Overview of WHO’s prequalification procedure for in vitro diagnostics
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World Health Organization
Abstract
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iv, 32 p.
Ensuring the quality, safety and performance of in vitro diagnostics is essential for reliable disease detection and informed public health decision-making, particularly in resource-limited settings. This document presents an overview of the World Health Organization’s procedure for the prequalification assessment of in vitro diagnostic medical devices, reflecting an updated framework that supersedes previous versions and defines the approach used to evaluate products intended for priority health conditions. It describes the scope, eligibility criteria and sequential steps required for manufacturers to apply, including pre-submission requirements, the role of performance evaluation as a prerequisite, and the distinction between full and abridged assessment pathways. The procedure examines key components such as product dossier review, inspection of manufacturing sites and labelling assessment, as well as decision-making processes leading to inclusion in the list of prequalified products. It further outlines post-qualification obligations, including reporting, surveillance and compliance requirements, and highlights the publication of assessment outcomes through standardized reports to support transparency. Intended primarily for manufacturers and stakeholders involved in procurement and regulatory processes, the document supports consistent evaluation practices to inform procurement decisions by WHO Member States and partner organizations.
Ensuring the quality, safety and performance of in vitro diagnostics is essential for reliable disease detection and informed public health decision-making, particularly in resource-limited settings. This document presents an overview of the World Health Organization’s procedure for the prequalification assessment of in vitro diagnostic medical devices, reflecting an updated framework that supersedes previous versions and defines the approach used to evaluate products intended for priority health conditions. It describes the scope, eligibility criteria and sequential steps required for manufacturers to apply, including pre-submission requirements, the role of performance evaluation as a prerequisite, and the distinction between full and abridged assessment pathways. The procedure examines key components such as product dossier review, inspection of manufacturing sites and labelling assessment, as well as decision-making processes leading to inclusion in the list of prequalified products. It further outlines post-qualification obligations, including reporting, surveillance and compliance requirements, and highlights the publication of assessment outcomes through standardized reports to support transparency. Intended primarily for manufacturers and stakeholders involved in procurement and regulatory processes, the document supports consistent evaluation practices to inform procurement decisions by WHO Member States and partner organizations.
Keywords
Diagnostic Tests, Routine, In Vitro Techniques, Reagent Kits, Diagnostic, Diagnostic Equipment, Quality Control, Quality Assurance, Health Care, Product Surveillance, Postmarketing, Evaluation Studies as Topic, International Cooperation, Accreditation, Organizational Policy, Risk Management, World Health Organization, Guideline, standards, organization and administration