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Philippines (FDA) - FC No. 2021-002-B - Authorization of Medical Devices
On April 21, 2022, the FDA issued FDA Circular (FC) No. 2021-002-B detailing the amendments to FC No. 2021-002-A entitled “Addendum to FDA Circular No. 2021-002 Re: 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.”
The amendments extend the date to March 31, 2023 wherein all the non-registrable Class B, C and D medical devices stated in Section III of the Circular may continue to be manufactured, imported, exported, distributed, transferred, sold or offered for sale without a Certificate of Medical Device Notification (CMDN). Furthermore, the start period is extended to April 1, 2023 for requiring a CMDN or at least a pending CMDN application for the aforementioned medical devices.
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