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