Philippines: Food and Drug Administration (FDA) issues Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices not included in the Registrable List of Medical Devices
In consideration of the challenges brought about by the full implementation of AO 2018-002, the FDA recognizes that there is a need to provide medical device companies more time to prepare the technical documentary requirements based on the ASEAN Common submission dossier template (CSDT) in applying for CMDR. With this, the Philippines FDA issued the FDA Circular No 2021-002-C: Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A entitled “Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order NO. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”.
This circular provides extension on the implementation of the mandatory registration of Class B, C and D medical devices that are NOT INCLUDED in the List of registrable medical devices based on FC No. 2020-001-A.
|Activities||Dates to Remember|
|May continue to be manufactured, imported, exported, distributed, transferred, sold or offered for sale without CMDN||Until: 31 March 2024|
|Accepting Application for CMDN for Class B, C and D medical devices covered under this Circular||Until: 31 March 2024|
|Application of CMDN for Class B, C and D medical devices covered under this Circular shall cease but companies may opt to apply for CMDR instead of CMDN for their products prior to this date.||Starting: 01 April 2024|
|Prohibits the manufacture, Importation, exportation, distribution, transfer, selling or offering for sale of all Class B, C and D medical devices covered under this Circular without CMDN/CDMR or with pending application for CMDN/CMDR||Starting: 01 April 2024|
Marketing Authorization Holder (MAH) with expiring CMDN for Class B, C and D medical devices shall apply for CMDR at least six (6) months prior to its expiration. If CMDR is on process, the MAH may continue to manufacture, import, export, distribute and/or sell the product. The issued CMDN and proof of application for CMDR shall be provided at the point of entry and/or part of bidding requirements.
Effectivity: Immediately after its publication in the Official Gazette or in a newspaper of general circulation and filing three (3) certified true copies with the University of the Philippines – Office of the National Administrative Register.
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