Charmaine Roson - Philippines

“Medical Device manufacturers need to notify and get approval from the Philippines FDA should they need more time to exhaust old labels or if they will be over-labeling.”

Charmaine Roson
Principal Consultant
Asia Actual Philippines

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Philippines FDA Provides Guidance for CMDN to CMDR Medical Device’s Labeling

Published: May 7th, 2024

On April 5th, the Center for Device Regulation, Radiation Health, and Research (CDRRHR) clarified some of the requirements for CMDR medical device labeling in the Philippines. At the Kapihan (dialogue), several topics were discussed including plans for IVD Administrative Order release, new retailer requirements, and clarifications regarding the extension of regulatory flexibility for non-registrable medical devices. The complete meeting minutes can be found here.

CMDN to CMDR Labeling

To help clarify industry concerns, the CDRRHR provided more information on how manufacturers and local distributors can maintain compliance during the CMDN to CMDR transition. Labeling applied to medical devices that have been approved under Certificate of Medical Device Notification (CMDN) but are now under a Certificate of Medical Device Registration (CMDR) will need to reflect this change. It is recommended that manufacturers and/or license holders ensure that their local distributor(s) are compliant with this medical device labeling change in the Philippines. If compliance with labeling changes needs to be delayed then manufacturers need to notify the CDRRHR.

In case the distributor still has some stocks with old labels that need exhausting, the CDRRHR will need to be informed by the manufacturer with a letter to request for exhaustion of the medical device labeling to ensure that there are no issues with the FDA’s post-market surveillance team later on. Once the CMDR is released, the FDA must approve instances of over-labeling prior to distribution or importation. Additionally, if the registration number is machine printed, over-labeling is also allowed.

Current CMDN and CMDR Requirements

Initially, non-notified Class B, C and D medical devices (ones not listed in FDA Circular No. 2021-001-A) were required to have an initial CMDN in place by April 1st, 2022, to be followed by a more extensive CMDR at renewal. At this time, this requirement has been extended to September 2024 and more information on the current transition status can be found here.

Any Class B, C and D medical devices that are not included in Circular No. 2021-001-A without CMDN can still be imported/distributed using a local company’s License to Operate (LTO) until September 30, 2024. Manufacturers can also choose to submit a CMDN application ahead of this deadline if they should choose to do so. After September 30, 2024, all non-Registrable products without a CMDN will need a CMDR to be imported.

Conversely, companies with Class B, C and D Medical Devices listed in Circular 2021-001-A, must apply for a Certificate of Medical Device Registration (CMDR) prior to importation.

All Class A medical devices require a CMDN.

Grow With Us

Please contact us if you have questions regarding the new regulations and/or are interested in registering your product in the Philippines.

Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asia markets through independent license holding, direct fulfillment, and a variety of sales channel support services.

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