IVD Protocol for evaluation of Nucleic acid tests for detection of drug resistance in Mycobacterium tuberculosis complex
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
ID IVD IS M V VCP 2023 Joint UNICEF-UNFPA-WHO Meeting - Update and progress on the Coordinated Scientific Advice (CSA) PDF
IVD A risk-based approach for the assessment of in vitro diagnostics (IVDs) (PQDx_152 v1, 13 May 2014) PDF
IVD Abridged prequalification assessment: prequalification of in vitro diagnostics (PQDx_173_v5_8 Nov 2023)
IVD Application form for prequalification of a male circumcision device (PQMC_015 v1, 13 September 2011) DOC
IVD CD4 Technologies: progress of the active applications in the prequalification of IVDs assessment pipeline PDF
IVD Change report form for a WHO-prequalified in vitro diagnostic (PQDx_119 v2, 2 December 2016) DOCX
IVD Change reporting form for a WHO-prequalified male circumcision device (PQMC_119 v1, April 2019) DOCX
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
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
IVD Expression of interest submission form for prequalification evaluating laboratories (PQDx_250 v2.0 - 14 April 2022) DOCX
IVD FAQ: WHO Global TB programme class recommendations and WHO Prequalification (PQ) product assessments PDF
IVD Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics (2020)
IVD M HIV market report: the state of HIV treatment, testing and preventing in low- and middle-income countries (CHAI, September 2020) PDF
IVD HIV/Syphilis Combo Rapid Tests: progress of the active applications in the prequalification of IVDs assessment pipeline PDF
ID IVD M V VCP Impact assessment of WHO prequalification and systems supporting activities (June 2019) PDF
IVD Information for manufacturers on the inspection of manufacturing sites: Prequalification of male circumcision devices (PQDx_014 V4, Version MC_0, 15 November 2012) PDF
IVD Instructions and requirements for Emergency Use Listing (EUL) submission: In vitro diagnostics detecting antibodies to SARS-CoV-2 virus PDF
IVD Instructions and requirements for Emergency Use Listing (EUL) submission: In vitro diagnostics detecting SARS-CoV-2nucleic acidandrapid diagnostics tests detecting SARS-CoV-2 antigens PDF