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What We Do

What We Do

We prequalify in vitro diagnostics

The  aim  of  WHO  prequalification  of  in vitro diagnostics (IVDs) is  to  promote  and facilitate access to safe, appropriate and affordable in vitro diagnostics of good quality in an equitable  manner. The focus is on IVDs for priority diseases  that are appropriate for use in resource-limited settings.

WHO IVD prequalification incorporates comprehensive assessment of individual IVDs through a standardized procedure, to determine whether the product meets WHO prequalification requirements. Assessment has three components:

  • review of a product dossier
  • laboratory evaluation of performance and operational characteristics
  • manufacturing site(s) inspection

Following prequalification post-market surveillance is undertaken. It includes reactive and proactive measures, through complaint reporting and post-shipment/pre-distribution lot testing. Post-qualification also includes mandatory manufacturer notification of changes to the product or the quality management system.

The WHO Prequalification Unit performs assessments of in vitro diagnostics (IVDs) to verify compliance with quality, safety and performance requirements. Three distinct assessments can be undertaken, depending on a number of aspects outlined below.

Table 1 summarizes the main differences among the three assessment mechanisms: (1) Prequalification – PQ, (2) Expert review panel – ERPD and (3) the Emergency Use Listing procedure – EUL.

Table 1: Comparative assessments table

Scope/eligibility Defined PQ eligibility criteria
  • Defined in each ERPD EOI
Defined in the EUL EOI (PHEIC-driven)           
Responsible for EOI/eligibility WHO Prequalification Unit based on an agreement with the respective WHO technical programme
  • Global Fund/UNITAID or
  • Procurement agency or
  • WHO technical programme
WHO Prequalification Unit in agreement with WHO/WHE
Timing Open call for applications within eligibility criteria Defined in each ERPD EOI Defined in the EUL EOI (PHEIC-driven)
Responsibility for receiving applications WHO Prequalification Unit
  • Global Fund/UNITAID or
  • Procurement agency or
  • WHO technical programme
WHO Prequalification Unit
Assessment fees PQ fees payable No fees payable No fees payable
Responsible for the technical review WHO Prequalification Unit WHO Prequalification Unit WHO Prequalification Unit
Assessment components
  • Product dossier
  • Site inspection
  • Performance evaluation
  • Labelling review
  • Completed ERPD questionnaire
  • Documented evidence
  • EUL documented evidence defined in the EUL EOI
Requirements Defined in PQ documents, including PQ Technical Specifications (TSS) Risk-based approach Essential data requirements outlined in the EUL instruction document
Outcome Products that meet requirements added to WHO Prequalification List A Risk Category for procurement will be assigned Products that meet requirements added to WHO Emergency Use List
Publication of assessment outcomes For PQ-listed products only
  • List of prequalified IVDs
Managed by the agency/programme responsible for EOI/eligibility For listed products and products which failed EUL listing
  • List of EUL-ed IVDs


Dossier review

Transition to the International Medical Device Regulators Forum (IMDRF) Table of Contents (ToC) format for product dossier submissions

Manufacturers should compile and submit the product dossier as prescribed in PQDx_018 v5 - Instructions for Compilation of a Product Dossier – IMDRF ToC and Table of Contents (TOC) Product Dossier Checklist. Please direct any enquiries to

WHO reviews the product dossier to:

  • assessing evidence in support of safety and performance of the product
  • determining whether the manufacturer's quality management system is of an adequate standard to warrant an inspection of the manufacturing site
  • assessing product design and manufacture.

If the dossier is incomplete, the manufacturer will be requested to submit additional information within a specified time period. Once a dossier has been accepted, assessment can proceed to the laboratory evaluation and manufacturing site inspection.

We prequalify male circumcision devices

WHO staff responsible for prequalification of IVDs also undertake prequalification of male circumcision devices.

The approach and standards applied to prequalification of  MCDs are very similar to those applied for IVD prequalification.

Our key outputs

The key outputs for WHO immunization devices prequalification are: