2019

CSDT
Common Submission
Dossier Template
General Medical Device
 Overview OF CSDT
• Reference Doc – MDA/GD/0008 – 1st Edition.
• Should be prepared by a manufacturer as a
summary of the technical documentation of
the medical device.
• Must contain all elements of CSDT as specified
in Appendix 2 of third Schedule of Medical
Device Regulation 2012.
• Should be in English or Bahasa Malaysia
• The information contained in the CSDT should
be supported by relevant supporting
documents for example copies of labels,
certificates and reports.
 Element Of CSDT

Executive Summary 01
05 Device Labelling
Essential Principal
02
Conformity Checklist (EPSP)
06 Risk Analysis
Device Description 03

Summary of Design
Verification & Validation 04 07 Manufacturer Information
Documentations
1. Executive Summary
.
1.1. Device Overview
• Introduction to the device.
• Describe the device on how the device work.

1.2. Commercial Marketing History

Please state all the countries that the device have been marketed into, including GHTF and non GHTF.

Example:

Country Date of Introduction No of Adverse Event Occurred

German March 2014 24
Japan June 2016 None

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1.3. Intended Use and Indication
• based on Label/Instruction for Use (IFU).

1.4. List of Regulatory Approval

Reference Agency Intended Use Indications of Use Registration Status Reasons for
Rejection and
Withdrawal
US FDA Can be different or identical Approved, pending, State the reasons
Health Canada rejected, withdraw for applicable status
or not applicable
Australia TGA
EU Notified Body
Japan MHLW

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2. Essential Principle Conformity
Checklist (EPSP)
.
 EPSP
➢ References Documents:
MDA/GD/0007: The Essential Principles of Safety and
Performance of Medical Devices

➢ Determine all the relevant essential principles that are

applicable

➢ Include compliance with recognized or other standards,

➢ Specific document shall be reference in the elements of CSDT

➢ Usually documented in checklist format

NO.
Example of EPSP Checklist
ESSENTIAL PRINCIPLES APPLICABLE TO THE APPLICABLE IDENTITY OF SPECIFIC
DEVICE INTERNATIONAL DOCUMENTS
STANDARDS
1.0 Medical devices should be designed YES ISO 13485: 2012 Technical Documents
and manufactured in such a way that, Quality Management (Product Design File
when used under the conditions and
Systems- Medical XXXX)
for the purposes intended and, where
Devices Annex 5
applicable, by virtue of the technical
knowledge, experience, education or
training of intended users, they will
not compromise the clinical condition ISO 14971: 2012 Risk Management
or the safety of patients, or the safety Medical Devices - Report Annex 12
and health of users or, where
applicable, other persons, provided Application of Risk
that any risks which may be management to
associated with their use constitute medical devices
acceptable risks when weighed
against the benefits to the patient and
are compatible with a high level of
protection of health and safety.

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 EPSP
General
Principle

Content Of
EPSP

Design and
Manufacturing
Principle
 EPSP
➢General Principles – Mostly are related with manufacturing
process that comply with quality management system and risk
management process. Example :
❖Devices shall achieve the performance intended by the
manufacturer and be designed, manufactured and packaged in such
a way that they are suitable for one or more of the functions within
the scope of the definition of a medical device applicable in each
jurisdiction.
❖The devices shall be designed, manufactured and packed in such a
way that their characteristics and performances during their
intended use will not be adversely affected under transport and
storage conditions (for example, fluctuations of temperature and
humidity) taking account of the instructions and information provided
by the manufacturer.
❖The benefits must be determined to outweigh any undesirable side
effects for the performances intended.
 EPSP
➢11 Design and Manufacturing Principles
1. Chemical, physical and biological properties
❖ Example: Implant system, Catheter, IVF fertilization medium
❖ ISO 10993-1: 2018 Biological evaluation of medical devices
❖ ISO 14607:2018 Non-active surgical implants -- Mammary implants
❖ ISO 13408-1:2008 Aseptic Processing of Health Care Products

2. Infection and microbial contamination

❖ Example: Device Supplied in sterile condition
❖ ISO 11138-1:2017 - Sterilization of health care products
❖ ISO 11607-1:2019 Packaging for terminally sterilized medical devices
❖ ISO 11135 Sterilization of Health-Care Products -- Ethylene oxide --
Requirements for the Development, Validation and Routine Control of a
Sterilization Process for Medical Devices
❖ ISO 11137 Sterilization of Health Care Products -- Radiation
 EPSP
➢11 Design and Manufacturing Principles
3. Manufacturing and environmental properties
❖ Example : CT Scan, X-ray system
❖ IEC 60601-1-1 : Medical Electrical Equipment
❖ Environmental test, i.e. power fluctuation test, temperature and
humidity test.

