TOPIC: ISO 13485

ABHINANDAN SHARMA
DR. AMANDEEP SINGH
INSTITUTE: IIT KANPUR
AEROSPACE ENGINEERING
DATE: 25 MARCH 2022
ISO 13485 PRACTICES IN INDIA
ISO: International Organisation for Standardisation. Quality Management
System designs and manufacture medical devices.
INTRODUCTION:
According to ISO 13485:2016, some rules and guidelines were issued by the
government for the import of medical devices. The Central Drugs Standard
Control Organization (CDSCO) under the Ministry of Health & Family Welfare
(MoHFW), Government of India issued a draft of Medical Devices Rules, 2017
through a gazette notification published on October 17, 2017. These regulations
focus on the safety and quality to ensure high standards assurance of a medical
device.
Indian subcontinent is the second largest in the world for its population and
fourth largest in Asia for its medical device market valued at 5.5 billion dollars
the major stake of the device market 70 % as per reports has come through
imports. Previously medical devise in India were regulated as drugs under
Drugs Cosmetics Act 1940 and Rules, 1945 but in recent years the local
authorities Central Drug Standard Control Organisation see the SCO has
devised separate regulations naming them as New Medical Device Rules, 2017
which have come into force from 1st January 2018 in the face of new rules what
one needs to look into is to gain a comprehensive knowledge on the new
regulatory.
The new structure for medical devices in India comprises of 12 chapters with 97
rules 8 schedules and 40 forms which spread out over 108 pages all together.
When compared to previous device rules there are some notable changes in the
new rules proposed.
Some of them include:
Risk based classification of devices in India: the old 3 years validity is replaced
by a perpetual license by paying license retention fee every five years inclusion
of notified bodies for inspection of domestic manufacturers
provision for establishing new testing laboratories. extension of test license
validity for 1 to 3 years the authority is also planning to implement unique
device identification for medical devices and in-vitro diagnostic devices.
As a significant improvement India with the new device regulations is all set to
adopt the risk-based classification for the first time. The CDSCO has also
expanded the previous list of devices from 22 to 598. the devices in India based
on their risk level can now be classified into 4 classes.

ROLES OF CDSCO:
 Approval of new drugs and clinical trials.
 Import CDSCO registration & licensing.
 Licensing of blood banks, vaccines and some medical devices.
 Amendment to Drugs & Cosmetics act and rules.
 Participation in WHO GMP certification schemes.
 Grant to test licenses, NOC’s for export.
 Testing of drugs by central labs.
Step wise medical device registration and CDSCO guidelines for India:
1. Check the product with list of notified medical devices and IVDs.
2. Firstly appoint an Indian authorized agent to interact with the Central
Drugs Standard Control Organization (CDSCO).
3. India authorized agent powe of attorney to manage your registration in
India.
4. Using Form 40 schedules D-1 and D-2 must be included as well as
verification of compliance with US, Canadian, European, Japanese or
Australian medical device regulations.
5. Require a Form 45 (New Drug License) in support of the form 40
application.
6. Obtain registration certificate Form 41 CDSCO.
7. Identify your distributor in India (holding forms 20B and 21B).
8. Apply for import license using Form 8 and 9 available from CDSCO.
9. Obtain import license (Form 10) from CDSCO.
 10.You are now authorized to market your device in India.
CLASSIFICATION OF MEDICAL DEVICES IN ISO 13485 IN INDIA:
Class A: Low includes thermometers and sphygmomanometer
Class B: Low-Moderate includes needles and suction cannula
Class C: Moderate-High includes ventilator and joint implants
Class D: High includes pace maker and heart valves
Low category includes equipment such as thermometer while High category
includes pacemakers, heart valves etc. License for category A is easier to obtain
as compared to category D.
The license for the Class A & B are issued by STATE LICENSING
AUTHORITY (State Drugs Controller). It will be entitle for all the norms
regarding the sales, manufacturer, stock and other practice. Medical devices
which are under class A need not to be licensed.
