Philippines: PFDA Released Draft Regulation on Extension of Regulatory Flexibility for Non-Registrable Class B, C and D Medical Devices

During the harmonization to ASEAN requirements, PFDA aims to prevent a negative impact on the supply of medical devices by issuing past provisions FC No. 2021-002A, FC No. 2021-002B, and FC No. 2021-002C (valid until Mar 31, 2024) which provide regulatory flexibility to all Class B, C, and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-001A.

As the provided extensions stated in FC No. 2021-002-C are coming to an end, the FDA will be providing an extension of the regulatory flexibility to assist the medical device industry in complying with the regulatory requirements based on the ASEAN Common Submission Dossier Template (CSDT).

In February 2024, PFDA released a draft regulation for public comments regarding the extension of Regulatory Flexibility for Non-Registrable Class B, C and D Medical Devices. The following are the draft guidelines for the said extension:

1. Class B, C, and D medical devices that are not included in the list of registrable medical devices based on FC No. 2021-001-A are allowed to be manufactured, imported, exported, distributed, transferred, sold, or offered for sale without CMDN until September 30. 2024.
2. Application for CMDN of affected medical devices shall be accepted until September 30, 2024. Receiving of CMDN will stop starting October 1, 2024.
3. Establishments may opt to apply for CMDR instead of CMDN for their products before October 1, 2024.
4. After October 1, 2024, CMDR is needed to be applied for the affected medical devices. Furthermore, affected devices that have no CMDN/CMDR or without pending application for CMDN/CMDR shall not be allowed to be manufactured, imported, exported, distributed, transferred, sold, or offered for sale.

Stakeholders are encouraged to send in their comments to cdrrhr-prsdd@fda.gov.ph on or before February 22, 2024.

For more information, refer to the following link: Draft for Comments || Extension of 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”” – Food and Drug Administration

Reference attachments:

FDA Circular No. 2020-001-A – Amendment to Annex A if FDA Circular No. 2020-001 re: Initial Implementation of AO 2018-0002

FDA Circular No. 2021-002-C – Guidelines of the Regulatory Flexibility of Class B, C and D Medical Devices

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