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 31, 2024. . (FDA Circular No. 2021-002)
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.
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.
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.
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