The Class C & D license are issued by CENTRAL LICENSING AUTHORITY
for the import and manufacture of Class C & D products. The importing
authorities still lies with the central licensing authorities.
 CDSCO urged all the manufacturers and importers of non-notified
devices to obtain Voluntary Registration Number by 30th September
2021.
 Post 30th September 2021 mandatory registration of devices shall be
applicable based on the risk classification.
For Class A & B mandatory registration shall be valid till 30th September
2022.
For Class C&D mandatory registration shall be valid till 30th September
2023.
 Post these timelines corresponding devices shall be regulated.
Consequently, import license shall be mandatory to import the same.
Also, Medical Devices Rules 2017 deems a medical device license acquired as
perpetually valid every five years.
A clinical investigation framework has been introduced, for greater efficiency.
The medical devices rules, 2017 also brought changes in some fundamental
forms. Form MD-14 enables an authority agent to apply for the grant of an
import license for medical devices and in-vitro devices on behalf of the
manufacturer. The import license shall be obtain in Form MD-15. Form MD-26
is the application for the import or manufacturer of medical device that doesnot
have a predicate or any similar medical device in the Indian market, whereas the
permission granted to import medical device on form MD-27.
For medical devices and IVD import licenses, organizations outside India
require an Indian authorized agent possessing a wholesale license for sale or
distribution. This agent could be an organisation like CliniExperts with
extensive experience in the field, holding a valid wholesaler license as per the
Forms 20B and 21B of the act. CliniExpert is an authorized agent for overseas
manufacturers to overlook the import process along with excellent consultant
services. CliniExperts has been in business for years and offers a wide range of
services, including regulatory consulting services and import assistance.
IMPORT OF MEDICAL DEVICES IN INDIAN MARKET:
Step 1: You have to classify your medical devices and they are classified as
Class A, B, C & D.
Step 2: Appointment of an Indian authorized agent with valid manufacturing or
wholesale license. “Authorized agent” means a person including any firm or
organization who has been appointed by an overseas manufacturer through a
power of attorney to undertake import of medical device in India.
There are two scenarios that are required for clinical investigation.
Case I: If you have free sale certificate already assigned by recognized
regulatory authorities; European Union, United States, Japan, Australia, Canada
then the import license shall be granted to the applicant without carrying out
clinical investigation in India.
Case II: If medical device is imported in country other than mentioned.
For Class A& B: The license will be granted only after its safety and
performance data through already published documents or clinical investigation
in country of origin.
For Class C&D: The safety and effectiveness has to established through clinical
investigation in India.
Step 3: Registration your organization on Online CDSCO portal: Online System
For Medical Devices.
Step 4: Documents required for grant of license of manufacture for sale or for
distribution or import
1. Power of attorney
2. Undertaking from authorized agent
3. Notarized copy of overseas manufacturing site and Free sale certificate
issued by the National Regulatory Authority of the country concerned.
4. Notarized copy of Quality Management System Certificate issued by the
competent authority.
5. Authorized agent self attested copy of valid whole sale license issued by
CDSCO.
6. Copy of latest inspection or audit report carried out by Notified bodies or
National Regulatory Authority within last 3 years.
7. Constitution details of domestic manufacturer or authorized agent
8. Site or plant master file
9. Device master file
10.Essential principles checklist for demonstrating conformity to the
essential principles of safety and performance of the medical device
including In vitro diagnostic medical device
11.Undertaking signed stating that the manufacturing site is in compliance
with the provisions of the fifth schedule of Indian MDR.
12.Copy of ISO 13485 certificate
13.Copy of CE certificate
14.Copy of IFU
15.Clinical investigation report
16.Free sale certificate
Submit application in Form-MD 14
Step 5: Examination of documents by CDSCO
Step 6: CDSCO will issue Import License Form MD-15
In a nutshell as the new rules have already come into effect from 1st January
2018 it is required that device manufacturers who are willing to enter the region
have a comprehensive understanding of them.
