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Philippines: Regulatory Flexibility Extension for the Unlisted Class B, C, and D Medical Devices in the Registrable Medical Devices List

The Philippines FDA (PFDA) extended the Regulatory Flexibility period further through the issuance of FDA Circular No. 2024-003 on 26 March 2024. The extension is intended to assist medical device industries with ample time in preparing the technical documentary requirements to apply for a Certificate of Medical Device Registration (CMDR) for Class B, C, and D that are not listed in the registrable medical devices list.


Referring to the previous circular (FDA Circular 2021-002-C), PFDA has extended the flexibility period for industry players to manufacture, import/export, distribute, transfer, sell, or offer for sale without CMDN until 31 March 2024. PFDA took quick action to provide a further extension to avoid market disruption while assisting industries in complying with the ASEAN CSDT requirements in applying for CMDR.


Here are the latest regulatory flexibility guidelines



The Market Authorization Holders (MAHs) with valid CMDN of Class B, C, and D medical devices were advised to apply for CMDR within its validity period to ensure smooth continuous availability of market authorization. A copy of CMDN shall be attached with the statement letter to state that the application is from CMDN to CMDR.


MAHs may use the issued CMDN and payment proof for CMDR application at the point of entry and/or as part of bidding requirements during the application process to continue the business activities (manufacture, import, export, distribute, sell the products). Hence, this circular effectivity automatically modified, repealed, and/or revoked the FDA Circular 2021-002-C.


You may refer to our article about the previous regulatory flexibility extension here

 

 

Contact us at info@arqon.com for more information.

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