Prequalification Guidance
Prequalification guidance documents relating to in vitro diagnostics (IVDs) represent WHO's current thinking with respect to:
- IVDs eligible for WHO prequalification assessment
- the intended use settings where the WHO prequalified-IVDs will be used
- the intended users of WHO-prequalified IVDs.
The guidance documents are issued in support of WHO's objective to improve access to safe, effective and quality IVDs. They are intended to help assist IVD manufacturers understand the requirements for WHO prequalification assessment and/or procurement by WHO and other UN agencies. They should be consulted together with relevant Technical Specifications Series and Technical Guidance Series documents.
How to provide input for guidance development
Guidance documents are published in draft on the WHO prequalification website for a specified public comment period. For most documents, the comment period is two months. However, the length of time may vary, depending on the document. Public comment tables are made available for each document.
Comments should be submitted to: diagnostics@who.int.
Prequalification guidance documents, application forms & templates by topic
(Document number, version and date of issue are given in brackets.)
For in vitro diagnostic prequalification
Prequalification requirements
Eligibility criteria for WHO’s prequalification assessment of in vitro diagnostics (PQDx_298)
Overview of WHO’s prequalification procedure for in vitro diagnostics (PQDx_007)
WHO’s Prequalification assessment fees (PQDx_299)
WHO’s abridged prequalification assessment for in vitro diagnostics (PQDx_173)
Instructions for completion of the pre-submission form (PQDx_017)
Instruction for compilation of a product dosser (PQDx_18 - IMDRF ToC)
POSITION NOTE: Medical device accessories supplied with WHO prequalified/EUL-listed IVDs
Post-prequalification requirements
WHO’s Prequalification assessment fees (PQDx_299)
Reportable changes to a WHO PQ and EUL IVDs (PQDx_121 March 2025)
Application & submission forms & templates
Pre-submission form (PQDx_015)
Product dossier checklist (PQDx_049)
Reportable change report form to a WHO PQ and EUL IVDs (PQDx_119 March 2025)