to register their products themselves. The
database is served by DIMDI and today uses UMDNS.
http://www.dimdi.de
11 Answered to the August 2021 Survey “Questions for Biomedical / Clinical Engineers” and commented by email
to the publication of the first Draft Nomenclature Overview.
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According to the information of the regulatory agency of Medical devices (BfARM) and the Ministry of
Health two systems are used: UMDS (for medical devices in general) and EMDN for IVD. Although it is
announced that both of them will be replaced (in May 2021) with the EMDN (European Nomenclature
system for medical devices) which itself is based on the Italian CND system.
https://www.dimdi.de/dynamic/de/medizinprodukte/bezeichnungssysteme/
Ghana
According to the “Guideline for registration of medical devices”, the GMDN will be required for registration
just in case it is previously coded. The nomenclature is used for registration purposes.
https://fdaghana.gov.gh/images/stories/pdfs/downloads/GUIDELINES%20FOR%20THE%20
REGISTRATION%20OF%20MEDICAL%20DEVICES-REVIEWED.pdf
Greece
2021-2022
2020
A specific technical committee is responsible for the correlation of Nomenclature, Classification and
Codification of Medical Devices.
https://www.gmdnagency.org/
A specific technical committee is responsible for the correlation of the nomenclature, the classification
and codification of medical devices.s The novel EMDN which is based on CND nomenclature will be
introduced soon as the official EU’s system. The National regulatory authority is the National Organization
for Medicines in charge of medical products and devices.
https://www.eunethta.eu/eof/
Grenada
2020
A system was developed but was not supported by management. There is no URL because this software
was locally developed.

The Ministry of Health website is not available for this country, nor the “Biomedical unit”, which is
responsible for the identification, procurement and maintenance of the medical equipment at the
Hospitals and the Community Health facilities; nevertheless, the Strategic Plan for Health 2016-2025 is
available and provides an in in which it is mentioned the lack of material and human resources.
http://www.gov.gd/moh/ced/mofa/sites/moh/files/grenada_health_sector_strategic_plan_2016-2015_
approved.pdf
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Guatemala
2021-2022
The In Vivo Classification, according to class, is contemplated in the Annex of the Technical Norm No. 37.
(Original in Spanish) La Clasificación In Vivo y según Clase se encuentra contemplada en el Anexo de la
Norma Técnica No. 37.
https://www.mspas.gob.gt/
https://medicamentos.mspas.gob.gt/
In accordance to the “Norma Técnica 37 versión 5-2016 Para la inscripción sanitaria de dispositivos
médicos” the nomenclature system use for regulation, surveillance and control of medical devices has
been nationally developed.
https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/normas-tecnicas?download=262%3Ainscri
pcion-sanitaria-de-dispositivos-medicos&start=40
Guinea
In the Medicines and Cosmetics Regulation 2002 Act it is indicated that medicinal products for
importation, manufacture, processing or packing should be done with the generic, official or approved
non-proprietary name found in official pharmacopoeias or formularies alongside the brand name.
https://wipolex.wipo.int/en/text/199156
Guyana
There is no official nomenclature for medical devices. The Regulation Agency (GAFDD) is in charge of
the registration of devices.
https://gafdd.gy/inspectorate/#
Honduras
2020
The Regulation for the Sanitary Control of Products, Services and Establishments of Sanitary Interest,
establishes a nomenclature for registration purposes.
(Original in Spanish) El Reglamento para el Control Sanitario de Productos, Servicios y Establecimientos
de Interés Sanitario, establece una nomenclatura con fines de Registro.
http://www.salud.gob.hn/site/
The ‘Reglamento de control sanitario 2005’ proposes a nomenclature system for sanitary license (art.
133/ unidad III) and for registration (art. 159, unidad V).
https://arsa.gob.hn/public/archivos/Reglamentocontrolsanitario62005.pdf
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Hungary

2021-2022
2020
The coding is not available on the Internet.

A national nomenclature system (and classification) has been developed for medical devices on “4/2009.
(III. 17.) Decree”; also, the acceptance of another nomenclature system such as the “Global device name”
for registration of products (see: “Annex II”). Although, as part of the EC it will use the EMDN (European
Nomenclature system for medical devices) too.
https://net.jogtar.hu/jogszabaly?docid=A0900004.EUM&celpara=#xcelparam
https://net.jogtar.hu/jogszabaly?docid=a0300008.esc
Iceland
It uses a nomenclature system for registration (see link). Although, as part of the EC it will use the EMDN
(European Nomenclature system for medical devices) too.
https://www.ima.is/medical_devices/about_medical_devices/
India
Regulated by the Central Drugs Standard Control Organization: CDSCO.
https://cdsco.gov.in/opencms/opencms/en/Home/
Indonesia
2020
It uses a Harmonization System code (HS) at the moment. After harmonization, GMDN will be used.

There are classification guidelines and a policy for the distribution of medical devices and IVDs. The
nomenclature systems mentioned in the regulation documents are the Harmonization System code (HS)
and the GMDN (see two links).
http://regalkes.kemkes.go.id/informasi_alkes/Pedoman%20Klasifikasi.pdf
http://regalkes.kemkes.go.id/informasi_alkes/PMK_No_62.pdf
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Regulated by IMDR (first link). For its registration, any medical device needs a declaration of conformity
as stated in GHTF STED which is accepted in the report in one of the following nomenclatures: National
developed classification (IRC Code: Iran Registration Code); EU classification or US-FDA classification.
However, in order to fulfil the whole documentation, the UMDNS classification is used.
http://imed.ir/
http://www.imed.ir/uploads/forms/documents/73a82691-3330-4eef-a1d1-36c769376672.pdf
http://imed.ir/ExtendedModules/Document/UI/DownloadFile.aspx?FileCode=a2ab141c-cd93-4904-8108-
56f912e9e6bb&fileid=411
Iraq
2020
The MoH is working on adapting a national nomenclature system and linking it to the UMDNS.
https://kimadia.iq/en
No official nomenclature system, but several such as UMDNS are accepted. The State Company for
Provision of Medicines and Medical Appliances (KIMADIA) oversees imported medical devices. oversees
imported medical devices. Tecmoh registers all medical devices in Iraq.
https://kimadia.iq/assets/files/1613646335_67-2021-2-%D8%A7%D8%B3%D8%B9%D8%A7%D8%B1-%D8%A7%
D9%84%D9%85%D9%81%D8%A7%D8%AA%D8%AD%D8%A9-%D8%A7%D9%84%D9%85%D8%B1%D9%82%D
9%85%D8%A9_1613646335.pdf
https://www.facebook.com/Iraqi-Pharmacovigilance-Center-IPhvC-%D8%A7%D9%84%D9%8
5%D8%B1%D9%83%D8%B2-%D8%A7%D9%84%D8%B9%D8%B1%D8%A7%D9%82%D9%8A-
%D9%84%D9%84%D8%B1%D8%B5%D8%AF-%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A
6%D9%8A-159782860751953/?hc_ref=ARSHWx4DaLIQXMMMAOzGGWzuyBIjp90GRSRgwilptidc_
P7hppyjNAGTkdxXOsm7KlQ&fref=nf&__tn__=kC-R
Ireland
2021-2022

