ASEAN Medical Device Committee (AMDC)
What is the AMDC?
The ASEAN Medical Device Committee (AMDC) is the body responsible for developing and implementing the harmonised medical device regulatory framework across ASEAN member states. It operates under the ASEAN Economic Community's goods-related committees.
The AMDC's goal is to harmonise medical device regulation across the 10 ASEAN countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam) to facilitate trade and improve access to safe medical devices across the region.
HSA's AMDC page: hsa.gov.sg/medical-devices/international-collaboration-medical-devices/amdc
The ASEAN Medical Device Directive (AMDD)
The ASEAN Medical Device Directive (AMDD) is the foundational policy document for ASEAN medical device harmonisation. It establishes the common regulatory framework principles for ASEAN member states, including:
- A common definition of medical device;
- A common classification system (Class A/B/C/D, aligned with GHTF principles);
- Common requirements for registration, licensing, and post-market surveillance;
- Mutual recognition and reliance arrangements between ASEAN members.
Singapore's HP(MD) Regulations framework is aligned with the AMDD.
What ASEAN harmonisation means for manufacturers
For manufacturers seeking to supply medical devices across ASEAN, AMDD alignment means that:
- A Singapore registration demonstrates compliance with AMDD requirements, which many ASEAN authorities recognise or accept as part of their own registration processes;
- A Singapore Free Sale Certificate is commonly required for ASEAN market entry applications;
- The ASEAN Common Submission Dossier Template (CSDT) provides a standardised format for regional submissions — see ASEAN CSDT.