Charmaine Roson - Philippines

With this extension from the CDRRHR, Non-Notified product categories not listed in Circular No. 2021-001-A can continue to be imported with only a local License to Operate (LTO)

Charmaine Roson
Principal Consultant
Asia Actual Philippines

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Philippines FDA Extends CMDN Deadline to 2024

Published on: March 31st, 2023

The Center for Device Regulation, Radiation Health and Research (CDRRHR) of the Philippines FDA has announced that the deadline for Certificate of Medical Device Notification (CMDN) applications for non-Notified Class B, C and D Medical Devices will be extended to March 31st, 2024.

In the meantime, these devices may be imported and sold on the Philippines market by any local company with a valid and appropriately scoped License to Operate issued by the Philippines FDA.

Then from April 1, 2024, importation of all class B, C and D medical devices without CMDN or CMDR or at least a pending CMDN application will be prohibited. The notification can be read here.

Class B, C and D products specified in Circular No. 2021-001-A must still have a Certificate of Medical Device Registration (CMDR) in place, and all Class A devices must have a CMNN in place prior to importation and marketing in the Philippines.

The CDRRHR is also now accepting CMDR applications for non-Notified risk class B, C and D devices in case manufacturers or their local authorized agents wish to jump ahead to full compliance with the new Rules and avoid extra half steps available through the transition period.

Manufacturers with expiring Class B, C and D CMDNs will need to renew with a CMDR application submitted six months prior to the expiration of the CMDN.

The above information is covered in FDA Circular No. 2021-002C. For a consultation to understand how these changing conditions affect market access for your product portfolio in the Philippines, please contact us here.

You can also find more information on the Philippines medical device registration page here.

CMDN Extension Deadline Now 2024 for Non-Notified Devices

This announcement comes after prior regulation implemented in 2019 where Class A medical devices were required to obtain a CMDN while, a specific list of devices, referred to as “Notified” Class B, C and D medical devices were required to obtain a CMDR prior to being imported and achieve market access in the Philippines.

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.

This original deadline was first delayed to April 1st, 2023. Information about the prior extension, which occurred in April of 2022, can be found on our website here.

Note: Home country approval, or reference country approval is required for the registration or notification of all classes of devices.

Products that Currently Require a CMDR or CMDN

All 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 March 31, 2024. Manufacturers can also choose to submit a CMDN application ahead of this deadline if they should choose to do so.

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.

For more information on the registration process in the Philippines, please click here.

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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