Overview of the WHO Prequalification of in Vitro Diagnostics Assessment. Version 8. Geneva: World Health Organization; 2018 - WHO Prequalification of in Vitro Diagnostics
(2018; 28 pages)

Abstract

This document has been prepared to provide manufacturers with an overview of the WHO process for prequalification assessment of IVDs (the prequalification assessment process). Manufacturers wishing to apply for WHO prequalification of their product(s) should read this document before applying, so that they can be aware of and prepared for all stages of the prequalification assessment process.

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 full prequalification assessment process includes the following components:

  • review of a product dossier;
  • performance evaluation including operational characteristics;
  • inspection of manufacturing site(s); and
  • labelling review.

The abridged prequalification assessment includes the following components:

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

Products submitted for prequalification assessment that meet, as determined by WHO, the WHO prequalification requirements are included in the WHO list of prequalified IVDs. The duration of the validity of the prequalification status of a product is dependent on the manufacturer’s fulfilment, within the applicable deadlines, of its post-qualification obligations and requirements, including:

  • prequalification commitments;
  • annual reporting;
  • reporting of changes;
  • post-market surveillance obligations;
  • receiving re-inspection; and
  • ongoing compliance with WHO prequalification technical specifications.

The findings of WHO prequalification are used to assess the safety, quality and performance of commercially available IVDs for the purpose of providing guidance to interested United Nations (UN) agencies and WHO Member States in their procurement decisions.

 
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