Snapshot

The Registration of In-Vitro Diagnostic Devices (Abridged Review) pathway has been developed by the of Rwanda.

This pathway can be used where In-vitro diagnostic devices (Classes B-D). .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is After receiving an application requesting registration, the Authority shall proceed with the screening of the dossier for completeness. In the event that the dossier is incomplete, it will not be scheduled for assessment, and the applicant will be notified within thirty (30) working days and requested to comply with requirements in writing. Devices under abridged assessment shall not undergo the screening process. In case of a positive outcome during the screening, the application will be scheduled for assessment according to the First in First out (FIFO) rules. Priority assessment may be granted where the device is intended for diagnosis of rare disease conditions or in the case of an emergency situation. An IVDD dossier is reviewed by two assessors to provide scientific and regulatory oversight regarding the quality, safety and performance of the IVDD under assessment. After a thorough dossier assessment, a final dossier assessment report shall be presented to the Authority’s Peer Review Committee (PRC) before making final decisions for granting or rejecting market authorization of the IVDD. In the event, that there are safety, quality or performance issues to be resolved as per the decision of the PRC, the application shall remain pending until the resolution of the raised issues. If the applicant fails to provide the required data within ninety (90) calendar days, the product application shall be considered as withdrawn. TIMELINES FOR IN VITRO DIAGNOSTICS REGISTRATION/NOTIFICATION: In Vitro Diagnostics Device dossiers shall be scheduled for assessment according to the First in First out (FIFO) basis upon compliance with the requirements. A new application for registration shall be processed within: - Thirty (30) calendar days for the notification procedure; - Ninety (90) calendar days for the abridged assessment procedure; - Nine (9) months for the full assessment procedure. .