Malaysia has been proposed as the coordinating entry point for the initial implementation of an ASEAN single submission model for the pre-market approval of medical devices, with the proposal receiving support in principle from ASEAN member states. Under the model, regulatory authorities would minimise duplication of work while each country retains final authority over medical device registration under their respective laws. The ASEAN Medical Device Committee and ASEAN Secretariat will develop the implementation mechanism ahead of the committee’s meeting in Vientiane, Laos, from 6 to 8 October. 

 

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