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KUALA LUMPUR - Asean member states are at different stages of readiness to implement a single-submission model for the pre-market approval of medical devices, with some countries still developing their regulatory and legal frameworks.
Health Minister Datuk Seri Dr Dzulkefly Ahmad said countries such as Singapore and the Philippines were more advanced in this area.
However, he said Asean must ensure that less-prepared member states were not left behind as the region worked towards establishing a common system.
“We must accept the fact that the 11 states are at different levels of implementation. Some are still working on their regulations and legal frameworks.
“What is important, as I have always said, is to never to leave the weakest behind,” he said in a press conference at the 17th Asean Health Ministers’ Meeting (AHMM) and Related Meetings following the launch of the Asean Strategic Health Agenda (ASHA) 2026-2030 here today.
Dzulkefly was responding to a question on when the proposed single-submission model for medical device pre-market approval could become operational across Asean.
He said Asean wanted to implement the model as soon as possible, but progress had to take into account the varying levels of regulatory preparedness among its 11 member states.
“The Philippines had proposed connecting the systems and making them interoperable across Asean. But achieving this across all 11 member states is a very long shot.
“The differing levels of readiness mean that Asean would need to continue working towards greater regulatory alignment before a fully integrated single-submission model could be implemented region-wide,” he added.
Dzulkefly stressed that greater regional integration must be balanced with the need to ensure countries with less-developed regulatory frameworks can progress alongside more advanced Asean member states.
The issue is part of broader efforts to strengthen health cooperation and regulatory coordination within Asean, particularly to improve access to healthcare technologies and medical devices.
Launched during the 17th AHMM, ASHA 2026-2030 serves as a five-year roadmap for regional health cooperation, covering healthy lifestyles and non-communicable disease prevention, emerging public health threats, health systems and access to care, and food safety.
The agenda aims to guide ASEAN’s health cooperation while supporting the development of more equitable and future-ready health systems across the region.
The 17th AHMM, chaired by Malaysia in Kuala Lumpur, began on Sept 7 and concludes tomorrow.