Medical Device Re-registration Starting in Malaysia

On July 1, 2016, Malaysia’s Medical Device Authority (MDA) made it mandatory for all foreign manufacturers to register their medical device products with the MDA. These medical device registrations would be valid for 5 years, which means re-registration is now starting. Although the MDA has not officially determined the requirements for re-registration, certain documents such as basic medical device information, conformity assessment of quality management system, letter of authorization, etc. will be required. Class A medical device re-registrations will be reviewed by the MDA, while class B, C, and D medical device re-registrations will require review from both the Conformity Assessment Body and the MDA. The government re-registration fees will be the same as the new registration fees, which can be found here on the MDA website. The estimated timeframe for re-registration application evaluation by the MDA is 3 to 6 months.