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.
The AHWP framework targets greater coordination with the APEC Regulatory Convergence for Medical Products, which pushes greater regulatory convergence among APEC members by 2020, and the ASEAN Medical Device Directive (AMDD), which would establish a single medical device regulatory community among ASEAN member states by 2015.
The Health Sciences Authority (HSA) of Singapore and the Malaysian Ministry of Health have signed on to a memorandum of understanding in which both agencies will collaborate on regulatory science, enforcement efforts, post market vigilance and quality system issues impacting their respective markets.