WHO/BS/2020.2399 collaborative procedure between the WHO and National Regulatory Authorities in the assessment and accelerated national registration of WHO prequalified IVDs

Overview

This Collaborative Procedure has been developed based on the above-mentioned considerations to enhance timely access to WHO prequalified products in countries, to ensure “sameness” can be demonstrated, that the product in countries is the same as the one which is WHO prequalified and to provide a model for regulatory information exchange between countries.