Philippines: PFDA Issued a Draft Guidance Documents on CMDN Initial Application via FDA eServices Portal System
PFDA issued a circular draft for comments regarding the guidelines on the use of the eServices portal system for the initial application of Certificate of Medical Device Notification (CMDN) in line with the PFDA’s goal of delivering efficient government services. Currently, CMDN applications are transacted via the ePortal System. Migrating the mentioned transaction to the eServices will benefit from the system’s improvements.
The Circular shall cover the authorizations of the following:
- All Class A medical devices
- Class B, C, and D medical devices not included in the list of registrable medical devices in the FDA Circular No. 2021 – 001 – A.
Furthermore, this Circular will not cover renewal and variation applications.
No account or password creation is required to access the eServices platform. Upon effectiveness of the circular, initial applications for CMDNs shall be filed through the eServices via the link: https://eservices.fda.gov.ph/. In addition, applications made via ePortal will be deactivated, however, ongoing applications still will be processed. Furthermore, PFDA clarifies that the current format of CMDN number will still be followed (CDRRHR – CMDN – YYYY – XXXXXX).
CMDN application requirements still follows DOH Administrative Order No. 2018 – 0002. The procedure for the submission process in the eServices is outlined in Annex A of this circular whereas the application status can be checked following Annex B.
Annexes for the advisory can be found below:
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