THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A medical devices, thereby streamlining regulatory compliance for businesses in the medical industry.
Starting on March 10, 2025, all businesses dealing with Class A medical devices must submit CMDN applications exclusively through the eServices Portal System.
The FDA issues a CDMN to confirm that a medical device meets safety, quality, and performance standards before it can be legally sold or distributed in the country.
Class A medical devices are those considered to have the lowest risk to patients and users. It includes non-powered wheelchairs, elastic bandages, surgical masks, digital thermometers, and basic wound dressings.
The online application process follows a pilot run, as stated in FDA Advisory No. 2024-1089 and its amendment, FDA Advisory No. 2024-1089-A, released on Aug. 2, 2024, and Nov. 29, 2024, respectively.
The pilot phase aimed to test the efficiency and user-friendliness of the eServices Portal System.
The FDA improved the digital platform based on feedback from users during the trial phase, making it easier to navigate and more efficient for applicants.
In its current form, the system will only process CMDN applications for Class A medical devices, based on Administrative Order No. 2018-0002 which sets the guidelines for the regulation of medical devices in the Philippines.
Application fees will follow the FDA’s latest fee guidelines, which are periodically updated to align with administrative costs and regulatory requirements.
The previous ePortal System for CMDN applications will be shut down, signalling the full transition to the new system.