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Guidance on Issuing of an Authorization for Med Device based on ASEAN Requirements - PhilippinesFDA

The Philippine Food and Drug Administration (FDA) released an addendum to circular (to FDA Circular No. 2021-002) on the transition to new ASEAN Harmonized Technical Requirements for medical devices, with an objective to provide guidelines for the transition period wherein the manufacturers, traders, and distributors/ importers/ exporters of medical devices covered by FC No. 2021-002 may apply for CMDN and may be allowed to manufacture, import, export, distribute, transfer, sell or offer for sale their medical device products pending the issuance of the CMDN Certificate of Medical Device Notification (CMDN).

These guidelines shall cover Class B, C, and D medical devices that are not included in the list of registrable medical devices based on FDA Circular No. 2020-001-A.

Starting 1 April 2022, only Class B, C, and D medical devices with issued CMDN or with a pending application for CMDN shall be allowed to be exported from the Philippines or manufactured, imported, distributed, transferred, sold, or offered for sale in the country.

All manufacturers, traders, exporters, importers, and distributors of Class B, C, and D medical devices shall secure a Certificate of Medical Device Registration (CMDR) starting 1 April 2023.

Check out the Addendum and the official notice for more detailed information.

Check this video on how to apply for a CERTIFICATE OF MEDICAL DEVICE NOTIFICATION via FDA Electronic Portal.

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