Submission Procedure – Abridged Assessment of an IVD
WHO prequalification of IVDs is a comprehensive quality assessment of individual IVDs through a standardized procedure aimed a t determining whether a product meets WHO prequalification requirements.
An abridged prequalification assessment includes the following components:
- review of an abridged product dossier;
- performance evaluation, including operational characteristics;
- manufacturing site(s) inspection; and
- labelling review