Abridged Prequalification Assessment - Prequalification of in Vitro Diagnostics
(2017; 11 pages)

Abstract

World Health Organization (WHO) prequalification of in vitro diagnostics (IVDs) is coordinated through the department of Essential Medicines and Health Products. Focus is placed on IVDs for priority diseases and their suitability for use in resource-limited settings.

WHO prequalification of IVDs is a comprehensive quality assessment of individual IVDs through a standardized procedure aimed at determining whether the product meets WHO prequalification requirements.

The abridged prequalification assessment includes the following components:

  • performance evaluation including operational characteristics;
  • manufacturing site inspection of abridged scope; and
  • labelling review.

This document should be read in conjunction with the “Overview of the WHO prequalification of in vitro diagnostics assessment” document PQDx_007.

 
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