Philippines FDA issues Circular No. 2022-008 on 27th September 2022, aims to provide guidelines on the abridged processing of applications for registration of medical devices with product approval issued by the NRA of any ASEAN member country under the AMDD-CSDT requirements.
This Circular shall apply to Class B, C and D medical devices that are covered under AO No. 2018-0002, with product approval issued by the NRA of any ASEAN member country under the AMDD-CSDT requirements, and which are to be imported, distributed and sold in the Philippines. This issuance shall not cover medical devices with issued Certificate of Product Registration (CPR) based on abridged approval in other countries outside the ASEAN. Furthermore, in consonance with AO No. 2018-0002, this Circular shall not cover in vitro diagnostic and refurbished medical devices.
All applications for registration of medical devices approved by the NRA of any ASEAN member country under the AMDD-CSDT requirements shall have an abridged processing by the FDA through the Center for Device Regulation, Radiation Health, and Research (CDRRHR) provided that the medical device being applied to the FDA is the same medical device that has been approved by the said reference NRA.
Applicants shall submit complete legal and applicable technical requirements when applying for registration of medical devices. The technical requirements to be submitted shall be the latest and the same as those submitted to the reference NRA where the Certificate of Product Registration (CPR) was issued.
The turnaround time for the abridged process shall be 30 working days which shall start upon receipt of the proof of payment by the CDRRHR.
For more details regarding the submission conditions and process, as well as the documentary requirement, please refer to Circular No. 2022-008 at the following link:
https://www.fda.gov.ph/fda-circular-no-2022-008-abridged-processing-of-application-for-registration-of-medical-devices-approved-by-the-national-regulatory-authority-of-any-asean-member-country/”