Sep 4, 2014

A recent meeting of Southeast Asian economic ministers in Myanmar has yielded a formal signing of an agreement between 10 nations to establish a harmonized medical device registration framework.

The Association of Southeast Asian Nations (ASEAN) Medical Device Directive, or AMDD, was signed by representatives of the 10 ASEAN member states: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam. As previously reported by Emergo, the AMDD will establish a consistent path to market for foreign medical device manufacturers registering their products in ASEAN member states.

In terms of actual AMDD implementation dates, however, no official time frame has yet been set. Current medical device regulatory systems in Singapore and Malaysia, however, provide a good indication of what an ultimate ASEAN framework will look like.


  • Stewart Eisenhart