New Malaysian Medical Device Market Regulations Published
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:
- Risk-based classification of devices: Class A (lowest risk), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (highest risk)
- Use of Conformity Assessment Bodies (CAB): Licensed CABs will be responsible for reviewing and certifying registration applications prior to final approval from the Medical Device Authority (the regulator will publish a list of authorized CABs online by July 2013)
- Authorized representation: foreign manufacturers with no local presence in Malaysia will be required to appoint Malaysia Authorized Representatives to manage their registrations on their behalf and manage post-market vigilance requirements
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.