By Stewart Eisenhart, Emergo Group
The Medical Device Authority (MDA), Malaysia’s nascent medical device regulatory agency, has published a draft of its proposed new market regulation and is seeking public comment ahead of implementation.
As drafted, the Medical Device Regulation 2012 borrows from World Health Organization and Global Harmonization Task Force principles. The Malaysian regulation covers conformity assessment requirements, abridged and full registration pathways, as well as post-market vigilance requirements—very similar to the medical device regulatory system in Singapore.
Interested parties have until September 25 to submit comments on the draft regulation to the Malaysian Ministry of Health.
The new Malaysian regulatory system for medical devices is scheduled to take effect in late 2012 or early 2013, and will replace the voluntary registration process now in place.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.