Malaysia to lead ASEAN single-submission model for medical devices
MALAYSIA will coordinate technical document submissions under a proposed ASEAN-wide system aimed at reducing duplication in the approval of medical devices across the region. Health Minister Datuk Seri Dr Dzulkefly Ahmad said ASEAN member states had ...
Malaysia will lead the ASEAN effort to implement a phased single-submission system for pre-market medical-device approvals, in a move aimed at reducing duplication among the region's regulatory authorities. Health Minister Datuk Seri Dr Dzulkefly Ahmad said ASEAN members had agreed in principle to the model, with Malaysia appointed as the coordinating hub for technical document submissions.
The ASEAN Medical Device Committee and Secretariat will develop the implementation mechanism ahead of a meeting in Vientiane, Laos, in October, but the rollout will depend on each country's regulatory readiness. Malaysia's experience with AI-assisted chest X-ray screening and its rare diseases playbook are highlighted as examples of the country's commitment to strengthening regional cooperation on health issues.
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