4. Device with a diagnostic or measuring function

❖ Example: Blood Pressure Monitor, Patient Monitor
❖ IEC 60601-2-34:2011
❖ IEC 80601-2-30:2018
❖ IEC 62304:2006 - Medical device software

5. Protection against radiation

❖ Example: X-ray system
❖ IEC 60601-1-3:2008/AMD1:2013 Collateral Standard: Radiation
protection in diagnostic X-ray equipment
 EPSP
➢11 Design and Manufacturing Principles
6. Requirements for medical devices connected to or equipped with
an energy source.
❖ Example: Defibrillator, Ventilator
❖ IEC 60601-2-34:2011
❖ IEC 62304:2006 - Medical device software

7. Protection against mechanical risks

❖ Example : Electrosurgical system

8. Protection against the risks posed to the patient by supplied energy

or substances.
❖ Example: Syringe pump, Infusion Pump, Feeding Pump

9. Protection against the risks posed to the patient for devices or self-
testing or self-administration.
 EPSP
➢11 Design and Manufacturing Principles
10. Information supplied by manufacturer.
❖ Example: Product Labelling/IFU
❖ ISO 15223-1:2016 Medical devices -- Symbols to be used with
medical device labels, labelling and information to be supplied

11. Performance evaluation including where appropriates, clinical

evaluation.
❖ Clinical evaluation reports.
❖ ISO 14155:2011 - Clinical investigation of medical devices for
human subjects - Good clinical practice
 EPSP
➢Sample of standard that related with medical device:

❖ ISO 14971 Medical Devices – Application of Risk Management to Medical Devices

❖ ISO 13485 Medical Devices – Quality Management Systems – Requirements for
❖ Regulatory Purposes
❖ ISO 11135 Sterilization of Health-Care Products -- Ethylene oxide -- Requirements for the
Development, Validation and Routine Control of a Sterilization Process for Medical Devices
❖ ISO 11137 Sterilization of Health Care Products -- Radiation
❖ ISO 11138 Sterilization of Health Care Products -- Biological indicators ISO 11140 Sterilization of
Health Care Products -- Chemical indicators.
❖ ISO 11737 Sterilization of Medical Devices -- Microbiological Methods
❖ ISO 17665 Sterilization of Health Care Products - Moist Heat
❖ ISO 14937 Sterilization of Health Care Products - General Requirements for Characterization of a
Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for
Medical Devices
❖ ISO 13408 Aseptic Processing of Health Care Products
❖ ISO 10993 Biological Evaluation of Medical Devices
❖ ISO 23640 In Vitro Diagnostic Medical Devices - Evaluation of stability of in vitro diagnostic reagents
 EPSP
➢Sample of standard that related with medical device :

❖ ISO 14155 Clinical Investigation of Medical Devices for Human Subjects - Good clinical practice
❖ ISO 14644 Cleanrooms and Associated Controlled Environments
❖ ISO 17664 Processing of Health Care Products - Information to be Provided by the Medical Device
Manufacturer for the Processing of Medical Devices
❖ ISO 80369 Small-Bore Connectors for Liquids and Gases in Healthcare Applications
❖ ISO 22442 Medical Devices Utilizing Animal Tissues and their Derivatives
❖ IEC 60601 Medical Electrical Equipment
❖ IEC 61010 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory
Use
❖ IEC 62366-1 Medical Devices - Part 1: Application of Usability Engineering to Medical Devices
❖ IEC 62366-2 Medical Devices - Part 2: Guidance on the Application of Usability Engineering to
Medical Devices
❖ IEC 80001 Application of Risk Management for IT Networks Incorporating Medical Devices
❖ IEC 62304 Medical device software - Software Life Cycle Processes
3. Device Description
.
3.1. Description of the Medical Device

• Provide details description of the device.

• Specify and clarify on. the important components.
• Explain on how the device will achieve its intended used – principle
of operation or mode of action.
3.2. Risk Class and Classification Rule
• State the device rule and class according to Malaysian Regulation.
May citing any reference clause from GHTF agency.

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3.4. Description of Accessories

• Provide list of accessories supplied with the device.

• State clarification if needed.

3.5. List of Configurations

• List out all the items on the product grouping

• Can be refer to the excel file of product grouping

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3.6. Novel Features
• Specific for device that have new and different features with other
device.
• Clinical test is compulsory to validate the device performance and
safety.

3.7. Intended Use, Indications, Instruction for Use,

Contraindications, Warning, Precaution and Potential Adverse
Effect
• Refer to IFU

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3.8. Alternative Therapy

• Any other alternative or device that will have the same intended
purpose.
3.9. Materials
• List out all the materials of the device.
• Compulsory for device that can give effect to the patient body

3.10. Other Relevant Specifications and Descriptive Information

• Refer to brochure.

