Collaborative registration procedure (CRP) for in vitrodiagnostics (IVDs) – Information note

Overview

The availability of quality assured IVDs is a core element of a functional healthcare system. National regulatory and product selection processes have been identified as one of the barriers slowing down access to priority quality assured IVDs in many WHO Member States. Although WHO prequalified IVDs are assessed according to international standards, unclear pre-market registration processes, repetitive performance evaluations and lengthy product selection procedures result in a delayed market entry of products which have been assessed and found compliant with WHO prequalification requirements.

WHO is committed to supporting National Regulatory Authorities in optimizing available resources, applying reliance principles where possible, and facilitating access to quality assured health products.