The ASEAN Medical Device Directive (AMDD) is a harmonized medical device regulation applicable across the ASEAN countries. The Association of Southeast Asian Nations (ASEAN) has signed the ASEAN agreement on medical device directive accepting the AMDD.

In Which Countries is the AMDD Valid?

The ASEAN Medical Device Directive (AMDD) is adapted by the group of ten (10) countries of Southeast Asia including Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. These countries are at different stages of adapting and implementing the Directives. In brief:

  • Singapore, Malaysia, and Indonesia are in advance stages and have fully complied with the AMDD
  • The Philippines, Thailand, and Cambodia have revised their national regulations to comply with certain requirements of the directives. More changes are yet to be made to fully comply with the AMDD
  • Laos and Myanmar are in the process of establishing new regulations

How are Medical Devices Classified under the AMDD?

The medical devices are classified into four (4) classes by the AMDD based on their risk levels. The risk levels increase from Class A to Class D.

Class

Risk Level

A

Low Risk

B

Low – Moderate Risk

C

Moderate – High Risk

D

High Risk

 

What is the Structure of the AMDD?

The ASEAN Medical Device Directive (AMDD) has 24 Articles and 8 Annexes. Out of the 24 articles, last 6 articles are related to the legalities of the Directive and are not related to the device.

Articles under the AMDD

Annexes of an AMDD
  1. General provisions 
  2. Definition and scope of medical devices
  3. Essential requirements of safety and performance of medical devices
  4. Classification of medical devices
  5. Conformity assessment of medical devices
  6. Registration and placement of devices on market
  7. Registration of persons responsible for placing medical devices on the markets of the Member States
  8. Technical documents for medical devices (Common Submission Dossier Template (CSDT), Declaration of Conformity, etc.) 
  9. Relevant technical standards (ISO, etc.)
  10. Labeling
  11. Medical device claims
  12. Post-marketing alert system
  13. Clinical investigation
  14. Institutional arrangements
  15. Safeguard clauses
  16. Confidentiality
  17. Special cases
  18. Implementation 
  19. Revisions, modifications and
  20. Dispute settlement
  21. Reservations
  22. Entry into force
  23. Annexes
  24. Depository
  1. Essential Principles of Safety and Performance of Medical devices
  2. Risk classification rules for medical devices other than IVD medical devices
  3. Risk classification rules for IVD medical devices
  4. ASEAN CSDT template
  5. Post Marketing Alert System (PMAS) requirements
  6. Components Elements of a product owner’s or physical manufacturer’s Declaration of Conformity
  7. Labeling requirements
  8. Clinical investigation

 

 

What are the Requirements Under AMDD?

  • A Common Submission Dossier Template (CSDT) for product approval including samples of labeling, packaging materials and full instructions
  • Declaration of Conformity (DoC) stating compliance with the EPSP and listing device name, applicable standards, location of test results, manufacturer information and responsible person
  • Local clinical trials are required for some Class III or IV devices. The studies are not required for Class I and II devices
  • Conformity assessment review of quality management and post-market surveillance systems
  • Post-marketing alert system for identification of unsafe and defective devices and adverse events reports

Unsolved issues of the AMDD include language requirements, whether English or local, and the use of third-party, independent bodies for conformity assessments.

Which Information is Required to Demonstrate Conformity to the ERSP?

Manufacturers of all classes of medical device are expected to demonstrate the conformity of the device to the EPSP through collection and examination of evidence of conformity in technical documentation, that shows how each medical device was developed, designed and manufactured together with the descriptions and explanations necessary to understand the manufacturer’s determination with respect to such conformity. The information required to demonstrate the compliance with Essential Requirements of Safety and Performance (ERSP) consist of six (06) general principles that apply to all the medical devices and 11 principles of design and manufacturing, some of which are relevant to each medical device.

Would you like to gain comprehensive insights on the ASEAN medical device regulations? Reach out to a Regulatory expert for end-to-end information and Regulatory consultation in the ASEAN market or in any of the ASEAN Member State (AMS).