Malaysia medical device QA/RA blog

News and commentary on regulatory changes.

Malaysia Extends Deadline for Medical Device Registrations

The Medical Device Authority (MDA), Malaysia’s medical device market regulatory agency, has extended its deadline for temporary expedited device registrations to June 30, 2016.

Malaysian MDA extends deadline for temporary medical device market accessThe fast-track program, originally set to expire July 1, 2015, now allows manufacturers to freely sell their devices in Malaysia provided that they submit registration applications to the MDA no later than June 30, 2016. Emergo consultants have verified with MDA officials that the expedited pathway is available to all devices, not just those that were already marketed in Malaysia prior to the old July 2015 deadline.

The MDA’s extension means significantly fewer barriers to entry into the Malaysian market for foreign medical device manufacturers—at least until summer 2016. Emergo will continue monitoring the situation and stay in contact with the MDA for any additional details concerning this news.

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