For registration of medical devices, it is recommended to use the GMND nomenclature system (see
link 1), even if other nomenclatures are also accepted. Although as part of the EC it will use the EMDN
(European Nomenclature system for medical devices) too.
https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/aut-g0054-guide-to-
registration-of-persons-responsible-for-placing-medical-devices-on-the-market-v2.pdf?sfvrsn=10
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Israel

There is no official nomenclature, but the use of several nomenclatures is accepted, such as UMDNS,
for the registration of medical technologies (regulated by the Division of Medical Equipment (see first
link)). Risk Classification often uses the same as EC states. As in agreement with EC states, it may use
the EMDN (European Nomenclature system for medical devices) too. The risk classification for medical
devices used is divided into the following classes: I, IIa, IIb, and III (Decreto Legislativo 24 febbraio 1997,
Art. 8). [From (Samadi)]
https://www.health.gov.il/English/MinistryUnits/HealthDivision/MedicalTechnologies/MLD/Pages/default.aspx
https://medicaldevices.health.gov.il/
Italy
2021-2022
CND Classificazione Nazionale dei Dispositivi Medici (correlated with GMDN). CND was nationally
developped, and it is the base for EMDN. As mentioned on several occasions in the past, a map of
correspondence between the GMDN nomenclature and the Italian CND classification has been created
since 2007 to allow manufacturers to register in the Italian database of medical devices. This map is
subject to ongoing maintenance even today at the request of manufacturers. This map was introduced at
the beginning because the GMDN code was originally the mandatory registration key in the Italian system.
Subsequently, the mandatory use of the GMND code was removed at the request of the manufacturers,
due to the difficulty of using it and, in many cases, due to its unavailability. In any case, the possibility of
using the GMDN code and its connection with the CND is still allowed, but it appears that, despite this
possibility of use, the GMDN code is rarely used in the registration in the Italian system. A new version
of the Italian medical device nomenclature (CND) will be published within the next months. Because the
CND has been chosen as the basis of the EMDN nomenclature, a huge update has been done to create
the European nomenclature. All the updates have been acquired in the new version of the CND, that has
been approved by the Italian Technical Committee on 21st December 2020.|One of the most important
inputs for the CND update was the comparison with GMDN and so an alignment between the first level of
the CND 2018 version and GMDN (dataset 01/05/2019) has been done. A list of GMDN codes not covered
by CND has been defined and then used to create some new codes in CND. In the Meeting of the Medical
Device Nomenclature Working Group-04, OCTOBER 2019 of the European Commission, the state of the
art of mapping between CND and GMDN was a point of the agenda. Any further other mapping activities
must be agreed upon with the European Commission in line with the provisions of the project itself.
http://www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_15_file.pdf
http://www.salute.gov.it/portale/temi/p2_3_dispositivi.html
The Italian classification system (CND Classificazione Nazionale dei Dispositivi Medici) has been correlated
to the GMDN nomenclature, as well as it will be the basis for the future EMDN (European Nomenclature
system for medical devices) too, that will be the one used soon for EC states.
http://www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_15_file.pdf
http://www.salute.gov.it/portale/temi/p2_3_dispositivi.html
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Jamaica
There is the Standards & Regulations Division within the MoH. However, there is not mentioned a specific
nomenclature for registration of medical devices, nor for risk classification.
https://www.moh.gov.jm/divisions-agencies/divisions/standards-and-regulation-division/guidelines-forms-
lists/
https://moh.gov.jm/wp-content/uploads/2015/12/Ven-List-2015.pdf
Japan
2021-2022
Japanese Medical Device Nomenclature was developed from the GMDN 2003 version.
https://www.std.pmda.go.jp/stdDB/index_en.html
It uses a national nomenclature system called Japanese Medical device nomenclature (JMDN) - see
PMDA regulatory agency link for more details
https://www.std.pmda.go.jp/stdDB/index_en.html
https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/JMDN_en.pdf
https://www.pmda.go.jp/english/index.html
Jordan
2021-2022
This country will support the WHO standard nomenclature for medical devices. Until now, its nomenclature
is based on UMDNS for management in the CMMS system, and the government procurement department
uses UNSPSC nomenclature for procurement purposes.
http://www.jfda.jo/Default.aspx
Jordan relies on the EU directives to classify its devices, namely, the Medical Devices Directives 93/42/
EEC and the Active Implantable MDD 90/385/EEC and the Medical Devices Importation Directives, Art.
2.
http://www.jfda.jo/Pages/viewpage.aspx?pageID=153
Kazakhstan
2020
Medical State Register of lekarstennyh.
https://www.ndda.kz/category/nomenklatura_men_izd
It uses a nationally developed nomenclature system that is harmonized with the GMDN.
https://www.ndda.kz/category/nomenklatura_men_izd
http://nmirk.dari.kz/
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Kenya

2021-2022
The GMDN is used for regulatory purposes.
https://www.gmdnagency.org
The nomenclature is used for registration purposes. The following systems are allowed for registration
purposes: nationally developed, GMDN, UDI and UMDNS; as stated in the guidelines, at least, one system
must be used for registration of medical devices or IVDs (see link 1) alongside the risk classification for
medical devices A-D (see link 2).
https://pharmacyboardkenya.org/files/?file=Final%20Guidelines%20for%20Medical%20Devices%20and%20
IVDs.pdf
https://www.ghspjournal.org/content/ghsp/early/2021/03/24/GHSP-D-20-00578.full.pdf
Kiribati
The Medical Equipment Management Committee within the MoH is in charge of the registration of
medical equipment. There is no specific nomenclature used nor a risk classification system.
Kyrgyzstan
2020
The nomenclature is used for various purposes: regulation, procurement, in-vitro diagnostics lists and
inventory.
http://cbd.minjust.gov.kg/act/view/ru-ru/1197
http://cbd.minjust.gov.kg/act/view/ru-ru/111673
http://www.pharm.kg/ru/about

