Rwanda medical device regulatory resources

DHT/GDL/024 section 1.10.1 states that an application for registration or notification shall be processed within twenty (20) working days for the notification procedure; the registry's unit vocabulary is days, weeks and months, so the figure is recorded as 20 days and the working-day basis is recorded here.

Clock stops apply: where the Authority requests additional data, the applicant has ten (10) working days to supply it in the notification procedure, and the assessment resumes from the requested supplement.

A notification letter is valid for three (3) years, against five (5) years for a registration certificate.

Dossiers are scheduled first in, first out once the requirements are met, so elapsed time depends on the queue as well as the clock.

DHT/GDL/024 section 1.10.1 states sixty (60) working days for the abridged assessment procedure; recorded as 60 days with the working-day basis noted here because the registry's unit vocabulary is days, weeks and months.

Where additional data is requested, the applicant has twenty (20) working days to supply it and the clock stops in the meantime.

The abridged route rests on the Authority's reliance power in Article 16 of the Regulations Governing the Registration of Medical Devices including In Vitro Diagnostics, and on the Guidelines on Reliance for Regulatory Decision-Making (ODG/RAHC/GDL/001 Rev 3), which state a 90-working-day reliance pathway for marketing authorisation excluding clock stops.

For a device assessed on the abridged route, quality-system compliance of the manufacturing site is confirmed by desk review rather than an on-site inspection, although the Authority may still inspect.

DHT/GDL/024 section 1.10.1 states one hundred eighty (180) working days for the full assessment procedure; recorded as 180 days with the working-day basis noted here because the registry's unit vocabulary is days, weeks and months.

Where additional data is requested, the applicant has sixty (60) working days to supply it and the clock stops in the meantime.

A device that holds no WHO prequalification, no SRA approval, no WHO Listed Authority registration and no EAC joint dossier assessment ordinarily runs the full procedure; a China NMPA certificate alone does not open the abridged route.

This clock is the Rwanda FDA device assessment clock. It is not the RURA type approval clock, which is a separate procedure, and it is not an import clearance clock.