The Philippine FDA has extended the deadline for applying for a Certificate of Medical Device Notification (CMDN) for Class B, C, and D medical devices not included on the list in FDA Circular No. 2020-001-A. This is a follow-up to the previous extension granted in March 2023.
The extension aims to ensure a smooth transition and uninterrupted availability of medical devices. It provides additional time for the industry to comply with the new ASEAN Common Submission Dossier Template (CSDT) requirements for CMDR applications.
Key highlights of FDA Circular No. 2024-003:
- All Class B, C, and D medical devices not listed as registrable under FC No. 2020-001-A are permitted for manufacture, import, export, distribution, transfer, sale, or offering for sale without CMDN until September 30, 2024.
- Acceptance of CMDN applications for these devices will halt on October 1, 2024.
- Starting October 1, 2024, all manufacturers, traders, exporters, importers, and distributors must apply for CMDR for Class B, C, and D medical devices covered by this Circular.
- Market Authorization Holders (MAH) holding valid CMDN for Class B, C, and D medical devices must apply for CMDR within its validity period to ensure continuous market authorization during this transition.
- When applying for CMDR, applicants must include a letter indicating the transition from CMDN to CMDR, along with a copy of the CMDN attached to the letter.
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