No change as no nomenclature system is mentioned on any guidelines, policy, rules or acts; in this
country, it is used the generic name of medical products or the active ingredients officially recognized
by the World Health Organization which are used worldwide and have no copyright owner, according to
“Law on drugs and medical products (Amended)(2011); Medical Devices risk classification A- D (law on
Drugs and Medical Products, Art. 11.).
http://www.fdd.gov.la/download/contents_documents/2019-07-05_100305am_Law%20on%20Medical%20
Products%20(Eng).pdf
Latvia
2021-2022
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According to art. 119,3. from “Procedimientos de registro, evaluación de la conformidad, distribución,
operación y supervisión técnica de dispositivos médicos”: the GMDN is accepted for registration
purposes. However, this country is not registered as a member of GMND agency.
http://www.zva.gov.lv
https://likumi.lv/ta/id/295401-medicinisko-iericu-registracijas-atbilstibas-novertesanas-izplatisanas-
ekspluatacijas-un-tehniskas-uzraudzibas-kartiba
Lebanon
2020
The Ministry of Health is planning to acquire the Global Medical Devices Nomenclature system to adopt
it and use it for regulatory and procurement purposes.
https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20
Regulations/karar%201506-2014.pdf
There is no official nomenclature for medical devices, but GMND is accepted as stated in the “Minister
Decision No. 1506 date 1/9/2014” page 1 (see link).
https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20
Regulations/karar%201506-2014.pdf
Libya
2020
For the medical equipment list it is used a nomenclature based on UMDNS. Nomenclature is used for
inventory systems in healthcare facilities and lists.
http://www.mhtc.ly
https://seha.ly/en
It is accepted the use of various nomenclature systems of medical devices for procurement and donations
(see link 2).
http://seha.ly/en/laws-regulations
https://mhtc.ly/docs/GeneralConditions/Generalcondition.pdf
Lithuania
2021-2022

Medical devices are divided into classes I-III according to their risk (MS 102, 17-19). The State Health Care
Accreditation Agency, MoH, is in charge of regulation. Although, as part of the EC it will use the EMDN
(European Nomenclature system for medical devices) too (see link 2).
https://vaspvt.gov.lt/node/78
http://vaspvt.taduliz.lt/node/44
https://vaspvt.gov.lt/node/1166
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Luxembourg

2021-2022

Although as part of the EC this country will use the European Nomenclature system for medical devices.
https://sante.public.lu/fr/support/recherche/index.
php?~=do&from=search&s=desc%28score%29&r%5B0%5D=f%2Fsection%2Flegislation&res_
length=20&q=dispositifs+m%C3%A9dicaux#main
Madagascar
2020
National nomenclature for the material accounting of State assets (codification for the technical
inventory).
(Original in French) Nomenclature nationale pour la comptabilité matière du patrimoine de l’Etat
(codification pour l’inventaire technique).
http://www.agmed.mg/
There is a nationally developed nomenclature. The regulation is in charge of L’Agence du Médicament de
Madagascar (AGMED).
http://www.agmed.mg/PDF/SI/doss/ARRETE-14993_2013_MSANP-modalit%C3%A9s_fabrication_
information_au_public_vente_dispositifs_m%C3%A9dicaux.pdf
Malaysia
2020
For medical devices registration it is used the HS Code (Harmonized Tariff Nomenclature and Coding
System) as well as the GMDN code (see link).
https://portal.mda.gov.my/documents/guideline-documents/30-guidelines-on-medical-device-registration-
under-act-737-mda-gl-md-01-june-2014-2nd-edition/file.html
Maldives
There is a project to develop a national nomenclature system based on the UMDNS (see: Situation analysis
report, Link 3).
http://health.gov.mv/
https://www.facebook.com/mfdamv-102808298333472/
https://www.researchgate.net/publication/260766912_Situation_Analysis_on_medical_equipment_in_
Maldives#fullTextFileContent
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Mali
2020
There is a summary nomenclature section in the stock accounting document where the different products
are classified by category, but this is a very important area that deserves action.
(Original in French) Il existe dans le document de la comptabilité matière une rubrique nomenclature
sommaire ou les différents produits sont classés par catégories, mais c’est un domaine très important
qui mérite une action.

http://www.cnop.sante.gov.ml/docs/LISTE%20AMO%20DANS%20LE%20SECTEUR%20%20
PHARMACEUTIQUE%20PRIVE%20-%20%20Edition%202018.pdf
Malta
2021-2022
Mexico
2021-2022
The nomenclature system is established and organized in charts for health technologies that can be used
in public/social health services. As for the government administration for 2018-2024, the charts will be
organized as a compendium and it is in the process of depuration.
2020
The nomenclature system is established and organized in charts for health technologies that can be used in
public/social health services. As for the government administration for 2018-2024, the charts will be organized
now as a compendium and it is in the process of depuration. https://www.gob.mx/cms/uploads/attachment/
file/512087/NOM-241-SSA1-2012.pdf
http://www.csg.gob.mx/descargas/pdf/priorizacion/cuadro-basico/iyem/catalogo/2017/EDICION_2017_
TOMO_II_EQUIPO_MEDICO_-_link.pdf
TOMO_I_INSTRUMENTAL_-_link.pdf
TOMO_ANEXO_SET_QUIRURGICOS.pdf
http://www.csg.gob.mx/descargas/pdf/priorizacion/cuadro-basico/aux_diag/catalogo/2017/EDICION_2017_
CByC-AUX_DE_DIAGNOST.pdf
http://www.csg.gob.mx/images/priorizacion/cuadro-basico/osteo-endo/catalogos/EDICION_2017_
MATERIAL_DE_OSTESxNTESIS_Y_ENDOPRxTESIS.pdf
https://www.gob.mx/cms/uploads/attachment/file/512083/NOM-229-SSA1-2002.pdf
https://www.gob.mx/cms/uploads/attachment/file/512207/NOM-137-SSA1-2008.pdf
https://www.dof.gob.mx/nota_detalle.php?codigo=5562796&fecha=14/06/2019&print=true
https://www.gob.mx/cofepris
http://www.csg.gob.mx/contenidos/priorizacion/cuadro-basico.html
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Monaco

