Non-Notified Products can be Imported without a CMDN through March 2022

With the release of Circular No. 2021-002-A, “Addendum to FDA Circular No. 2021-002” on August 8th, the FDA formalized new guidelines for the final transition phases in the Philippines for the pre-market registration requirement for all medical devices.

Now, during the grace period, Class B, C, and D medical devices that are not included in the specified list in Circular No. 2021-001-A may continue to be manufactured, imported/exported, distributed, and/or sold without an initial Certificate of Medical Device Notification (CMDN) until March 31, 2022. The importers of these devices are simply required to have a valid License To Operate (LTO) for importation and tenders. Non-notified devices not yet on the market in the Philippines, must first apply for and be issued a CMDN for importation and sales in the Philippines.

Grace Period Deadline

The new grace period will end on April 1, 2022, and after that, a CMDN or a pending application will be required for manufacturing, importing, distributing, and/or selling in the Philippines. The application window for a CMDN for Class B, C, and D devices is until March 31, 2023 and will end on April 1, 2023, after which a more involved Certificate of Medical Device Registration (CMDR) will be required. CMDNs with validity beyond April 1, 2023, will remain valid until their expiry. Three (3) months prior to the expiration of the CMDN, the company will need to apply for a CMDR and the issued CMDN and proof application for CMDR shall be provided at the point of entry and/or part of bidding requirements until the CMDR is approved.

From April 1, 2023, manufacturers of Class, B, C, and D devices not already registered under the CMDN route, will need to apply for a CMDR.

Regarding Certificates of Exemption (COEs), any that were issued from February 25, 2014 will be valid until March 31, 2022 to facilitate applications for CMDNs.

The Addendum will take effect 15 days after publication.

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