--- title: "WHO PQ Dx Definition & Meaning | MedTech Terms" description: "WHO assessment of IVDs to support procurement by UN agencies and low- and middle-income countries. Plain-English Regulatory definition for MedTech teams, with e" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/who-pq-dx#term", "name": "WHO Prequalification (Diagnostics)", "alternateName": "WHO PQ Dx", "description": "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.", "url": "https://medtechterms.com/terms/who-pq-dx", "termCode": "who-pq-dx", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/who-pq-dx#article", "headline": "WHO PQ Dx, WHO Prequalification (Diagnostics)", "description": "WHO assessment of IVDs to support procurement by UN agencies and low- and middle-income countries.", "url": "https://medtechterms.com/terms/who-pq-dx", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/who-pq-dx" }, "about": { "@id": "https://medtechterms.com/terms/who-pq-dx#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "WHO Prequalification (Diagnostics), WHO PQ Dx, Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "WHO Prequalification of IVDs", "url": "https://extranet.who.int/prequal/vitro-diagnostics", "publisher": { "@type": "Organization", "name": "WHO" } }, { "@type": "CreativeWork", "name": "European Commission - Medical Devices", "url": "https://health.ec.europa.eu/medical-devices-sector_en", "publisher": { "@type": "Organization", "name": "European Commission" } }, { "@type": "CreativeWork", "name": "IMDRF Documents", "url": "https://www.imdrf.org/documents", "publisher": { "@type": "Organization", "name": "IMDRF" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr#term", "name": "EU In Vitro Diagnostic Regulation", "alternateName": "IVDR", "url": "https://medtechterms.com/terms/ivdr" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "WHO Prequalification (Diagnostics)", "item": "https://medtechterms.com/terms/who-pq-dx" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/who-pq-dx#faq", "mainEntity": [ { "@type": "Question", "name": "Is WHO Prequalification a mandatory regulatory requirement?", "acceptedAnswer": { "@type": "Answer", "text": "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." } }, { "@type": "Question", "name": "What types of IVDs are prioritized for WHO Prequalification?", "acceptedAnswer": { "@type": "Answer", "text": "The program prioritizes IVDs for diseases with high public health burden in low-resource settings, such as HIV, malaria, tuberculosis, hepatitis, and increasingly, emerging infectious diseases and non-communicable diseases. The specific scope is published by WHO." } }, { "@type": "Question", "name": "What is the scope of a WHO Prequalification assessment?", "acceptedAnswer": { "@type": "Answer", "text": "The assessment covers the IVD's quality, safety, and performance, including a review of manufacturing processes, quality management systems, performance validation data, and stability studies. It involves a thorough documentation review, possibly laboratory testing, and an on-site audit of the manufacturing facility." } }, { "@type": "Question", "name": "How long does the WHO Prequalification process typically take?", "acceptedAnswer": { "@type": "Answer", "text": "The duration of the prequalification process varies significantly depending on the complexity of the IVD, the completeness of the submitted dossier, and the manufacturer's responsiveness to queries. It can range from several months to over a year." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. WHO Prequalification (Diagnostics) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)WHO PQ Dx # 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 Cyber](/authors/christian-espinosa) Last 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 the regulation says The World Health Organization (WHO) Prequalification of [In Vitro Diagnostics](/terms/ivd) (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](/terms/pms-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 Is WHO Prequalification a mandatory regulatory requirement? 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. What types of IVDs are prioritized for WHO Prequalification? What is the scope of a WHO Prequalification assessment? How long does the WHO Prequalification process typically take? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Regulated Pathways](/ecosystems/regulated-pathways) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 WHO· 1 European Commission· 1 IMDRF· 1 1. [1 WHO Prequalification of IVDs Verified WHO · extranet.who.int ](https://extranet.who.int/prequal/vitro-diagnostics) 2. [2 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 3. [3 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym WHO PQ Dx Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=who-pq-dx) Learn in 60 seconds Card Lesson Quiz WHO assessment of IVDs to support procurement by UN agencies and low- and middle-income countries. - · WHO PQ status is a de facto requirement for Global Fund and Gavi procurement and increasingly referenced by national regulators in low-resource settings. Remember this Watch out: 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. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) You may also need Auto-suggested from Regulatory and shared keywords. - [EU Reference Laboratory (EURL)(EURL) ](/terms/ivdr-eu-reference-laboratory) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [Pre-Approval Inspection(PAI) ](/terms/pai) - [Risk-Based Monitoring(RBM) ](/terms/risk-based-monitoring) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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