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

A risk-based approach for the assessment of in vitro diagnostics (IVDs) (PQDx_152 v1, 13 May 2014)

Risk-based classification of diagnostics for WHO prequalification) (PQDx_172 v1, 13 May 2014)

Eligibility criteria for WHO prequalification of in vitro diagnostics (PQDx_298 v4, 25 March 2019)

Overview of WHO prequalification of in vitro diagnostics assessment (version 9, 04 January 2021)

Descripción general de la Precalificación de Diagnósticos in vitro de la OMS

Prequalification assessment and change assessment target deadlines (PQDx_300 v1, 21 July 2017)

Abridged prequalification assessment (PQDx_173,  04 January 2021)

Instructions for the completion of the pre-submission form for application for prequalification of an in vitro diagnostic (PQDx_017 v5, 21 July 2017)

Draft: Instructions for compilation of a product dossier ‒ IMDRF ToC (PQDx_018, 21 March 2020)

Information for manufacturers on the inspection of manufacturing sites (Assessment of the quality management system) (PQDx_014 V4, 08 September 2017)

Prequalification fees: WHO prequalification of in vitro diagnostics (PQDx_299 v2, 01 August 2018)


Performance evaluation

Form to submit expression of interest in becoming a prequalification evaluating laboratory (PQDx_250 v1.0, 23 May 2016)

Protocol for performance laboratory evaluation of glucose-6-phosphate dehydrogenase deficiency point-of-care tests (PQDx_267 v1.0)

Protocol for performance laboratory evaluation of HBsAG serology assays (PQDx_108 v8, December 2017)

Protocol for performance laboratory evaluation of hepatitis C serology assays (PQDx_040 v6, February 2017)

Protocol for performance laboratory evaluation of hepatitis C virus molecular assays (PQDx_225 v4.0, 2018)

Protocol for performance laboratory evaluation of combined HIV/syphilis serology assays (PQDx_150 v4.1)

Protocol for performance laboratory evaluation of  HIV oral fluid serology assays (PQDx_154 v3.1)

Protocol for performance laboratory evaluation of HIV self-testing serology assays (capillary blood) (PQDx_241 v4.0, 1 November 2017)

Protocol for performance laboratory evaluation of HIV serology assays (PQDx_030 v10.1, December 2017)

Protocol for performance laboratory evaluation of lymphocyte subsets enumeration technologies (PQDx_030 v5, June 2017)

Protocol for performance laboratory evaluation of malaria rapid diagnostic tests (PQDx_317 v1.0)

Protocol for performance laboratory evaluation of nucleic acid-based HIV viral load-testing laboratories (PQDx_215, 2017)

Protocol for performance laboratory evaluation of qualitative HIV molecular assays (PQDx_199 v2.0)

Protocol for performance laboratory evaluation of rapid diagnostic tests for detection of Vibrio cholerae LPS antigen (PQDx_305 v1.0)

Protocol for performance laboratory evaluation of Treponemal and non-Treponemal serology rapid diagnostic tests (PQDx_326 v1.0)


Post-prequalification requirements

Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics (2020)  

Prequalification assessment and change assessment target deadlines (PQDx_300 v1, 21 July 2017)

Prequalification fees: WHO prequalification of in vitro diagnostics (PQDx_299 v2, 1 August 2018)

Reportable changes to a WHO prequalified in vitro diagnostic (PQDx_121 v2, December 2016)


Application & submission forms & templates

Pre-submission form for application for prequalification of an in vitro diagnostic (PQDx_015 v6), 21 July 2017)

Product dossier checklist (PQDx_049 v2 30 June 2014)

Change report form for a WHO-prequalified in vitro diagnostic (PQDx_119 v2, 2 December 2016)

Form to submit expression of interest in becoming a prequalification evaluating laboratory (PQDx_250 v1.0, 23 May 2016)


For male circumcision device prequalification

Prequalification requirements

Overview of the WHO prequalification of male circumcision devices assessment (PQMC_007 v2, 15 April 2019)

Instructions for the completion of the application form (PQMC_017 v1, 13 September 2011)

Instructions for compilation of a product dossier (PQMC_018 v1, 23 January 2012)

Product dossier checklist (PQMC_049 v1, 6 January 2012)

Information for manufacturers on the inspection of manufacturing sites: Prequalification of male circumcision devices (PQDx_014 V4, Version MC_0, 15 November 2012)

Prequalification fees for male circumcision devices (PQMC v1, 15 April 2019)


Post-prequalification requirements

Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics (2020)

Reportable changes to a WHO-prequalified male circumcision device (PQMC_121 v1, April 2019)

Application & submission forms & templates 

Application for prequalification of a male circumcision device (PQMC_015 v1, 13 September 2011)

Change reporting form for a WHO-prequalified male circumcision device (PQMC_119 v1, April 2019)