The Philippine Food and Drug Administration (FDA) has concluded the pilot implementation of the Certificate of Medical Device Notification (CMDN) application process through the eServices Portal System. This initiative, outlined in FDA Advisory No. 2024-1089, applied exclusively to applicants within the National Capital Region (NCR). The FDA has issued the following updates for stakeholders and the public:
Key Announcements
- Conclusion of the Pilot Program:
- The pilot program officially ended on November 29, 2024.
- Submission Deadline for CMDN Applications:
- Applicants from NCR were able to submit initial CMDN applications via the eServices Portal System until November 29, 2024, in compliance with the processes detailed in:
- Annex A: Submission of initial applications.
- Annex B: Reviewing application statuses.
- Applicants from NCR were able to submit initial CMDN applications via the eServices Portal System until November 29, 2024, in compliance with the processes detailed in:
- Processing of Applications Submitted During the Pilot:
- All CMDN applications submitted through the eServices Portal System on or before November 29, 2024, will be processed as per the established guidelines.
- Transition to ePortal System for CMDN Applications:
- Effective November 30, 2024, the eServices Portal System will no longer accept initial CMDN applications.
- All subsequent CMDN applications must be submitted via the ePortal System.
Next Steps for Stakeholders
If you are applying for a Certificate of Medical Device Notification:
- Ensure all applications are now redirected to the ePortal System starting November 30, 2024.
- Familiarize yourself with the submission guidelines provided in FDA Advisory No. 2024-1089 and its annexes.
Additional Information
For further details and comprehensive instructions, refer to the official advisory linked below:
FDA Advisory No. 2024-1089-A – CMDN Pilot Implementation Updates
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