2020
Directive 93/42/CEE.
https://www.gouv.mc/Gouvernement-et-Institutions/Le-Gouvernement/Departement-des-Affaires-Sociales-et-
de-la-Sante/Direction-de-l-Action-et-de-l-Aide-Sociales
There is a nationally developed nomenclature for medical devices. Medical devices and IVDs are grouped
by risk category: class I-III (arrêté ministériel n. 2003-581, Sec. I, Art. 1er). The Direction de l`Action
Sanitaire et Sociale within the MoH is in charge of the regulation of medical devices.
https://www.gouv.mc/Gouvernement-et-Institutions/Le-Gouvernement/Departement-des-Affaires-Sociales-et-
de-la-Sante/Direction-de-l-Action-et-de-l-Aide-Sociales
Montenegro
2020
“Register (notification) of medical devices” that contains information on medical devices which are
available for use in Montenegro has just recently been set up. As it is at the start of its operations, it will
use GMDN as a referent nomenclature system and based on this, it will be developed a system that will
be in Montenegrin language so that all users can use it properly and they will have information what is
on Montenegrin market as well.
https://www.calims.me/Portal/faces/dinamickeStrane?_Loop=4618826366059702&paramPut=+%3E+Medical+
Devices+%3E+Definitions+and+Classification&paramRender=2&paramS=70&_adf.ctrl-state=wn7tyvskh_894
It has recently developed a nomenclature system of medical devices based on GMDN.
https://www.calims.me/Portal/faces/dinamickeStrane?_
frLoop=4618826366059702&paramPut=+%3E+Medical+Devices+%
3E+Definitions+and+Classification&paramRender=2&paramS=70&_adf.ctrl-state=wn7tyvskh_894
Morocco
2020
Nomenclature based on ECRI and CNEH.
(Original in French) Nomenclature basée sur l’ECRI et le CNEH.
http://dmp.sante.gov.ma/classification?rlc=587d5c&tirt=Dispositifs%20m%C3%A9dicaux&id=8
It is based on the UMDNS.
http://dmp.sante.gov.ma/classification?rlc=587d5c&tirt=Dispositifs%20m%C3%A9dicaux&id=8
Namibia
Many nomenclatures are accepted as stated in the second link
https://www.rrfa.co.za/wp-content/uploads/2012/11/NAM-Medicines-Registration-Guidelines.pdf
http://www.nmrc.com.na/
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Nepal
A national nomenclature system is based on the GMDN and the UMDNS.
https://www.dda.gov.np/
https://www.dda.gov.np/content/health-technology-product-an-medical-device-directive-2074
Via the “Questions for Biomedical / Clinical Engineers” survey, the IFMBE-Clinical Engineering Division
(CED) explained that the lack of mandatory guidelines or official documents demanding the use of
one specific nomenclature system, as well as the coexistence of many nomenclatures in different
government health facilities in Nepal, has led to wrong procurements and mismanagement of medical
device inventories.12
Netherlands
2021-2022

There is a national nomenclature system based on the GMDN. Although, as a part of the EC it will use the
EMDN (European Nomenclature system for medical devices) too.
https://www.rijksoverheid.nl/ministeries/ministerie-van-volksgezondheid-welzijn-en-sport
https://www.igj.nl/
https://www.rivm.nl/medische-hulpmiddelen
http://www.igz.nl/english/medical_devices/
New Zealand
New Zealand uses a nomenclature based on the GMDN. The Global Medical Device Nomenclature (GMDN)
codes are required to identify types of medical devices notified to the WAND database.
https://www.medsafe.govt.nz/regulatory/DevicesNew/1Definition.asp
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Nicaragua

2021-2022
For various reasons there is not an official nomenclature system used for medical devices.

Nicaragua has its own nomenclature system based on the GMDN.
http://www.minsa.gob.ni/index.php/repository/Descargas-MINSA/Direcci%C3%B3n-General-de-
Regulaci%C3%B3n-Sanitaria/
Niger
2020
There are several types of codification tested. The first were inspired by the French CNEH code (national
code for hospital equipment). There is not a single codification adopted at the national level.
(Original in French) Il y a plusieurs types de codification testés. Les premières se sont inspirées du code
CNEH (code national pour l’équipement hospitalier) français. Il n’y a pas de codification unique retenue
au niveau national.
Nigeria
There is no official nomenclature system. Medical devices are regulated by the National Agency for
Food and Drug, Administration and Control (NAFDAC). Compliance with the classification of the country
where the device is manufactured (link 2).
https://www.nafdac.gov.ng/drugs/
https://www.sciencedirect.com/science/article/pii/S2211883718300303#tbl0010
https://www.nafdac.gov.ng/
North Macedonia
2020
The GMDN code is being recognized.

There is a nationally developed nomenclature but it is allowed the co-existence of several nomenclatures
such as GMDN.
https://lekovi.zdravstvo.gov.mk/medicaldevices
http://zdravstvo.gov.mk/wp-content/uploads/2012/12/zakon-za-lekovi-i-medicinski-pomagala.pdf
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Norway
2021-2022
The use of GMDN is not imposed by law.

Norway uses a nomenclature system based on the GMDN. However, as a part of the EC it will use the
EMDN (European Nomenclature system for medical devices) too.
https://legemiddelverket.no/English
Oman
The GMDN is used for regulatory purposes. However, UMDNS and GMDN are both accepted nomenclature
systems.
https://www.moh.gov.om/documents/16539/0/11%2B5++Listing+Guidance.pdf/9a6f51f7-b7b1-f209-2015-
b3fd56d37b2c
Panama
2020
The UMDNS system has been adopted into legislation. Its implementation is still in process.
(Original in Spanish) El sistema UMDNS ha sido adoptado en la legislación. Su implementación está aún
en proceso.
http://www.minsa.gob.pa/
http://minsa.b-cdn.net/sites/default/files/normatividad/decreto_468_de_2007_para_publicar_en_gaceta_2.
pdf
Panama is now in the process of adopting both the GMDN and the UMDNS for regulation purposes.
http://www.minsa.gob.pa/direccion/direccion-nacional-de-farmacia-y-drogas
Paraguay
2021-2022
A plan is being developed to proceed with the installation of a nomenclature system.
(Original in Spanish) Se está elaborando un plan para proceder con la instalación de un sistema de
nomenclatura.

