Malaysia announces 2017 plans to ratify the ASEAN Medical Device Directive
17-Mar-17, Emergo
Malaysia’s medical device market regulatory agency has provided updates on various fronts at a recent seminar.
Image: Pacific Bridge Medical
At the seminar, the Malaysian Medical Devices Agency (MDA) covered issues including ratification of the Association of Southeast Asian Nations (ASEAN) Medical Device Directive (AMDD), change notification issues for MDA registrants, and revisions to the country’s existing medical device regulations.
MDA officials at the seminar stated they expect to ratify the AMDD, a framework intended to harmonize medical device regulations across 10 ASEAN member nations, in mid-2017.