 ISO 13485:2016 PRACTICES IN CANADA
INTRODUCTION
Implement an ISO 13485:2016 for all devices (except Class I) under the
medical device single-audit program (MDSAP) compliant quality management
system that includes CMDR specific requirements and audited by an
organization under the MDSAP.
Class I devices will require application for a medical device establishment
license (MDEL).
An application for a Canadian medical device license (MDL) is required for
Class II, III and IV devices.
For Class I devices, submit MDEL application, prepare required procedures pay
Health Canada fees.
For Class II devices submit MDL application, fee form, labeling, declaration of
conformity and ISO 13485 Certificate.
For Class III and IV devices submit MDL application plus declaration of
conformity, ISO 13485 (MDSAP) certificate, fee form, labeling (IFU) and
premarket review document following the IMDRF TOC format that may
include the requirement for Class III and IV devices.
Class I devices Approved applications will be posted on Health Canada's
website and your MDEL certificate will be emailed to you.
Class II, III & IV devices issued licenses will be posted on Health Canada’s
website and copies of your MDL will be emailed to you. Aq
Licensing rules for medical devices in Canada for manufacturers, distributors
and importers of medical devices.
The governing bodies for medical devices in Canada is Health Canada. Health
Canada is responsible for regulating the sale, advertising and importing for sale
of medical devices in the country. Health Canada regulates manufacturers,
distributors and importers. It also regulates the licensing processes for these
three groups of stakeholders.
 MEDICAL DEVICES DIRECTORATE
Director General's Office:
 Communicate with Stakeholders in Canada and around the world.
 Overseas and directs directorate's vision and priorities.
Bureau Of Licensing Services:
 Regulatory processing of medical device license applications.
 Managing stakeholders enquiries in regards to medical devices
classification.
Bureau Of Investigational Testing Authorization, Special Access Program And
Post-market Surveillance:
 Authorize sale of devices for use in clinical studies on humans.
 Provide expedited access to specific unlicensed medical devices.
 Post-market monitoring of authorized medical devices.
Bureau Of Evaluation:
 Scientific review of license applications for various types of devices.
 Digital health, in-vitro diagnostic, cardiovascular, musculoskeletal and
general restorative devices.
Bureau Of Planning And Operations:
 Provide strategic planning and financial management for the directorate.
 Manage stakeholders meeting.
 Manage QMS program.
Bureau Of Policy And International Programs:
 Manage international files.
 Develop and implement guidance documents and policies.
 Support the engagement of external experts.
CLASSIFICATION OF MEDICAL DEVICES ISO 13485 IN CANADA
 Medical devices:
Class I: Band-aids, compression, non-invasive
Class II: Condoms, invasive, blood pressure monitors
Class III: Laser devices, blood touching, implants
Class IV: human Tissues, active implantables
 In Vitro-Diagnostics:
Class I: microbiology tests, everything else
Class II: patient management, moderate level diagnostics
Class III: sexually transmitted diseases, moderate to high level
Class IV: death or serious injury diseases, detecting high level diagnostics.
Health Canada divides medical devices into 4 categories Class I, Class II, Class
III and Class IV based on risk and safety using a set of 16 rules found in
Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR). In-
vitro diagnostic devices have a slightly different classification but they still have
these 4 Classes and they also fall under the same regulations when it comes to
sale, advertising and importing. In Class I, II, III&IV devices require a product
specific Canadian Medical Device License (MDL) and ISO 13485:2003 or ISO
13485:2016 certification. Class I products require a Medical Device
Establishment License (MDEL), which is held by the manufacturer or
distributor.