The national regulatory authority is the Dirección de Vigilancia Sanitaria del Ministerio de Salud Pública
y Bienestar Social.
https://www.mspbs.gov.py/monitoreo-insumos-medicamentos.html
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Peru

2021-2022
Ley Nº29459-D.S and the D.S. Nº 016-2011-SA.
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Publicaciones/DocumentosConsulta/P08_234-
2017-05-04.PDF;
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Normatividad/2020/DS_036-2020-SA.pdf
According to the form DMEB-002 published on the official website, Peru uses the GMDN in the private
sector, although the use of UMDNS or other systems is legally accepted (Ley Nº29459-D.S and the D.S.
Nº 016-2011-SA). The national regulatory authority is the Dirección de Vigilancia Sanitaria del Ministerio
de Salud Pública y Bienestar Social. Advance Scientific del Perú.
http://www.digemid.minsa.gob.pe
Philippines
2020
The Philippines will be using the Nomenclature that will be decided by the member states of the ASEAN
who are working on the harmonization of medical device regulation in the region, where medical device
nomenclature is one of the concerns.

The national regulatory authority is the Bureau of Health Devices and Technology (BHDT), Department
of Health.
https://doh.gov.ph/node/266
Poland
2021-2022
2020
The GMDN code is mentioned as a basic medical device nomenclature system in Polish legislation: Act
of 20 May 2010 on Medical Devices; however, the use of other nomenclatures is allowed. Poland is part
of the EU medical device regulatory framework so a new obligation from the European Commission in
the area of medical device nomenclature and Eudamed will be implemented, e.g. adopting the European
Medical Device Nomenclature (EMDN) when available.
Nevertheless, according to the EC statement, this nomenclature will still share some features with the
GMDN code.
en.pdf
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In the private sector, Poland uses a nomenclature system of medical devices based on the GMDN. Although,
as part of the EC it will use the EMDN (European Nomenclature system for medical devices) too. The
national regulatory authority is the Office for Registration of Medicinal Products, Medical Devices, and
Biocidal Products.
http://www.urpl.gov.pl/en/office
en.pdf
Portugal
2021-2022
The Directorate-General of Health/Ministry of Health of this country pointed out that the official
nomenclature system for medical devices and IVDs for registry purposes is based on the European
Medical Device Nomenclature (EMDN).13
https://www.infarmed.pt/web/infarmed/pesquisa-dispositivos
In the private sector Portugal uses a nomenclature system of medical devices based on GMDN. Although,
as part of the EC it will use the EMDN (European Nomenclature system for medical devices) too. The
national regulatory authority is the National Authority of Medicines and Health Products (INFARMEDC,
IP).
https://www.infarmed.pt/
Qatar
2021-2022
This is used for planning medical equipment for new / upcoming projects.
https://www.ecri.org/solutions/umdns/
Medical devices are regulated by the MOHP but registered by the Ministry of Economy and Commerce
(MEC). It uses the UMDNS for planning for new/upcoming projects, but the GMDN is also accepted. The
national regulatory authority is the Medical Device Registration Unit, Pharmacy & Drug Control, Supreme
Council of Health.
https://www.mfds.go.kr/eng/index.do
Republic of Korea
Undefined nomenclature but uses medical devices classification and medical devices are regulated by
the Korean Food and Drug Administration (KFDA).
https://www.mfds.go.kr/eng/wpge/m_39/denofile.do
https://www.mfds.go.kr/eng/index.do
https://www.mfds.go.kr/eng/brd/m_61/view.do?seq=74
13 Answered to the September 2021 Survey for the GAMD 2021 Update
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Republic of Moldova

It uses its own developed nomenclature that, nevertheless, is harmonized with the EU’s regulation. The
nomenclature is based on the GMDN (as seen in the second link, second page point 3c) but the use of
other nomenclature is accepted too. The national regulatory authority is the agenţia medicamentului şi
dispozitivelor medicale.
http://nomenclator.amdm.gov.md
https://amdm.gov.md/ro
Romania
2021-2022

There is the European regulatory provision on medical devices Regulated by ANM (see first link) and a
national database of medical devices. There is also an own nomenclature system. Although, as part of the
EC it will use the EMDN (European Nomenclature system for medical devices) too.
https://www.anm.ro/en/
https://www.anm.ro/nomenclator-dm/
https://www.anm.ro/en/dispozitive-medicale/regulamentele-europene-privind-dispozitivele-medicale/
Russian Federation
There is an own developed nomenclature system but according to the fact that the state is a member of
the EEU, which signed an agreement with the GMDN about nomenclature systems harmonization. The
common market of medical products within the Eurasian Economic Union (EAEU) begins to function in
full in 2022.
https://roszdravnadzor.gov.ru/services/mi_reesetr
Rwanda
It uses the GMDN to register medical devices (see first link page 24).
http://www.rwandafda.gov.rw/web/guidelines/Guidelines_for_Regsitration_of_Medical_Devices.pdf
Via the “Questions for Biomedical / Clinical Engineers” survey, the Nabel HealthCare Engineering Ltd.
pointed out the main use of the Universal Medical Device Nomenclature System (UMDNS) for Rwanda’s
medical devices, as well as the coexistence of many nomenclatures for specific procedures. Also, it has
been expressed that even with the progress that this country has made in collaboration with the ECRI
Institute, there are major challenges caused by the many identification codes used for medical devices.14
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Regulated by the Central de Aprovisionamiento de Medicamentos:CAME (see link).
http://ms.gov.st/?p=57
Saudi Arabia
2021-2022
A committee inside NUPCO has been established for that purpose and the work is in progress.
http://www.nupco.com
Medical devices are regulated by the MOH (first link) via the unit NUPCO (second link) which manages
tenders for medical devices. Medical devices are Regulated by the Saudi Food and Drug Authority (third
link). Private industry uses the GMDN.
https://www.moh.gov.sa/
https://www.nupco.com/
https://udi.sfda.gov.sa
Senegal
Private industry uses the GMDN. The national regulatory authority is the Direction des Infrastructures,
d’équipement et de la Maintenance.
https://sante.sec.gouv.sn/les-directions/la-direction-des-infrastructures-des-equipements-et-de-la-
maintenance
Serbia
2020
National nomenclature is in the process of updating and amendment.
http://www.zdravlje.gov.rs
The national regulatory authority is the Medicines and Medical Devices Agency (ALIMS) which assures
the use of the official nomenclature.
https://www.zdravlje.gov.rs/tekst/335365/medicinska-sredstva.php
Sierra Leone
Medical devices are regulated by a national regulatory authority which is the Pharmacy Board (PBSL).
The GMDN is used for registration of medical devices, and it is regularly used by the private industry.
http://www.pharmacyboard.gov.sl/
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Singapore

