Philippines: 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

During the harmonization to ASEAN requirements, the Philippines Food and Drug Administration (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 ended, PFDA released FDA Circular No.2024-003 containing 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).

PFDA released FDA Circular No. 2024-003, regarding the Extension of Regulatory Flexibility for Non-Registrable Class B, C, and D Medical Devices. The following are the 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 with valid CMDN for Class B, C, and D devices can apply for CMDR anytime within its validity. During the CMDR process, they can continue to manufacture, import, export, distribute and/or sell the product. The issued CMDN and proof of payment for CMDR will be provided during importation and/or bidding requirements.
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.
5. For the FDA to properly identify that the application submitted was for the CMDR of the expired CMDN, the MAH/applicant shall provide a letter stating that the application is from CMDN to CMDR and to attach the copy of the approved CMDN.

For more information, refer to the following links:

FDA-Circular-No.2020-001-A

FDA-Circular-No.2024-003

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