On 4 Decemberber 2023, the Philippines FDA released draft guidelines on the "Use of the Food and Drug Administration eServices Portal System for the Initial Application of a Certificate of Medical Device Notification (CMDN)" for public comments.
Certificate of Medical Device Notification (CMDN) – is the authorization issued to all class A medical devices and to the initial application of class B, C and D medical devices that are not included in the list of registrable medical devices based on FC No. 2021-001-A.
eServices Portal System – is an online application system designed by the FDA that aims to improve and streamline the digital application, processing, and issuance of FDA market authorizations.
Currently, the Philippine Food and Drug Administration (FDA) is in discussion to establish guidelines for submitting a Certificate of Medical Device Notification (CMDN) via an online portal, and FDA guidelines cover changing from the old ePortal system to the new eServices portal system.
This document aims to provide guidelines on the following:
A. Filing of initial application for a CMDN using the eServices Portal System
B. Checking of the status of the CMDN application
C. Downloading of the CMDN from the eServices Portal System
An initial application for a CMDN for a medical device shall follow the guidelines published in AO No. 2018-0002, entitled "Guidelines Governing the Issuance of an Authorization for a Medical Device based on ASEAN Harmonized Technical Requirements", or its subsequent amendments.
The process for filing the initial application for CMDN shall follow the guidelines provided in Annex A and the guidelines in Annex B of this circular should be followed when checking the application status and downloading the approved CMDN.
The Circular’s objectives, impact, and effectiveness will be evaluated within three (3) years of its implementation to determine if the Circular’s provisions still stand as lawful and enforceable.
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