Collaborative procedure between the WHO and NRA's in the assessment and accelerated national registration of WHO-prequalified IVD's - Annex 4

Overview

National assessment of applications for registration (marketing authorization) of in vitro diagnostics (IVDs) is a key regulatory process that enables national regulatory authorities (NRAs) to evaluate and monitor the quality, safety and performance of IVDs. 

WHO Team
Technical Standards and Specifications (TSS)
Number of pages
34
Reference numbers
WHO Reference Number: WHO/BS/2020.2397