Charmaine Roson - Philippines

“Even with the Philippines FDA extending the grace period, it’s still recommended that manufacturers seek registration at their earliest convenience.”

Charmaine Roson
Principal Consultant
Asia Actual Philippines

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Philippines Extends Grace Period for Registration of Certain Medical Devices

Published on: March 28th, 2022

Updated April 27th, 2022

On April 21, the Philippines FDA published the official Circular announcing an extension of the grace period for the mandatory registration of non-Notified class B, C, and D medical devices by 12 months.

With the release of the Circular, 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, 2023. The importers of these devices are simply required to have a valid License To Operate (LTO) for Customs clearance and public tender qualification.

It should be noted that the Philippines FDA currently accepts and processes applications; and will issue Certificates of Medical Device Notification for these devices during the grace period.  Further, the stated purpose of the extension is to ensure continued availability of devices already on the market; and so new non-Notified devices not yet on the market in the Philippines are technically still subject to pre-market approval.

Grace Period Deadline

After the new grace periods ends, an initial CMDN or a pending application will be required for manufacturing, importing, distributing, and/or selling no-Notified Class B, C, and D devices. Three (3) months prior to the expiration of the CMDN, the local agent 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.

For the latest information regarding the medical device registration process in the Philippines, click here.

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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today to see how new regulatory developments may affect your business in the Philippines.

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