About the AMDC
The ASEAN Medical Device Committee (AMDC) was formed in 2014 to coordinate the implementation of the ASEAN Medical Device Directive (AMDD), an agreement between the 10 ASEAN members states to harmonise medical device regulatory framework. The key objective is to facilitate trade and market access of medical devices in ASEAN by reducing technical barriers.
The AMDC is progressing towards regulatory convergence for medical devices by
- Establishing common understanding of AMDD through the development of an interpretative matrix
- Harmonising requirements for adverse events reporting through the implementation of guidelines on post market surveillance
- Aligning the risk classification of medical devices across ASEAN member states
For more information on the work progress of the AMDC, please refer to the ASEAN website (Key Documents and Publications > HARMONISATION OF STANDARDS & TECHNICAL REQUIREMENTS > ASEAN Medical Device Committee (AMDC).