Asia to get its own Medical Device Directive
Written by Andres Heuberger on Monday, January 12, 2009
The 10-member Association of Southeast Asian Nations (ASEAN) is developing it's own medical device directive (AMDD).
Under the 18-article AMDD, device manufacturers will be required to register with each national regulatory authorities and to submit technical documents through a Common Submission Dossier Template. The AMDD is expected to include language requirements similar to Europe's MDD.
According to the report from ASEAN's working party, member countries will sign the finalized AMDD in July 2009 with national transpositions occurring in 2010.
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