Post-market Surveillance of in Vitro Diagnostics
(2015; 63 pages) [French] [Russian]

Abstract

The World Health Organization (WHO) Prequalification of In Vitro Diagnostics Programme is coordinated through the department of Essential Medicines and Health Products. The aim of the WHO Prequalification of In Vitro Diagnostics Programme is to promote and facilitate access to safe, appropriate and affordable in vitro diagnostics (IVDs) of good quality in an equitable manner. Focus is placed on IVDs for priority diseases and their suitability for use in resource-limited settings.

The WHO Prequalification of In Vitro Diagnostics Programme undertakes a comprehensive assessment of IVDs through a standardized procedure aimed at determining if the product meets WHO prequalification requirements. The prequalification assessment process includes three components:

• Review of a product dossier;

• Laboratory evaluation of performance and operational characteristics; and

• Manufacturing site(s) inspection.

This document pertains to the objectives and processes of the post-market surveillance for IVDs that are within the scope of the WHO Prequalification of In Vitro Diagnostics Programme, i.e. WHO prequalified IVDs. It describes the measures that should be taken to ensure the ongoing compliance of WHO-prequalified IVDs with WHO prequalification requirements for safety, quality and performance after they are placed on the market. Therefore, manufacturers, users, and regulators of WHO prequalified IVDs are suggested to follow this guidance.

However, in light of the current lack of adequate post-market surveillance in many settings, the principles of this guidance may also be applied to other IVDs (either analyte or format) that fall outside the scope of the WHO Prequalification of In Vitro Diagnostics Programme.

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