The Food and Drug Administration (FDA) of the Philippines has issued FDA Circular No. 2025-007, providing detailed guidance on the submission of initial Certificate of Medical Device Notification (CMDN) applications, monitoring application status, and downloading approved CMDNs via the FDA eServices Portal System.
This Circular formalizes the transition of CMDN initial application processing from the legacy ePortal System to the upgraded eServices Portal System, in response to persistent system limitations, technical failures, and integration challenges associated with the older platform.
Read the full Circular:
https://www.fda.gov.ph/wp-content/uploads/2025/12/FDA-Circular-No.2025-007.pdf
Purpose of the Circular
- To shift the filing of initial CMDN applications for Class A medical devices from the ePortal System to the eServices Portal System.
- To improve stability, reliability, and efficiency of regulatory submissions.
- To provide guidance on application filing, status verification, and retrieval of approved CMDNs.
- To support digital modernization efforts and enhance client experience.
Key Highlights
Transition to the eServices Portal System
- Initial CMDN applications for Class A medical devices must now be filed exclusively through the FDA eServices Portal System: https://eservices.fda.gov.ph/
- The legacy ePortal System will be deactivated for filing CMDN initial applications upon the Circular’s effectivity.
Scope of Applications
- Renewal and variation CMDN applications are not included in this transition and must continue to be submitted via email to the Food and Drug Action Center (FDAC) at fdac.letters@fda.gov.ph until separate procedural guidelines are issued.
Handling of Ongoing Applications
- CMDN applications already filed through the ePortal System before effectivity will continue to be processed in that system until completion.
Access Features of the eServices Portal
- Users are no longer required to create an account or password to access the eServices Portal.
- The CMDN Number format remains unchanged: CDRRHR-CMDN-YYYY-XXXXXX
Implications to Clients
Clients can expect significant improvements resulting from the transition to the eServices Portal System, including:
- Reduced technical issues and system downtime
- More predictable and efficient processing timelines
- Real-time status visibility for active applications
- Convenient electronic downloading of approved CMDNs
- Lower administrative burden and smoother submission experience
This initiative aligns with the FDA’s ongoing digitalization efforts and its commitment to client-centered regulatory service delivery, particularly for low-risk (Class A) medical devices.
Effectivity
The Circular will take effect 15 days after publication in the Official Gazette or a newspaper of general circulation, and upon filing with the University of the Philippines Law Center, Office of the National Administrative Register.
For inquiries or support regarding medical device regulatory requirements in the Philippines, please contact sales@andamanmed.com.
