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Objectives and Scope of the ACCSQ-MDPWG |
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The MDPWG will assist the ACCSQ in implementing specific measures to facilitate the integration of the medical devices sector through elimination of technical barriers to trade in ASEAN. These measures, among others, include the following: | 1 | Developing a common submission dossier template for product approval in ASEAN
| | 2 | Exploring the feasibility of an abridged approval process for medical devices which regulators of benchmarked countries or recognized regulators have approved
| | 3 | Exploring the feasibility of adopting a harmonized system of placement of medical devices into the ASEAN markets, based on a common product approval process
| | 4 | Formalizing of a post-marketing alert system for defective or unsafe medical devices.
| | 5 | All ASEAN countries to consider joining the Asian Harmonization Working Party (AHWP) and work in parallel with the Global Harmonization Task Force (GHTF) on technical harmonization efforts |
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