Prequalification Assessment and Change Assessment Target Deadlines - Prequalification of in Vitro Diagnostics
(2017; 10 pages)

Resumen

WHO Prequalification of In Vitro Diagnostics (IVDs) undertakes a comprehensive quality assessment of individual IVDs through a standardized procedure aimed at determining if the product meets WHO prequalification requirements1. Once a product is prequalified, WHO undertakes an assessment of all reportable changes that are made to the product to ensure that they continue to meet WHO prequalification requirements.

Each step of the prequalification assessment and change assessment process should be completed within defined target deadlines which have been set with the aim of expediting the prequalification assessment and facilitating access to quality IVDs.

This document outlines the:

  • target deadlines and deadline extensions for the abridged and full assessment pathways for an IVD under WHO prequalification assessment;
  • target deadlines and deadline extensions for assessment of changes to prequalified IVDs; and
  • process for requesting deadline extensions.

This document provides manufacturers with detailed information on target deadlines for the WHO prequalification assessment and change assessment.

 
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