Asean states differ in readiness for single medical device submission, says Dzulkefly

Health Minister Dzulkefly Ahmad stated that Asean member states are at varying stages of readiness to adopt a single-submission model for the pre-market approval of medical devices. Some nations are still developing their regulations and legal frameworks, while others, such as Singapore and the Philippines, are more advanced. In his press conference at the 17th Asean Health Ministers Meeting, Dzulkefly emphasized the importance of not leaving the weakest member states behind and highlighted the need for all countries to move forward together.

The Asean Strategic Health Agenda 2026-2030 aims to implement this model as soon as possible, but acknowledges that achieving interoperability across all 11 member states would be a long shot. During the first Asean roundtable discussion on medical devices, Malaysia was proposed as the coordinating entry point for initial implementation, responsible for receiving and coordinating the distribution of technical dossiers.