Kuala lumpur: Malaysia has been proposed as the coordinating entry point for the initial implementation of a single submission model for the pre-market approval of medical devices within the ASEAN region. Health Minister Datuk Seri Dr Dzulkefly Ahmad announced this development during the First ASEAN Roundtable on Medical Devices, organized by the Medical Device Authority (MDA) and chaired by him.

According to BERNAMA News Agency, the proposal received unanimous support from ASEAN member states at the landmark roundtable. The meeting was attended by health ministers and delegates from Brunei, Cambodia, Laos, Myanmar, Thailand, Vietnam, Timor-Leste, Indonesia, and the Philippines. Dr Dzulkefly Ahmad highlighted that all member states agreed in principle to support the phased development of a single submission model for the pre-market approval of medical devices.

The meeting also endorsed Malaysia as the coordinating entry point for the initial implementation of the framework, specifically for receiving and coordinating the distribution of technical dossiers. This model aims to minimize duplication of work by regulatory authorities, while allowing each country to retain final authority over the registration of medical devices in accordance with its respective laws.

Dr Dzulkefly further stated that the ASEAN Medical Device Committee (AMDC), in collaboration with the ASEAN Secretariat, will be responsible for developing the implementation mechanism ahead of the upcoming AMDC meeting scheduled in Vientiane, Laos, from October 6 to 8. He emphasized that this strategic initiative will enhance patient safety and ensure rapid and equitable access to quality medical devices across the region.