The Association of South East Asian Nations (ASEAN) is a regional bloc composed of ten countries: Brunei Darussalam, Burma, Cambodia, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand, and Vietnam. It was established in 1967 with five founding countries, and the other countries joined the group at different times.
One of the objectives of the ASEAN is to facilitate trade and promote regional integration.
The ASEAN governing bodies decided to have a harmonized approach to medical device regulations in the ASEAN Free Trade Zone. With this as an objective, an Agreement called the ASEAN Medical Device Directive (AMDD) was established. This Agreement entered into force on 1 January 2015. Though this Directive is not binding on the member states, all member states are expected to establish common harmonized rules in line with it. The ASEAN Medical Device Committee (AMDC) established in 2014 oversees the implementation of the AMDD.
Key features of the AMDD:
Classification
There are four risk-based classifications A, B, C and D.
A: Low Risk
B: Low-Moderate Risk
C: Moderate-High Risk
D: High Risk
Medical devices are classified as per 16 rules given in Annex 2 of the Directive.
IVD devices are classified as per 7 rules given in Annex 3 of the Directive.
Essential Principles
A common set of Essential Principles is defined for all medical devices. Annex 1 of the Directive states 19 broad requirements, which are classified into General Requirements and Design and Manufacturing Requirements.
Common Technical Documents
The AMDD states the requirements for three sets of common technical documents.
Annex 4: ASEAN Common Submission Dossier Template (CSDT)
Annex 5: Post Marketing Alerts System Requirements (PMAS)
Annex 6: Harmonised set of elements for a Product Owner’s or Physical
Manufacturer’s Declaration of Conformity (DOC)
Common Harmonized Standards
To comply with the applicable essential requirements, a manufacturer can conform to either the common technical standards recognized by the AMDC or other standards recognized by the regulatory authority of a member state. A list of harmonized standards is available from the website www.atr.asean.org/standards.
Labelling
Annex 7 of the AMDD has set the common rules for labelling of medical devices. The AMDD recognizes a set of internally accepted harmonized symbols on the labelling.
