MDA guidance on re-registration of medical devices

Malaysia’s Medical Device Authority (MDA) has finalized its re-registration guidance. The document covers the submission of re-registration applications for all classes of medical devices that have expired or near-expiry registrations.

MDA has established a two-step process for the re-registration of medical devices. First, the holder of the registration must apply for review by a conformity assessment body. The conformity assessment must cover the quality management system, postmarket surveillance system, technical documentation, and declaration of conformity. The body will also review any change notification documents approved by MDA. Companies can move on to the second step after undergoing a satisfactory assessment.

The second step covers the application for re-registration itself. Once a registration enters its final year, a re-registration button will appear in MDA’s system. Registration holders can then apply to re-register their devices through the MeDC@St application system. If a company has done change notifications, the button will show up on the completed change notification application. The button will not appear if the change notification application is incomplete.

Exactly what information the applicant needs to provide depends on the nature of the medical device that is being re-registered. MDA is asking applicants with Class A sterile medical devices to upload their validation reports, while companies with combination products should provide an endorsement letter issued by Malaysia’s National Pharmaceutical Regulatory Agency.

MDA has provided a flowchart to walk applicants through the two-step process. The flowchart covers the timing of the payment of the application and registration fees, both of which are paid via the MeDC@St portal. RAPS.org