On August 2, 2024, the Food and Drug Administration (FDA) released an advisory regarding the implementation guidelines for a platform for submitting CMDN applications. FDA is currently developing the FDA eService’s Portal System – an online platform for a streamlined initial application of a Certificate of Medical Device Notification (CMDN). As part of this plan, the platform’s pilot implementation is available through the e-services portal system website and accessible through the link: eservices.fda.gov.ph.
The scope of the pilot implementation is as follows:
| Target Participants | Licensed Medical Device Establishments with Office Address within National Capital Region (NCR) |
|---|---|
| Type of CMDN Application | Initial Application |
| Type of Medical Device | A. All Class A medical devices |
| B. Class B, C and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-001-A | |
| Fees to be paid for each application | Based on the current issuance on Fees and Charges (Reference: DOH Administrative Order No. 50 s. 2001) |
| Start of Pilot Implementation | 12 August 2024 |
| End of Pilot Implementation | 11 October 2024 |
Additional notes from this pilot implementation are as follows:
- All applications must be filed online, and account and password creation are no longer required.
- Existing CMDN applications via the e-Portal system are already being processed and are not required to be re-applied in the eService’s portal system. but a separate fee will be charged for applicants wish to apply using the eService’s Portal System. Previous payments for applications filed in the ePortal System will not be credited for new applications.
- Applicants will follow the procedure for filing and checking application status as stated by the advisory’s Annex A and B, respectively.
- The FDA will issue detailed guidelines for nationwide implementation of the initial application of CMDN through the eService’s Portal System based on the results of this pilot implementation.
For further information, refer to the following link: https://bit.ly/3YC8uT6.
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