Philippine FDA announced FDA Circular No.2024-003 on March 26, 2024. This issuance extended the dates for the application of a CMDN and CMDR for all Class B, C and D medical device that are not included in the list of registrable medical devices based on FC No. 2020-001-A. All 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 may continue to be manufactured, imported, exported, distributed, transferred, sold or offered for sale without CMDN until 30 September 2024. The License to Operate of the medical device establishment shall be provided at the point of entry (presented to the Bureau of Customs officer) and/or part of bidding requirement.
All manufacturers, traders, exporters, importers and distributors shall apply for CMDR for Class B, C and D medical devices covered under this Circular starting 1 October 2024. Beginning 1 October 2024, 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 / CMDR or without pending application for CMDN / CMDR shall be prohibited.
Market Authorization Holder (MAH) with valid CMDN for Class B, C and D medical devices shall apply for CMDR at anytime within its validity period to ensure continuous availability of market authorization during this transition.
Conversely, B, C, and D class medical devices specified in No.2021-001-A must still have a Medical Device Registration Certificate (CMDR), and all A class devices must have a CMDN before being imported and sold in the Philippines.
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