General : ASEAN Eyes Single Submission Model For Medical Device Approval

Health Minister Dzulkefly Ahmad disclosed that Asean member states are currently at varying stages of readiness to adopt a singular submission model for pre-market approval of medical devices. Some countries are still formulating their regulations and legal frameworks, whereas others, such as Singapore and the Philippines, are more advanced in their implementation.

The minister emphasized the importance of not leaving the weakest member states behind. When asked about the operational timeline of the single-submission model, Dzulkefly stated that the Asean desired to implement it as soon as possible while ensuring all member states could proceed together. He acknowledged that achieving a fully interconnected system across all 11 member states would be a significant challenge.

The Asean Strategic Health Agenda (ASHA) 2026-2030, launched during the 17th Asean Health Ministers Meeting (AHMM), outlines a five-year plan for regional health cooperation in various areas. During the AHMM, Malaysia chaired the first Asean roundtable discussion on medical devices, where Asean member states agreed to support the phased development of a single-submission model.

Malaysia was chosen as the coordinating entry point initially, responsible for receiving and coordinating the distribution of technical dossiers. The Asean Medical Device Committee and Secretariat are set to develop the implementation mechanism ahead of their meeting in Vientiane, Laos, from October 6 to 8.