Philippines Extends Grace Period for Registration of Certain Medical Devices

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.