WHO Pilots Faster Pre-Qualification Procedure For IVDs
This article was originally published in SRA
Executive Summary
The World Health Organization is planning to adopt a faster process for verifying the performance of IVDs submitted under its pre-qualification program. The new process, which is to be piloted later this year and officially launched in January 2017, is expected to result in shorter assessment timelines and a faster pre-prequalification decision for IVD sponsors1.