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.
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:
Emergo Group has also learned that expedited review pathways will be available for some medical devices, but the Medical Device Authority will perform these reviews administratively; therefore, the regulations do not specify the expedited review option.
Medical device registration applications will have to be submitted to the Medical Device Authority using an online system that will launch by July 2013.
We will provide additional details as we learn them.