ASEAN member states have agreed in principle to roll out a Single Submission Model for pre-market medical device approvals in phases. Malaysia will serve as the coordinating hub for technical document submissions. The consensus came out of the first ASEAN Medical Device Roundtable Discussion on September 10. This model is meant to cut duplicated assessment work across the region’s regulatory authorities. Under the framework, manufacturers would file one technical dossier for review across participating markets. Each country would still make its own final approval decision under its national regulations. The ASEAN Medical Device Committee (AMDC) and the ASEAN Secretariat will work out how it will be implemented. The rollout will depend on how ready each of the 11 member states’ regulators are, and their “maturity” varies widely.
Singapore’s Health Sciences Authority (HSA) has launched a Registration Support Initiative to help clinically important non-registered medical devices move from the Special Access Route (SAR) onto a formal, sustainable registration pathway. The move addresses devices that serve small patient populations and have limited commercial viability locally, which can make formal registration difficult, despite meeting genuine clinical needs. To lower this barrier, the HSA will waive evaluation fees for eligible devices. Clinicians who identify a qualifying device in their practice are asked to complete a Clinical Justification and Endorsement Form and coordinate with the device supplier to start the process. The inaugural application window runs through December 31, 2026, after which the initiative will reopen annually from October 1 to December 31.