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4. Summary Of Design Verification &
Validation Documentation.
.
4.1. Pre-clinical Studies
A stage of research/test before clinical trials/test. Usually focus on the
safety of the product.

i. Biocompatibility Test
ii. Pre- Clinical Physical Test
iii. Pre- Clinical Animal Studies

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 Pre-clinical Test
Biocompatibility Test
➢ For medical devices that directly or indirectly contact patients, biocompatibility testing is
required to obtain regulatory approval in most markets. Biocompatibility tests help determine
whether a device performs as intended without causing any adverse or harmful effects for
patients or users, and mitigate any biological risks posed by the device.
➢ ISO 10993 – Biological Evaluation of medical device
➢ Primary test category a shown below:

Acute systemic toxicity testing Biodegradation testing

Carcinogenicity testing Chronic toxicity testing
Cytotoxicity testing Genotoxicity testing
Hemocompatibility testing Implantation testing
Intracutaneous irritation testing Reproductive/developmental testing
Sensitization testing Subchronic toxicity testing
20
 Pre-clinical test
Pre-clinical Physical Test
Mechanical Tests (ASTM's physical and mechanical testing)
Electrical Safety Tests (IEC 60601)
Accelerated Aging Test (ASTM F1980 and ISO 11607)
Pre- Clinical Animal Studies
The studies should address the interactions between
the device and the animal fluids/tissue and the
effectiveness of the device in the experimental
animal model.
4.2. Software Validation Studies (IEC 62304)
• Ensure correctness and precision of the software
• Validates the software design and development process
• Include the results of all verification, validation and testing
performance in house and in user’s prior to final release

4.3. Medical Device Containing Biological Material (ISO 22442)

• Consist list of materials
• Information of selection sources / donors
• Information of process from input to output
• Allow traceability

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4.4 Clinical Evidence
This section should indicate how any applicable requirements of the Essential Principles for clinical
evaluation of the device have been met. Where applicable, this evaluation may take the form of
(a) a systematic review of existing bibliography,
‘A review of a clearly formulated question that uses systematic and explicit methods to identify,
select, and critically appraise relevant research, and to collect and analyse data from the studies
that are included in the review. Statistical methods (meta-analysis) may or may not be used to
analyse and summarise the results of the included studies’ (Cochrane Collaboration, 2014)
(b) clinical experience with the same or similar devices, or
-Demonstrate the equivalence. Similar means that no clinically significant difference in the
performance and safety of the device would be due to differences;
(c) clinical investigation (ISO 14155 )
- Most likely to be needed for higher risk class devices or for devices where there is little or no
clinical experience

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4.5. Use of Existing Bibliography
• Contain copies of all the literature studies, or existing bibliography
• Relevant publications in peer-reviewed scientific literature

4.6. Validation on Sterilization Method

• Ethylene oxide
• Gamma Ray
• Autoclave steam
• Chlorine dioxide
• Electron beam

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5. Medical Device Labelling
.
Medical Device Labeling
(Sixth Schedule of Medical Device Regulations 2012)

Do provide:
5.1. Declaration on Labeling
5.2. Sample of Device Labeling
5.3. Document on IFU, User Manual, Technical Manual, Brochure, etc

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6. Risk Management
.
 Risk Management
➢ Risk management is a key component in demonstrating regulatory
compliance for medical devices.
➢ Recommended to follow ISO 14971.
➢ This standard will help manufacturers to establish a medical
device risk management process that can be used to identify hazard, to
estimate and evaluate risks, and to implement and monitor the
effectiveness of risk control measures during the product life cycle.

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Overview Of Risk Management Process
Establish framework and
specify intended used.
Identify hazards

Define hazardous situation

and foreseeable sequences
of events
Estimate Risk and evaluate the risk
identified
Risk Controls

Evaluate Overall Residual Risk

Acceptability
Risk Management Report

Production & Post production Information

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6.1 Risk Analysis
• to identify hazards and to estimate the risk

6.2 Risk Evaluation

• Risk evaluation matrix to define acceptable or unacceptable risk
• Is risk reduction are required?

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6.3 Risk Controls
• to reduce and mitigate unacceptable risks
• Priorities; 1) Product Design
2) Protective measures incorporated with in the medical device
3) Labeling, instructions for use
6.4 Residual Risk Acceptability
• to evaluate and document whether or not the product meets the
acceptability criteria defined by the company.
6.5 Production & Post production Information
• involve systematic review of risk management file and be
updated when events such as complaints, product feedback, non-
conformances, etc. occur.
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7. Manufacturer Information
.
7.1. Manufacture information
• Provide address of all manufacturers involved in the device
manufacturing process

7.2. Manufacturing Process

• Provide flow chart on the manufacturing process

7.3. Quality Management System Certificate

• Provide the ISO 13485 certificate from the manufacturer

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Thank You