New Malaysian medical device market regulations published

February 1, 2013 by MassDevice staff

Global Medicine

By Stewart Eisenhart, Emergo Group

New regulations requiring mandatory registration of medical devices in Malaysia have been officially adopted by the government, and go into effect on July 1, 2013. Following implementation of the new regulatory system, medical device manufacturers will have a two-year transition period to register with the Medical Device Authority (formerly the Medical Device Control Division, or MDCD) of the Malaysian health ministry, as well as a one-year grace period to comply with establishment licensing requirements.

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The Malaysian system bears many similarities to the regulatory framework now in place for medical devices in Singapore. Key components of mandatory medical device registration and approval in Malaysia include: