Philippines: FDA Issued FDA Circular 2022-008: Guidelines For The Abridged Processing Of Application For Registration Of Medical Devices Approved By The National Regulatory Authority Of Any ASEAN Member Country
On 27 September 2022, the Philippines FDA issued FDA Circular No. 2022-008 which aims to provide guidelines on the abridged processing of application 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. The circular shall not cover medical devices with issued Certificate of Product Registration (CPR) based on abridged approval in other countries outside the ASEAN as well as in vitro diagnostics and refurbished medical devices.
Summary of the guidelines are outlined below:
A. Medical device applications with product approvals from the NRA of any ASEAN member country under the AMDD-CSDT can qualify for the 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.
B. FDA reserves the right to forego abridged processing, as may be warranted, in case of any of following circumstances:
- Receipt of negative report on the medical device from other countries;
- When there are conflicting views or assessments from NRAs of other ASEAN countries on the same medical device; and
- Other circumstances that may entail the FDA’s careful evaluation of the medical device applications for authorization.
C. Applicant 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 CPR was issued. The Notarized Application Form shall indicate the following statements:
- Attestation from applicant that the product details and CSDT technical documentation are exactly the same as those filed/approved by the reference NRAs; and
- Acknowledgement and concurrence that in the event that there is an unauthorized change in the product details and CSDT documentation:
- The FDA shall automatically suspend the LTO and/or CMDR of the product;
- The applicant shall voluntarily recall the product from the market in accordance with the FDA guidelines on product recall; and
- The applicant shall indemnify and/or hold FDA free and harmless against any and all third-party claims and/or actions pertaining to the above unauthorized changes.
D. The application shall still be subjected to pre-assessment during which the FDA through the CDRRHR shall check on the completeness of the legal and technical requirements. Only those applications that complied with the pre-assessment shall be issued an Order of Payment.
E. The legal requirements shall undergo compliance evaluation while the technical requirements shall not be subjected to technical review by the CDRRHR except for the labeling requirements.
F. The CDRRHR shall verify the submitted CPR from the reference NRA.
G. The labelling requirements shall be evaluated based on those prescribed in AO No. 2018-0002 and any subsequent future labeling issuances.
H. The turnaround time for the abridged process shall be thirty (30) working days which shall start upon receipt of the proof of payment by the CDRRHR.
The circular shall take effect fifteen (15) days after its publication in the Official Gazette or in any newspaper of general circulation and upon filing with the University of the Philippines Law Center- Office of the National Administrative Register.
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