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
The 6th AMDC meeting and related events 2018
HSA assumed Chairmanship for the AMDC in 2018 and had successfully hosted the 6th AMDC meeting and its related events in Singapore on 2 – 6 April 2018.
Over 200 local and regional participants from regulatory agencies and medical technology companies came together to share regulatory updates and developments to support capacity building under the AMDC.
The AMDC Stakeholders Forum was jointly organised by HSA and Singapore Manufacturing Federation's Medical Technology Industry Group (SMF MTIG) to facilitate interaction and dialogue between regulators and the industry.