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WHO Prequalification (Diagnostics)
WHO assessment of IVDs to support procurement by UN agencies and low- and middle-income countries.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026
Definition
The WHO Prequalification programme evaluates the quality, safety, and performance of priority IVDs (e.g., HIV, malaria, TB, hepatitis) through dossier review, performance evaluation, and manufacturing site inspection. WHO Prequalification of in vitro diagnostics assesses product dossiers, inspects manufacturing sites and evaluates performance for priority diseases such as HIV, malaria, hepatitis and tuberculosis. Prequalified products appear on a public list used by UN agencies and many national procurement programs in low and middle income countries. An abridged assessment pathway exists for products already approved by stringent regulators. What the regulation says
The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) programme assesses IVDs intended for high-burden diseases in resource-limited settings. This assessment ensures these IVDs meet international standards for quality, safety, and performance, facilitating their procurement and use by international agencies and national programs. The program involves a comprehensive evaluation process that includes dossier review, performance verification, manufacturing site inspections, and a post-market surveillance plan, as detailed in various WHO technical guidance documents for IVD prequalification.What this means in practice
WHO PQ status is a de facto requirement for Global Fund and Gavi procurement and increasingly referenced by national regulators in low-resource settings.Examples
- A diagnostic kit for HIV receives WHO Prequalification, making it eligible for purchase by organizations like UNICEF for distribution in African countries.
- A malaria rapid diagnostic test (RDT) with WHO Prequalification is adopted by a national malaria control program in Southeast Asia as part of its diagnostic strategy.
- A manufacturer of a tuberculosis diagnostic submits its product for WHO Prequalification to increase its market access in countries supported by the Global Fund.
Common pitfalls
- •A common pitfall is misunderstanding that WHO Prequalification is a regulatory approval in itself, rather than an assessment program that informs procurement and national registration processes.
- •Manufacturers sometimes underestimate the rigor of the dossier requirements and the on-site audit process, leading to delays or failure in prequalification.
- •Assuming that a device prequalified for one intended use is automatically suitable for all uses, without considering specific labeling and performance claims, is a mistake.
- •Failing to maintain the quality management system and post-market surveillance commitments after prequalification can lead to suspension or withdrawal of PQ status.
- •Another pitfall is not engaging with WHO guidance documents early in the product development process, which can result in significant rework to meet prequalification requirements.
Frequently asked questions
While not a mandatory regulatory approval in the same vein as FDA clearance or EU CE marking, WHO Prequalification is often a de facto requirement for procurement by major international bodies like the Global Fund and Gavi, and it influences national regulatory decisions in many countries.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 2Regulator guidance and consensus· 3
Link health: 3 verified· last checked 2026-06-20
WHO·1European Commission·1IMDRF·1
- 1WHO Prequalification of IVDsTier 2 VerifiedWHOextranet.who.int
- 2European Commission - Medical DevicesTier 2 VerifiedEuropean Commissionhealth.ec.europa.eu
- 3IMDRF DocumentsTier 2 VerifiedIMDRFimdrf.org
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