2020
The Global Medical Device Nomenclature (GMDN) is used as an internal reference and it is not required
for medical device product registration

The GMDN is used for internal reference but not for the registration of medical products. In addition, since
the country is a member of ASEAN, other nomenclature systems are also used. The national regulatory
authority is the Health Science Authority.
https://www.hsa.gov.sg/medical-devices
Slovakia
2021-2022

Regulated by the MoH, it uses the SNOMED system. The national regulatory authority is the Ministry of
Health.
https://www.health.gov.sk/Titulka
Slovenia
2021-2022
2020
When medical devices are being produced by the manufacturers of medical devices with their registered
place of business in the Republic of Slovenia, are notified to the national competent authority, GMDN
code should be submitted, if available.
http://www.jazmp.si
https://simap.ted.europa.eu/cpv
No changes. The official information is regulated by the JAZMP. The private industry uses the GMDN. The
national regulatory authority is the Agency for Medicinal Products and Medical Devices of the Republic
of Slovenia.
https://www.jazmp.si/
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South Africa
2020
The regulator has adopted the use of GMDN which will be a nationally accepted nomenclature.

There are many co-existent nomenclatures. In many hospitals UMDNS is used. According to the country’s
legislature the GMDN can be used for special equipment, and IVDs (see first/second link). For medium
and high-risk devices, it is obligatory to use the GMDN for manufacturing, importing, exporting and
distribution (see first/second link). South Africa, for example, regulates medical devices according to
3 distinct pieces of legislation and guidelines most closely resembling those of the IMDRF founding
members (see link 3). The national regulatory authority is the South African Health Products Regulatory
Authority.
https://www.sahpra.org.za/wp-content/uploads/2019/09/20180201_SAHPRA-Registration_Medical-Devices_
Call-up-plan_v1.pdf
https://www.sahpra.org.za/wp-content/uploads/2020/01/Classification_Medical_Devices_IVDs_Nov19_v2.pdf
South Sudan
There is no official nomenclature system in South Sudan (first link 1st paragraph from the beginning of
page 6: The South Sudanese Drug and Food Control Authority Act, 2012). One of the nomenclatures
that may be used for the registration of medical devices is the one developed by US-FDA (second link:
registration requirement’s section).
https://www.wikiprocedure.com/index.php/Sudan_-_Registration_of_medical_device_and_In_Vitro_devices_
(IVDs)
Spain
2021-2022
2020
The code UMDNS has been used, but will be replaced by GMDN when the Spanish version is available.
(Original in Spanish) Se ha utilizado el código UMDNS, pero se sustituirá por GMDN cuando esté
disponible la versión en español.

It uses the UMDNS as the main nomenclature system. The GMDN is used for the regulation of medical
devices in the private sector. Both GMDN and UMDNS are proposed on the official website (AEMPS). Uses
the CIMA for medicine (see 2nd link). Regularly, private industry uses the GMDN system. The national
regulatory authority is the Agencia Española de medicamentos y productos sanitarios.
https://www.aemps.gob.es/
https://cima.aemps.es/cima/publico/home.html
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Sri Lanka

Medical devices are regulated by the National Medicines Regulatory Authority (NMRA).
https://nmra.gov.lk/index.php?lang=en
Sudan
It uses the UMDNS system, and since 2011 it has officially recommended the use of the GMDN. There is a
risk-based classification system (link 4).
https://fmoh.gov.sd/
https://fmoh.gov.sd/Health-policy/Sudan%20HTA&M%20Policy_final.pdf
https://fmoh.gov.sd/index.php/files/index/93

Medical devices are regulated by the MOH (see link). There is no specific information about the
nomenclature system used.
http://www.moh.gov.sy/
Sweden
2021-2022
2020
The change from GMDN to EMDN will take place with regards to the implementation of the new EU
regulation on medical devices that shall be applied from the 26th of May, 2021.

For medical substances registration use SNOMED CT
https://www.lakemedelsverket.se/en/e-tjanster-och-hjalpmedel/substans-och-produktregister/national-
substance-register-for-medicinal-products-nsl#hmainbody1
Switzerland
2020
Swissmedic uses GMDN (no country specific nomenclature); if manufacturers do not know the GMDN
number, a UMDNS code may be given.
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Both UMDNS and GMDN are used (the preference is given to GMDN, however, if manufacturers do not
know GMDN, then UMDNS is used). Currently, there is a transition to EMDN (based on CND), as well as
the corresponding mapping with the GMDN. The national regulatory authority is the Swiss Agency for
Therapeutic Products, Swissmedic.
https://www.bag.admin.ch/dam/bag/en/dokumente/biomed/forschung-am-menschen/mdr-eu-
berichterstattung/mdr-eu-berichterstattung-feb-20.pdf.download.pdf/20200217%20MDR%20IVDR%20
Reporting%20BAG%20February.pdf
https://www.bag.admin.ch/bag/en/home.html
Tajikistan
It uses the EAEU nomenclature, and the GMDN nomenclature, as well as others. The nomenclature of the
manufactured drugs and medical products is determined by the manufacturers themselves as the official
website states. The national regulatory authority is the Ministry of Health and Social Protection of the
Population of the Republic of Tajikistan.
https://portal.eaeunion.org/sites/odata/redesign/Pages/MedicalDeviceNomenclature.aspx
https://www.wipo.int/edocs/lexdocs/laws/ru/tj/tj036ru.pdf
Thailand
In Thailand, the sphere of medical devices is regulated by the Thai-FDA in cooperation with the Association
of Southeast Asian Nations (ASEAN) that works together with the AHWP Asian on the harmonization
of medical devices regulation. The GMDN is used for the regulation of medical devices in the private
industry.
https://www.fda.moph.go.th/sites/fda_en/SitePages/Medical.aspx?IDitem=index
https://asiaactual.com/blog/thailand-implements-new-medical-device-regulations/
Timor-Leste
There is an ongoing project for a nomenclature for MD, however there is scarce information.
http://timor-leste.gov.tl/?lang=en
Togo
2020
The level of the sub-service responsible for the equipment is too low to be read. The hierarchical superiors
do not show the necessary interest for the implementation of the management which is essential for
medical devices.
(Original in French): Le niveau du sous service chargé chargé des équipements est trop bas pour être
lisible. Les supérieurs hiérarchique ne portent pas l’intérêt nécessaire pour la mise en oeuvre de la gestion
qui s’impose pour les dispositifs médicaux.

