To register a medical device for sale in Malaysia, a manufacturer must retain the services of a conformity assessment body (CAB) licensed by the Medical Device Authority to review and certify the registration application. As part of the conformity assessment process, the CAB will conduct a technical file review and an audit of the manufacturer’s quality management system. Certified applications are then submitted to the Medical Device Authority through an online registration system for final review and approval.
In addition to these requirements, manufacturers and importers must obtain an “establishment license” in order to legally market or sell medical devices in Malaysia. Manufacturers with no local presence in Malaysia are also required to appoint a Malaysia Authorised Representative, responsible for managing the device registration process and serving as the manufacturer’s legal representative in all dealings related to the review and approval of the device.