Asean eyes single submission model for medical device approval
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.
KUALA LUMPUR: The proposed Asean Single Submission Model for medical device pre-market approval could become a reality once member states approve the initiative, Health Minister Datuk Seri Dr Dzulkefly Ahmad said. The agenda item is currently under consideration, with Asean countries sharing input and best practices during the 17th Asean Health Ministers Meeting (AHMM) and Related Meetings.
The Philippines suggested an interoperable system, noting that establishing one across all 11 member states would take time as countries are at varying stages of development. Malaysia, serving as the coordinating entry point, will handle technical dossiers for the phased Single Submission Model. Bilateral agreements include Malaysia strengthening its Memorandum of Understanding with Singapore in digital health and regulatory reliance, and Malaysia and Indonesia advancing initiatives in digital health, Traditional and Complementary Medicine, and cross-border healthcare.
Dzulkefly expressed anticipation for strategic bilateral sessions with China and Japan to further strengthen technical and investment ties. The 17th AHMM also serves as a significant diplomatic milestone, featuring the inaugural Asean-United States and Asean-Japan Health Ministers Meetings, along with high-level consultations with China, the Republic of Korea, and the World Health Organisation (WHO).
Written by urgent.news from New Straits Times's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
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