https://www.wahooas.org/web-ooas/
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Trinidad and Tobago

2021-2022
Developed and in use as “Fixed Asset Inventory and Facilities Management”. TMA Systems Maintenance
Management Software (the nomenclature of medical devices are generally developed by the respective
Regional Health Authorities for procurement purposes).
Via the “Questions for Biomedical / Clinical Engineers” survey, the Ministry of Health of Trinidad and
Tobago has established that no specific or official nomenclature system is used in this country, but the
nomenclature codes given by manufacturers.15
Tunisia
2020
The nomenclature of medical devices is an integral part of the Manual of biomedical and hospital
maintenance management procedures drawn up in 1996 and improved in 2007 by the Ministry of Public
Health, which was the subject of an order.
(Original in French) La nomenclature des dispositifs médicaux fait partie intégrante du Manuel des
procédures de gestion de la maintenance biomédicale et hospitalière élaboré en 1996 et amélioré en
2007 par le Ministère de la santé publique qui a fait l’objet d’un arrêté.

It uses a nationally developed nomenclature system, as well as the GMDN for the regulation of medical
devices in the private sector.
http://www.dpm.tn/
Türkiye
2020
Huab (see second link) is the Turkish registry system for medical devices. Both GMDN and UNSPSC are
used in this system. For reimbursement purposes another nomenclature mentioned in the corresponding
link is also used.
https://www.saglik.gov.tr/?_Dil=2
http://www.huap.org.tr/ubb/
It uses a nomenclature system that is based on the UNSPSC and GMDN, however, they are adapted to
national needs. Türkiye y is in the process of using the EU regulation. The national regulatory authority is
the Turkish Medicines and Medical Devices Agency, Ministry of Health.
https://www.gs1.org/docs/healthcare/events/220610/8_Turkey_Goksin.pdf
https://www.ispartaeo.org.tr/haber-9
https://www.saglik.gov.tr/TR/
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Uganda
2021-2022
See the list of medical equipment by level, and the Standard Medical Equipment Lists and Specifications
by healthcare level are under review (as in sample formats in the corresponding websites). The main uses
of the nomenclature system are for procurement purposes, and inventory systems in healthcare facilities.
www.health.go.ug
There exists a regulatory framework for medical devices registration, importation and use (link 3).
However, Risk-based classification does not exist, and the application of the MD regulation is still limited
(link 4).
https://www.health.go.ug/download-attachment/ivZtalade9SPz4To_dbsBqwckPflb2S57yGgoi0lTo8
https://www.health.go.ug/download-attachment/wxVPCk1sDLk3NnNJiYkpYY-ohGwUXSeQMm7srliHbMM
https://www.nda.or.ug/medical-devices/#1603100276960-871cf845-bab3
Ukraine
2020
https://zakon.rada.gov.ua/rada/show/v0331282-01#Text
https://moz.gov.ua/article/ministry-mandates/nakaz-moz-ukraini-vid-28122019--2711-pro-zatverdzhennja-
nomenklaturi-likarskih-zasobiv-ta-medichnih-virobiv-scho-zakupovuvatimutsja-za-naprjamami-vikoristannja-
bjudzhetnih-koshtiv-u-2020-roci-za-bjudzhetnimi-programami-kpkvk-2301400
The incorporation of the GMDN is in progress. The national regulatory authority is the State Administration
of Ukraine on Medicinal Products (SMDC).
https://www.dls.gov.ua/en/state-service-of-ukraine-on-medicines-and-drugs-control/regulation/
United Kingdom of Great Britain and Northern Ireland

2021-2022
The Medicines and Healthcare products Regulatory Agency (MHRA) will be moving forward to use solely
the GMDN with their system being phased out. The nomenclature used by the National Health System
(NHS) for the procurement of medical devices is that used by the “Official Journal of the European
Union” (OJEU) CPV codes. The NHS also has a national system known as “e-class” which is a classification
system for products and services.
http://www.mhra.gov.uk/Howweregulate/Devices/Registrationofmedicaldevices/index.htm
www.nhseclass.nhs.uk
The MHRA will be moving forward to solely use the GMDN with its previous system being phased out.
The nomenclature used by the NHS is for the procurement of medical devices that are used by the
“Official Journal of the European Union” (OJEU) CPV codes. Also, the NHS has a national system known
as “e-class” which is a classification system for products and services. The national regulatory authority
is the Medicines & Healthcare products Regulatory Agency (MHRA).
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#history
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/949074/
Device_Registration_Reference_Guide_January_2021_Migrated_and_Re-registered_and_New_accounts_
Final_v1.pdf
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

2020
TMDA is using GMDN as the nomenclature system for the registration of medical devices in Tanzania. The
main types of nomenclature used are GMDN and UMDNS. The main uses of the nomenclature system are
for procurement purposes and inventory systems in healthcare facilities.
http://www.gmdnagency.org
It has been used by the GMDN since 2015, but there is no access to the nomenclature code from the
official website. It is obligatory to use a nomenclature system as it has been stated in the guidelines for
the registration of medical devices.
https://www.tmda.go.tz/publications/24

There is a nationally developed nomenclature but it is allowed the co-existence of several nomenclatures
(often suggested by the importer -see first two links-). Regulated by the MOH (see links).
https://www.mohap.gov.ae/Files/MOH_OpenData/562/MoH-UAE-Registred-MD-2-2-2014.pdf
https://www.mohap.gov.ae/Files/MOH_Service/373/09%20Classification%20of%20a%20ProductEN.pdf
https://www.mohap.gov.ae/en/services/issuing-a-permission-to-import-medical-equipment

