Malaysia to coordinate ASEAN medical device submission model

ASEAN member states have agreed in principle to implement a phased Single Submission Model for the pre-market approval of medical devices. Under this initiative, Malaysia will serve as the coordination hub for the submission of technical documentation to streamline the process and reduce redundant work among regional regulatory authorities.

The agreement was reached during the first ASEAN Roundtable Discussion on Medical Devices, held as part of the 17th ASEAN Health Ministers Meeting (AHMM17) in Kuala Lumpur. While the model aims to facilitate easier access to quality medical devices, Malaysian Health Minister Datuk Seri Dr Dzulkefly Ahmad emphasized that each nation retains final decision-making authority regarding device registration based on its own domestic laws.

The ASEAN Medical Device Committee (AMDC), in collaboration with the ASEAN Secretariat, is tasked with drafting the implementation mechanism, with plans to review it during a meeting in Vientiane, Laos, this October. The initiative follows discussions on interoperability, with the Philippines suggesting a system that allows for mutual handling across member states. Implementation will be gradual, accounting for the varying levels of regulatory development across the 11 member nations.