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Navigating the Medical Device Registration Process in Malaysia: What You Need to Know

Since the implementation of Act 737 (Medical Device Act 2012), it has become a regulatory requirement to register all medical devices with the Malaysian Medical Device Authority (MDA). This registration process can be completed electronically through the web-based Medical Device Centralized Application System (MeDCASt).

 

For foreign manufacturers looking to market their medical device products in Malaysia, it is essential to have a local authorized representative, which is a locally registered business entity, to handle the registration of their medical devices with MDA. Importation of unregistered medical devices is only permitted with special authorization or medical device exemption approval from MDA, regardless of the import purposes (e.g., clinical research, non-clinical use, exhibition, and demonstration).

 

At InnoSignum, we specialize in supporting the registration of medical devices in Malaysia. Through our affiliated companies, fully capable of serving as your Malaysian Authorized Representative, Importer, and/or Distributor, we provide comprehensive assistance from product registration to commercialization in Malaysia.

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