Malaysia Proposed As Coordinating Entry Point For ASEAN Single Submission Model For Medical Devices
KUALA LUMPUR, Sept 9 (Bernama) -- Malaysia has been proposed as the coordinating entry point for the initial implementation of the single submission model for the pre-market approval of medical devices in ASEAN.
Health Minister Datuk Seri Dr Dzulkefly Ahmad said the proposal received the full support of ASEAN member states during the First ASEAN Roundtable on Medical Devices organised by the Medical Device Authority (MDA) and chaired by him today.
He said the landmark roundtable was attended by ASEAN health ministers and delegates from Brunei, Cambodia, Laos, Myanmar, Thailand, Vietnam, Timor-Leste, Indonesia and the Philippines.
“Following the discussions, all member states agreed in principle to support the phased development of a single submission model for the pre-market approval of medical devices.
“More significantly, the meeting fully supported Malaysia serving as the coordinating entry point for the initial implementation of the framework, particularly for receiving and coordinating the distribution of technical dossiers,” he said in a Facebook post.
Under this model, he said regulatory authorities can minimise duplication of work, while each country retains final authority over the registration of medical devices in accordance with its respective laws.
Dzulkefly said that following the agreement, the ASEAN Medical Device Committee (AMDC), together with the ASEAN Secretariat, would be tasked with developing the implementation mechanism ahead of the AMDC meeting in Vientiane, Laos, from Oct 6 to 8.
“This strategic initiative will strengthen patient safety while ensuring that the region has rapid and equitable access to quality medical devices,” he added.
-- BERNAMA