LICENSING OF MEDICAL DEVICES IN CANADA:
Manufacturers of Class I devices in Canada must apply for a Medical Device
Establishment License (MDEL) unless they solely import or distribute though a
licensed distributor/importer. The MDEL is not a device specific license, but
rather it applies to the applicant and their company; one MDEL is sufficient per
manufacturer and may cover a range of Class I devices
Manufacturers of Class II, III, and IV products will require a Medical Device
License (MDL) application to Health Canada for review and approval. MDLs
are specific to the device/device family, with separate MDLs submitted for
separate devices or device families.
ISO 13485:2003 or 2016 is mandatory for all Classes II-IV devices. In addition,
the manufacturer must have CMDCAS (Canadian Medical Device Conformity
Assessment Systems) embedded into their ISO 13485 quality management
system (QMS), and the QMS must be audited and certified by an ISO registrar
that is recognized by Health Canada.
However, Health Canada is participating in the Medical Device Single Audit
Program (MDSAP). In accordance with Health Canada's announced MDSAP
transition plan, CMDCAS certificates will no longer be accepted after 31
December 2018. Manufacturers will be required to submit valid MDSAP
certificates no later than 01 January 2019 to maintain their MDL.

Manufacturers that wish to commercialise their devices in Canada. They need to

receive the authorization from Health Canada and that authorization will depend
on the class of medical devices. For medical devices Class 2,3&4 manufacturers
will have to register their devices individually or by a group depending on what
kind of devices they are selling. With Health Canada in order to obtain Medical
Device License (MDL) which will grant the permission to sell those devices in
Canada. All rules and regulations are outlined in Food and Drugs Act and
medical devices regulations.
For Class 1 Medical devices manufacturers need to register the company with
Health Canada in order to obtain a Medical Device Establishment License
(MDEL) which also allows to sell in Canada. If the device is being sold through
a distributor or importer who holds MDL already manufacturers do not need to
register them they can use the existing MDL for imports and commercialization
and market entry.
DOCUMENTS REQUIRED FOR LICENSING MEDICAL DEVICES IN
CANADA:
Now in higher risk medical devices Class 2,3&4 manufacturers will have to
register them and submit some paperwork to Health Canada in order to obtain
MDL.
For Class 2 Medical devices there are only 4 major forms that need to be
submitted to Health Canada.
1. Application form
2. Fee form
3. Quality management system certificate
4. Labelling
For Class 3 & 4 manufacturers will have to submit 5 forms
1. Application form
2. Fee form
 3. Quality management system certificate
4. Labeling
5. Premarket review ( this contain information about safety of the device in
that manufacturer is following recognized standards for manufacturing
and healthcare in general.)
Medical devices Class 2,3&4 are required to obtain MDL prior their importation
to Canada.
TYPES OF APPLICATIONS FOR MEDICAL DEVICES:
When applying to medical device licensing manufacturers need to be aware of
six different application types
1. Medical device family
2. Medical device group
3. Medical device group family
4. Test kit
5. System
6. Single medical device
Since 1st January 2019 Health Canada also require a copy of valid MDSAP
(Medical Device Single Audit Program) certificate from manufacturers that are
trying to register their medical devices with Health Canada. MDSAP needs to
be done by the manufacturer it’s a single process for the audit of the
manufacturing process and Health Canada pays attention to it now and will
request it from you if you apply for license to sell and bring products to Canada.
SUMMARY:
In Canada, Health Canada is a regulatory body for all medical devices. If
someone wish to become distributor, importer or manufacturers of medical
devices they need to be aware what class of medical devices their products are
falling in and based in that they will make decisions and make the applications.
If it’s Class 1 all they need is MDEL. If its Class 2,3&4 they will have to apply
for medical devices license which is MDL. Its little bit longer process, more
complex but that will allow them to sell and import in Canada. They will need
to submit 4 documents for Class 2 and 5 documents for Class 3&4 for the
application process and they need to be aware of six types of applications that
are existent in Canada depending on the devices and they need to choose which
one your product is falling in.