All terms
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 May 5, 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.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.Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
WHO·1European Commission·1IMDRF·1
- 1
WHO Prequalification of IVDsVerifiedWHOextranet.who.int
- 2
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
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