Technical Guidance Series 1 (TGS–1) for WHO Prequalification of in Vitro Diagnostic Medical Devices: Standards Applicable to the WHO Prequalification of in Vitro Diagnostic Medical Devices
(2017; 33 pages)

Abstract

The WHO Prequalification Programme is coordinated through the Department of Essential Medicines and Health Products. WHO prequalification of in vitro diagnostics (IVDs) is intended to promote and facilitate access to safe, appropriate and affordable IVDs of good quality in an equitable manner. The focus is on IVDs for priority diseases and their suitability for use in resource-limited settings. The WHO Prequalification Programme undertakes a comprehensive assessment of individual IVDs through a standardized procedure that is aligned with international best regulatory practice. It also undertakes post-qualification activities for IVDs to ensure their ongoing compliance with prequalification requirements.

This document identifies standards and guidance that contains valuable information on a range of issues that are encountered in the manufacture, verification, and validation of in vitro diagnostics medical devices (IVDs). This document should not be taken as a prescriptive checklist of all references, but those identified are most widely applicable to the IVDs that are assessed for WHO prequalification. The tables reference international standards, global , national, and regional and industry standards and regulatory authority guidelines. The tables will be updated as more standards and guidance are published, updated or superseded. In addition, there are links to useful websites from standards organizations and mature regulatory authorities that reference additional standards and guidance documents to consider.

The purpose of this document is to:

• provide IVD manufacturers and regulators of IVDs with references to standards and guidance that are applicable to IVDs ; and

• encourage manufacturers to use appropriate international standards when demonstrating the IVD conforms to relevant essential safety and performance principles.

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