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Prequalification Assessment

Prequalification Assessment

⚠️ Important Update – Changes to WHO’s Prequalification of IVD Assessment Procedure (from 2026)

Starting in 2026, WHO will introduce a new prequalification assessment procedure. The performance evaluation will no longer be part of the prequalification assessment and will become a separate procedure.

The information on this webpage reflects these upcoming changes. If you have any questions, please email WHO’s Prequalification of IVDs team at diagnostics@who.int.

WHO offers two types of prequalification assessments for in vitro diagnostic products: Full and Abridged

Full assessment

A full assessment includes
•    review of a product dossier
•    manufacturing site inspection
•    labelling review.

Abridged assessment

An abridged assessment may be applied: 

  • if a regulatory version of the submitted product submitted has previously been stringently assessed and approved by a recognized regulatory authority (RRA), or
  • if a regulatory version of the submitted product has not been stringently assessed and approved by an RRA, but there is another regulatory version of the product that has been stringently assessed and approved by an RRA; and in WHO’s discretion, there are no substantial differences between the two regulatory versions. 

The abridged assessment includes: 

•    review of an abridged product dossier
•    manufacturing site inspection
•    labelling review.

Refer to the guidance “WHO’s abridged prequalification assessment of in vitro diagnostics” for a detailed overview of the process.

Dossier submission and screening

Once WHO receives a dossier (full or abridged), it will

  1. Screen the dossier for completeness. Information submitted in the pre-submission form will also be considered.
  2. If the dossier is incomplete, WHO will provide two opportunities for the manufacturer to submit additional information within the set deadlines
  3. If the dossier is complete,  WHO will begin the dossier review.

Assessment components 

WHO’s prequalification assessment includes three main components (dossier review, site inspection and labelling review). Each are described in detail in “Overview of WHO’s prequalification procedure for in vitro diagnostics” (WHO document PQDx_007). Additional resources are also available:

Manufacturers should compile and submit their full or abridged product dossier following

  • PQDx_018 - Instructions for Compilation of a Product Dossier – IMDRF ToC
  • PQDx_49 Table of Contents (TOC) Product Dossier Checklist.

Refer to Technical specification series documents (where applicable) for minimum performance requirements.

See Inspection section link here to prepare for a WHO prequalification manufacturing site inspection.