Philippine FDA seeks feedback on expedited evaluation of medical devices

The Philippine Food and Drug Administration (FDA) is seeking feedback on the expedited review of medical devices that already have been authorized by another national regulatory authority (NRA) in the Association of Southeast Asian Nations (ASEAN).

In line with World Health Organization advice about the benefits of relying on other regulatory agencies, FDA has set out draft guidelines on the abridged processing of fillings for registration and notification of certain medical devices. The expedited pathway will apply to products approved by the NRA of an ASEAN member country under the requirements of the ASEAN Medical Device Directive Common Submission Dossier Template (AMDD-CSDT).

“The applicant shall submit complete legal and applicable technical requirements when applying for registration/notification of medical devices. The technical requirements to be submitted shall be the same as those submitted to the reference NRA of the ASEAN member country where the Certificate of Product Registration (CPR) was issued,” the guidelines state.

FDA is proposing that applicants attest that the CSDT technical documentation is identical to that filed with the other ASEAN NRA and acknowledge that the agency may automatically suspend the product if there is an unauthorized change in its details and documentation. Unauthorized changes also may trigger voluntary recalls. FDA is indemnified against third-party claims relating to unauthorized changes under the draft guidenlines.

Submissions for expedited review will undergo a pre-assessment process, during which FDA will check the completeness of the legal and technical requirements. FDA will only issue an order of payment after determining that an application is complete. The agency will verify the submitted CPR from the reference NRA of the ASEAN member country.

CPRs issued based on an abridged approval in countries outside the ASEAN are ineligible, and the pathway is only open to Class B, C and D medical devices. FDA is reserving the right to refuse expedited review if it receives a negative report about the medical device from other countries, ASEAN NRAs have conflicting views about a product or because it otherwise thinks a full evaluation is needed.

FDA is accepting feedback on the proposal until 25 April. RAPS.org