Malaysia Updates Guidance on Medical Device Registration– Verification Process for Class A–D Devices

"The Medical Device Authority (MDA), Ministry of Health Malaysia, has issued the second edition of guidance document MDA/GD/0070 (September 2025) on the registration of medical devices through the MeDC@St system using conformity assessment by way of verification. The guidance applies to Class A devices as well as Class B, C, and D devices undergoing verification via Conformity Assessment Bodies (CABs).

Among the main revisions are the removal of the one-year marketing requirement for verification, the inclusion of Singapore (HSA) and Thailand (Thai FDA) as recognized regulatory authorities, updated post-market surveillance timelines (reduced from past 3–5 years to past 3 years), and additional evidence requirements for pre-market approval from Singapore and Thailand. The document is designed to streamline registration and re-registration for devices already approved in recognized countries, while ensuring compliance with the Medical Device Act 2012 (Act 737) and maintaining safety and performance standards."