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FDA Circular No.2021-002-B Amendment to FDA Circular No. 2021-002-A entitled "Addendum to FDA Circular No. 2021-002Re:
Full Implementation of Administrative Order No. 2018-0002 entitled "Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements"" aims to extend the date wherein all the non-registrable Class B, C and D medical devices stated in Section III of this Circular may continue to be manufactured, imported, exported, distributed, transferred, sold or offered for sale without CMDN. Furthermore, this Circular also aims to amend the start period for requiring CMDN or at least with pending CMDN application for the aforementioned medical devices.
Relevant documents:
(*) WTO Notification G/TBT/N/PHL/186/Add.3
(*) draft regulation
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