IVD Protocol for evaluation of Nucleic acid tests for detection of drug resistance in Mycobacterium tuberculosis complex Guideline/guidance
IVD 1st Invitation to laboratories to submit an expression of interest (23 May 2016) PDF Guideline/guidance
IVD 1st Invitation to manufacturers of IVDs medical devices used for the qualitative detection of Mycobacterium tuberculosis complex DNA and mutations associated with drug-resistant tuberculosis to apply for WHO prequalification assessment as of 22 September PDF
ID IVD IS M V VCP 2023 Joint UNICEF-UNFPA-WHO Meeting - Aligning WHO Normative and Prequalification Processes PDF Presentation
ID IVD IS M V VCP 2023 Joint UNICEF-UNFPA-WHO Meeting - Update and progress on the Coordinated Scientific Advice (CSA) PDF Presentation
IVD A risk-based approach for the assessment of in vitro diagnostics (IVDs) (PQDx_152 v1, 13 May 2014) PDF Guideline/guidance
IVD Abridged prequalification assessment: prequalification of in vitro diagnostics (PQDx_173_v5_8 Nov 2023) Guideline/guidance
IVD Application form for prequalification of a male circumcision device (PQMC_015 v1, 13 September 2011) DOC Application form
IVD CD4 Technologies: progress of the active applications in the prequalification of IVDs assessment pipeline PDF Guideline/guidance
IVD Change reporting form for a WHO-prequalified male circumcision device (PQMC_119 v1, April 2019) DOCX
IVD Change request form for a reportable changes to WHO PQ and EUL IVDs (PQDx_119 March 2025) DOCX Application form
IVD Consultation on the documentary evidence and independent performance evaluation requirements for the Emergency Use Assessment and Listing procedure for Zika virus in vitro diagnostics, March 2016 PDF Report
IVD Emergency Use Assessment and Listing Procedure (EUAL) for candidate in vitro diagnostics (IVDs) for use in the context of a public health emergency (7 July 2015) PDF Guideline/guidance
IVD Expression of interest submission form for prequalification evaluating laboratories (IVD/TP/12a v3.1) DOCX Application form
IVD FAQ: EUL assessment of IVD to detect SARS-CoV-2 or anti-SARS-CoV-2 antibodies PDF Guideline/guidance
IVD FAQ: WHO Global TB programme class recommendations and WHO Prequalification (PQ) product assessments PDF Advocacy material
IVD Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics (2020) Guideline/guidance
IVD M HIV market report: the state of HIV treatment, testing and preventing in low- and middle-income countries (CHAI, September 2020) PDF Report