Malaysia Medical Device Authority Leads Harmonized Post-Market Surveillance for Medical Device Safety

The Malaysia Medical Device Authority (MDA) has introduced a landmark guidance document aimed at streamlining post-market surveillance and data exchange across the Association of Southeast Asian Nations (ASEAN). This initiative, outlined in the guidance MDA/GD/0067, is in response to the collective decision made during the 12th ASEAN Medical Device Committee meeting in Brunei in September 2023. The document draws inspiration from the International Medical Device Regulators Forum (IMDRF), focusing on enhancing the collaboration among the ASEAN countries – Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam – to address serious public health concerns related to medical devices.

This guidance outlines specific scenarios that necessitate the exchange of critical information among ASEAN countries, such as the detection of adverse event trends and the identification of medical devices that could potentially lead to public health threats. By adopting a uniform approach to information exchange, as detailed in MDA/GD/0067, ASEAN wants to ensure the safety and efficacy of medical devices within this large market. Moreover, the guidance signifies a shift in regulatory focus towards a more integrated and cooperative approach to medical device surveillance, following international standards. Unlike previous MDA documents that were more nationally focused, MDA/GD/0067 aligns closely with the ASEAN Medical Device Directive (AMDD), highlighting a unified strategy for post-market surveillance across the region.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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