Class B, C, and D medical devices that were not included in the list of registrable medical devices based on FC No. 2020-001-A could continue to be manufactured, imported, exported, distributed, transferred, sold, or offered for sale without a CMDN until March 31, 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 as part of the bidding requirements.

In the previous amendment, FC 2021-002-B, this application route was supposed to close last 31 March 2023. However, now with the extension and regulatory flexibility, it gives medical device companies more time to comply with the requirements of the ASEAN CSDT format for the affected devices. At the same time, it also decreases the risk of shortage of these products in the market and minimizes potential negative effects to the health care system had the initial schedule been followed.

Under the current amendment version, applications for CMDN for Class B, C, and D medical devices covered under this circular shall be accepted until March 31, 2024. Receiving of applications for CMDN for these medical devices shall cease starting April 1, 2024. Companies may opt to apply for CMDR instead of CMDN for their products prior to this date. All manufacturers, traders, exporters, importers, and distributors shall apply for CMDR for Class B, C, and D medical devices covered under this Circular starting April 1, 2024.

Beginning April 1, 2024, the manufacture, importation, exportation, distribution, transfer, sale, or offering for sale of all Class B, C, and D medical devices covered under this Circular without a CMDN/CMDR or with a pending application for a CMDN/CMDR shall be prohibited.

Marketing authorization holders (MAH) with an expiring CMDN for Class B, C, and D medical devices shall apply for a CMDR at least six (6) months prior to its expiration. While the CMDR is in process, the MAH may continue to manufacture, import, export, distribute, and/or sell the product. The issued CMDN and proof of application for a CMDR shall be provided at the point of entry and/or as part of the bidding requirements.

Actions for affected Class B, C, and D medical devices

Important dates

Cutoff date for manufacture, import, export, distribution, transfer, sale, or offer for sale without CMDN

31 March 2024

Deadline of application for CMDN

31 March 2024

Termination of receiving applications

1 April 2024

Enforcement of the CMDR application

1 April 2024

Prohibition of manufacture, importation, exportation, distribution, transfer, selling, or offering for sale of medical devices without CMDN/CMDR or with pending application for CMDN/CMDR

1 April 2024

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References:
https://www.fda.gov.ph/fda-circular-no-2021-002-c-guidelines-on-the-regulatory-flexibility-for-class-b-c-and-d-medical-devices/

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