The Philippines Food and Drug Administration (FDA) has issued Advisory No. 2021-3084, with details regarding the abridged route for the registration of medical devices in the Philippines, in November 2021.
The introduction of this advisory is to aid the registration process of medical devices that have prior approval in any ASEAN member country, which will make the registration process faster and easier. Approval obtained from regulatory authorities in other countries (not in ASEAN) will not be considered for this abridged route.
Applications for Certificate of Medical Device Notification (CMDN) or Certificate of Medical Device Registration (CMDR) for medical devices in classes B, C, and D can be done under this abridged route. The approval for the medical device must have been the result of application (full evaluation) via the Common Submission Dossier Template (CSDT).
The company will still need to submit relevant documents, such as legal and technical documents, to comply with the requirements. This is stipulated in Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on The ASEAN Harmonized Technical Requirements”.
More details can be found in “FDA Advisory No. 2021-3084, November 2021”: https://www.fda.gov.ph/wp-content/uploads/2021/11/FDA-Advisory-No.2021-3084.pdf