ASEAN Proposes Single Submission Model for Medical Device Approvals: Dzulkefly
Malaysia to coordinate phased implementation of regional pre-market approval system
KUALA LUMPUR: ASEAN has proposed the establishment of a Single Submission Model for the pre-market approval of medical devices, with Malaysia set to serve as the coordinating hub for the submission of technical documents.
Health Minister Datuk Seri Dr Dzulkefly Ahmad said the proposed model could be implemented once all ASEAN member states reach agreement on the initiative.
He said the proposal is currently being discussed among ASEAN countries, with member states sharing their views and best practices on how the system could be implemented effectively.
“At the side event of the 17th ASEAN Health Ministers’ Meeting (AHMM) and Related Meetings, we received very positive feedback and shared best practices from member states. The Philippines, in particular, proposed that we have an interconnected and interoperable system,” he said.
Dzulkefly said establishing an interoperable system across all 11 ASEAN member states would take time as countries are at different stages of regulatory and legal development.
He noted that while some ASEAN countries are still developing their regulatory and legislative frameworks, others, including Singapore and the Philippines, have already made significant progress in the area.
According to Dzulkefly, ASEAN member states on Wednesday agreed in principle to support the phased implementation of the Single Submission Model for medical device pre-market approval.
Under the proposal, Malaysia would act as the coordination centre for the submission of technical documentation.
The agreement was reached during the inaugural ASEAN Roundtable Discussion on Medical Devices, which Dzulkefly chaired as part of a dedicated technical session held in conjunction with the 17th AHMM.
On bilateral cooperation, Dzulkefly said Malaysia is strengthening its Memorandum of Understanding (MoU) on Health Cooperation with Singapore, including expanded collaboration in digital health, active ageing and regulatory reliance between Malaysia’s Medical Device Authority (MDA) and Singapore’s Health Sciences Authority (HSA).
Malaysia and Indonesia are also intensifying cooperation in digital health, traditional and complementary medicine, as well as cross-border healthcare services.
Dzulkefly said Malaysia’s medical tourism sector recorded more than RM2.2 billion in revenue in 2025, highlighting the country’s growing role as a regional healthcare destination.
He also expressed hope that Malaysia’s strategic bilateral engagements with China and Japan would further expand technical cooperation and investment opportunities in the healthcare sector.
Dzulkefly said the 17th AHMM also marked a significant milestone in ASEAN health diplomacy with the inaugural ASEAN–United States and ASEAN–Japan Health Ministers’ Meetings, alongside high-level engagements with China, South Korea and the World Health Organization (WHO).
The developments are expected to further strengthen regional cooperation in healthcare regulation, digital health, medical technology and cross-border healthcare.