DRAFT FOR COMMENTS: ABRIDGED PROCESSING OF APPLICATION FOR MEDICAL DEVICES
The Philippines Food and Drug Administration (FDA) seeks comments from the Medical Device Industry regarding new draft guidelines that could provide faster registration processing and approval should the medical device qualify for the abridged route.
Advisory 2021-3084 was issued last November 18, 2021: Abridged Processing of Application for registration/notification of medical devices approved by the National Regulatory Authority of any Association of Southeast Asian Nations (ASEAN) Member Country. However specific guidelines were not mentioned.
This draft FDA circular aims to provide guidelines on the abridged processing of applications for registration and notification of medical devices with product approval issued by the NRA of any ASEAN member country under the AMDD-CSDT requirements.
This applies to medical devices covered under AO 2018-002 that are to be imported, distributed, and sold in the Philippines. In-vitro diagnostics and refurbished medical devices are not covered by this circular.
The key points of the guidelines are:
- The abridged processing is applicable if the medical devices being applied to FDA have been approved by the reference NRA of the ASEAN member country.
- Certificate of Product Registration (CPRs) issued based on abridged approval in other countries outside the ASEAN is not qualified in the FDA abridged processing.
- The FDA abridged processing is only applicable to Class B, C, and D medical devices.
- The applicant shall submit complete legal and technical requirements that are the same as those submitted to the reference NRA of the ASEAN member country where the Certificate of Product Registration (CPR) was issued. In addition, a notarized application form shall be submitted.
- An order of payment will be issued to applications that complied with the pre-assessment.
- The submitted Certificate of Product Registration (CPR) shall be verified by CDRRHR from the reference NRA of the ASEAN member country.
All comments can be sent to [email protected] The deadline for submission of comments is on 25 April 2022. The full draft of this regulation can be accessed at: https://www.fda.gov.ph/draft-for-comments-abridged-processing-of-application-for-registration-notification-of-medical-devices-approved-by-the-national-regulatory-authority-of-any-asean-member-country/