ASEAN Eyes Single Submission Model For Medical Device Approval

KUALA LUMPUR, Sept 10 (Bernama) -- The proposed ASEAN Single Submission Model for the pre-market approval of medical devices could move towards implementation once member states agree to the initiative.

Health Minister Datuk Seri Dr Dzulkefly Ahmad said the proposal is currently being put forward as an agenda item, with ASEAN countries contributing input and sharing best practices on its implementation.

“During the side event (of the 17th ASEAN Health Ministers Meeting (AHMM) and Related Meetings), we received very good input and best practices. The Philippines, in particular, suggested that we should have a system that is connected and interoperable,” he said at a press conference after launching the ASEAN Strategic Health Agenda (ASHA) 2026-2030 programme here today.

Dr Dzulkefly said establishing an interoperable system across all 11 ASEAN member states would take time as countries are at different stages of development, with some still working on their regulatory and legal frameworks while others, including Singapore and the Philippines, are more advanced.

He said member states had yesterday agreed in principle to support a phased Single Submission Model for the pre-market approval of medical devices, with Malaysia serving as the coordinating entry point for technical dossiers.

He said the agreement was reached during the inaugural ASEAN Roundtable Discussion on Medical Devices, which he chaired as part of specialised technical sessions held in conjunction with the 17th AHMM.

On bilateral engagements, Dr Dzulkefly said Malaysia had reinforced its Memorandum of Understanding on Health Cooperation with Singapore, expanding collaboration in digital health, active ageing and regulatory reliance between the Medical Device Authority and Singapore’s Health Sciences Authority.

He said Malaysia and Indonesia had also advanced initiatives in digital health, Traditional and Complementary Medicine and cross-border healthcare, with Malaysia’s medical tourism sector recording more than RM2.2 billion in revenue in 2025.

He added that he looked forward to strategic bilateral sessions with China and Japan to further expand technical and investment ties.

“The 17th AHMM also marks a major diplomatic milestone with the inaugural ASEAN-United States and ASEAN-Japan Health Ministers’ Meetings, alongside high-level consultations with China, the Republic of Korea and the World Health Organisation (WHO),” he said.

-- BERNAMA