2021-2022
1. Product Code. FDA- The Center for Devices and Radiological Health (CDRH) uses a nomenclature by
assigning a 3-letter code to identify a device into a generic type or category. This nomenclature system
is known as product code classification. The short name is ProCode. The Product Code Classification
Database contains medical device names and associated information developed by the CDRH in support
of its mission. This database contains device names and their associated product codes. The name and
product code identify the generic category of a device for the FDA. The Product Code assigned to a device
is based upon the medical device product classification designated under 21 Code of Federal Regulations
(CFR) Parts 862-892.2. Problem code FDA-CDRH also has a nomenclature for CDRH Event Problem
Codes for Medical Devices used in reporting adverse device events. The adverse event vocabulary codes
were developed in cooperation with the National Cancer Institute Enterprise Vocabulary Service (NCI-
EVS); see the second link.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051637.
htm
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/EventProblemCodes/default.htm
https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database
Via the “Questions for Biomedical / Clinical Engineers” survey, the U.S. Food and Drug Administration
has specified that, besides their product codes for medical device classification, the Global Medical
Devices Nomenclature (GMDN) is the official nomenclature used in the UDI system and for all medical
device requirements in this country.16
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Uruguay
UMDN is commonly used in the Mercosur bloc.
https://www.gub.uy/ministerio-salud-publica/home
Uzbekistan
It uses its own nomenclature system (see first link). Used nomenclature correlates with one used by the
EU (second link).
https://data.gov.uz/uz/datasets/3514?dp-1-sort=G1

2021-2022
Does not have one specific nomenclature. For the certification of the medical device, the nomenclature
used is the U.S FDA product classification.
https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database
Via the “Questions for Biomedical / Clinical Engineers” survey, the Simon Bolivar University informed that
it has defined the U.S. Food and Drug Administration product codes as the official nomenclature system
used for medical devices in this country. Also, this institution has developed the “Quality Certification
Process for Medical Equipment”, which has been authorized by the Ministry of Health of Venezuela.17
https://www.legiscomex.com/BancoMedios/Documentos%20PDF/res_614.pdf
Yemen
Regulated by the Supreme Board for Medicines & Medical Appliances (SBDMA)/ MoPHP.
www.sbd-ye.org
Zambia
Regulated by the Zambia Medicines Regulatory Authority (ZAMRA).
https://www.zamra.co.zm
Zimbabwe
Regulated by the Medicines Control Authority of Zimbabwe (MCAZ).
https://www.mcaz.co.zw
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Conclusion
As presented in this report, there are various nomenclature systems (EMDN, GMDN, nationally developed,
and UMDNS) used around the world for different purposes. Nevertheless, less than one-half of the world
does not have an official nomenclature to manage medical devices, and more than half have at least one
of the four types mentioned above. This situation has been continuously evolving in the past ten years,
with promising signals of more countries acquiring an official nomenclature and also signals of multiple
nomenclatures being used for different purposes around the world. Several efforts are currently in place
to harmonize not only the heterogeneous regulatory framework worldwide, but more specifically a
international nomenclature system. Until now, these efforts have not been achieved due mainly to a lack
of agreement between the main stakeholders and member states. As indicated before, the nomenclature
system of medical devices is a cross-cutting issue that interrelates the national health system with other
areas such as the economy, commerce, and health service provision within a country as well as with other
countries due to globalization and regional agreements between countries.
However, we observe a positive trend of countries strengthening their regulatory frameworks, harmonizing
their procedures, and adopting an official medical device nomenclature. To the extent that the health
system is strengthened, it will facilitate the provision of services to achieve faster a universal health
coverage.
Other limitations: More often than not, several regulations and agreements may be in use in a country
for different purposes but also for a single purpose. For instance, it is possible to have more than one
agreement regarding imports and exports depending on the destination or origin of merchandise. As a
consequence, sometimes there may be more than one answer to the questions we ask.
It is a milestone achivement that the World health assembly approved In May 2022, the co-existance of
various nomenclature systems in WHO platforms for reference to be available, accessible to all Member
States, towards standardization.
Acknowledgements
This overview was commissioned by WHO and conducted by Ricardo X. Martinez Martinez, Lucero López
Pérez, Lucía Jiménez Martínez, Juan J. López Pérez, Artem A. Shchepilov, Sebastián Losada Espinosa,
David López Pérez. Many thanks to Eunice Lourenço Nobre da Conceição for her valuable comments
and additions.
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References
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Enríquez, Nilda, et al. “Situación de la regulación de los dispositivos médicos en la Región de las
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Matthies, Claudia. Regulatory requirements of Medical Devices in Southeast Asia and China. Bonn:
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World Health Organization

Medical Devices Unit
20 Avenue Appia
1211 Geneva 27
Switzerland
medicaldevices@who.int
https://www.who.int/health-topics/medical-devices

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Ecuador - - - - - - - 106 Kenya - - - - - - - 180

Niue - - - - - - - - 254 Spain - - - - - - - 328

Acronyms and abbreviations

FY21 Fiscal Year 2021

EMDN European Medical Device Nomenclature

GII Global Innovation Index

GNI gross national income

GHO WHO Global Health Observatory

GMDN Global Medical Device Nomenclature

HDI Human Development Index

HTA health technology assessment

IAEA International Atomic Energy Agency

ICT information, and communication technology

IDI ICT Development Index

ITU International Telecommunication Union

IHDI inequality adjusted Human Development Index

IVDs in vitro diagnostics

MOH Ministry of Health

NCDs noncommunicable diseases

OECD Organisation for Economic Co-operation and Development

SDGs Sustainable Development Goals

UHC Universal Health Coverage

UMDNS Universal Medical Device Nomenclature System

WHO World Health Organization

WHS World Health Statistics

WIPO World Intellectual Property Organization

WPP World Population Prospects

Sources of the country profile’s

Country indicators section

C3D4 Medical device nomenclature system section

Medical equipment section

Medical devices workforce section

Country indicators - WHO country information

Index (inequality 0.51 (—): Global innovation

National policy on health technology

National lists of medical devices

National regulatory authority National regulatory comments

Medical device incorporation

Computerized Tomography Scanner:α 6 0.2

Positron Emission Tomography Scanner:α 0 0

Gamma camera or nuclear medicine:α 0 0

Medical equipment management unit

Medical devices workforce

Country indicators - WHO country information

Index (inequality 0.8 (0.71): Global innovation

National policy on health technology

National lists of medical devices

National regulatory authority National regulatory comments

Medical device incorporation

Computerized Tomography Scanner:α 17 5.36

Positron Emission Tomography Scanner:α 0 0

Gamma camera or nuclear medicine:α 0 0

Medical equipment management unit

Number of biomedical/clinical engineers professionals in the country:γ 55

Country indicators - WHO country information

Index (inequality 0.75 (0.6): Global innovation