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 agreed in principle to implement the Single Submission Model for pre-market medical-device approvals in phases.
“We have achieved an important milestone in the medical-device sector, with ASEAN member states agreeing in principle to support the phased implementation of the Single Submission Model for pre-market approval.
“The model is expected to help reduce duplication in the assessment and approval of medical devices among the regulatory authorities of ASEAN member states,” he said at a press conference in conjunction with the 17th ASEAN Health Ministers’ Meeting (AHMM17) Kuala Lumpur on Thursday.
He said the agreement was reached at the first ASEAN Medical Device Roundtable Discussion, with Malaysia designated as the coordinating hub for technical document submissions.
However, Dr Dzulkefly stressed that each country would retain the authority to make final decisions on medical-device registration under its respective laws and regulations.
The ASEAN Medical Device Committee (AMDC) and ASEAN Secretariat will next develop an implementation mechanism for the model ahead of the AMDC meeting in Vientiane, Laos, in October.
Dr Dzulkefly said efforts were under way to introduce the system as soon as possible, but its rollout would depend on the regulatory readiness of all 11 ASEAN countries.
He said member states were at different stages of regulatory development, with some still developing their regulatory frameworks while countries such as Singapore and the Philippines were more advanced.
He said the model therefore had to be implemented inclusively to ensure faster regulatory coordination did not leave less-prepared member states behind.
“If we want to move quickly, we must ensure that the others are also moving with us.
“So, it is very important, as I have said, not to leave anyone behind,” he said.
Dr Dzulkefly also highlighted Malaysia’s experience in AI-assisted chest X-ray screening under the Lung Health Initiative, which covers tuberculosis (TB), chronic obstructive pulmonary disease (COPD) and lung cancer.
“Through nationwide screening assisted by AI, we are actively shifting from a ‘treat when sick’ approach to proactive early detection.
“We welcome other ASEAN member states to explore and adapt this model as we work together to build stronger and more resilient health systems across the region,” he said.
Malaysia also introduced its Malaysia’s Rare Diseases Playbook as a practical resource for sharing best practices and strengthening regional cooperation on rare diseases.
Dr Dzulkefly said Malaysia was also strengthening bilateral health cooperation with Singapore in digital health, active ageing and regulatory reliance between Malaysia’s Medical Device Authority (MDA) and Singapore’s Health Sciences Authority (HSA).
Cooperation with Indonesia covers digital health, Traditional and Complementary Medicine and cross-border healthcare.
AHMM17 was held from Sept 7 to 11 under the theme ‘Healthy ASEAN: Together Towards Equitable and Future-Ready Health Systems’. - September 12, 2026
