Kuala lumpur: 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.
According to BERNAMA News Agency, Dr Dzulkefly highlighted that during the side event of the 17th ASEAN Health Ministers Meeting (AHMM) and Related Meetings, valuable input and best practices were received, particularly noting the Philippines' suggestion for a connected and interoperable system. He emphasized that establishing such a system across all 11 ASEAN member states would require time due to varying stages of regulatory and legal framework development among the countries. Some countries, like Singapore and the Philippines, have advanced systems, while others are still in developmental phases.
Member states have agreed in principle to support a phased Single Submission Model for the pre-market approval of medical devices, with Malaysia set to act as the coordinating entry point for technical dossiers. This agreement was reached during the inaugural ASEAN Roundtable Discussion on Medical Devices, chaired by Dr Dzulkefly, as part of the specialised technical sessions held in conjunction with the 17th AHMM.
On the topic of bilateral engagements, Dr Dzulkefly mentioned that Malaysia has reinforced its Memorandum of Understanding on Health Cooperation with Singapore, which expands collaboration in areas such as digital health, active ageing, and regulatory reliance between the Medical Device Authority and Singapore's Health Sciences Authority. Additionally, Malaysia and Indonesia have made progress in digital health, Traditional and Complementary Medicine, and cross-border healthcare initiatives, with Malaysia's medical tourism sector generating more than RM2.2 billion in revenue in 2025.
Dr Dzulkefly also expressed anticipation for strategic bilateral sessions with China and Japan to further expand technical and investment ties. The 17th AHMM marks a significant diplomatic milestone, featuring 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).