IVD HIV/Syphilis Combo Rapid Tests: progress of the active applications in the prequalification of IVDs assessment pipeline PDF Guideline/guidance
ID IVD M V VCP Impact assessment of WHO prequalification and systems supporting activities (June 2019) PDF Report
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 Guideline/guidance
IVD Instructions and requirements for Emergency Use Listing (EUL) submission: In vitro diagnostics detecting antibodies to SARS-CoV-2 virus PDF Guideline/guidance
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 Guideline/guidance
IVD Instructions for compilation of a product dossier (PQMC_018 v1, 23 January 2012) PDF Guideline/guidance
IVD Instructions for submission requirements: in vitro diagnostics (IVDs) detecting antibodies to Zika virus (PQDx_239 v4, 28 October 2016) PDF Guideline/guidance
IVD Instructions for submission requirements: in vitro diagnostics (IVDs) detecting Zika virus nucleic acid or antigen (DxPQ_240 version 3, 24 October 2016) PDF Guideline/guidance
IVD Instructions for the completion of the pre-submission form for application for prequalification of an in vitro diagnostic PDF Guideline/guidance
IVD Invitation to manufacturers of in vitro diagnostics for SARS-CoV-2 to submit an application for emergency use listing by WHO PDF Guideline/guidance
IVD Invitation to manufacturers of IVDs for mpxv NAT to submit an application for EUL PDF Information note
ID IVD IS M V VCP Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 18–21 September 2017: Agenda PDF Information note
ID IVD M V VCP Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 2–5 December 2019: Agenda PDF Information note
IVD Pre-submission form for application for prequalification of an in vitro diagnostic (PQDx_015) DOCX Application form
IVD Prequalification fees for male circumcision devices (PQMC v1, 15 April 2019) PDF Guideline/guidance
IVD Priority Categorization of Applications for Prequalification (PQ) and Emergency Use Listing (EUL) Assessments of in vitro diagnostics PDF Guideline/guidance
IVD Protocol for the evaluation of nucleic acid tests for the diagnosis of tuberculosis (TB NAT) Guideline/guidance
IVD Protocol for the performance evaluation of nucleic acid tests for the quantitative detection of hepatitis B virus DNA for WHO prequalification assessment V 1.1 Nov 2023 Guideline/guidance
IVD Protocol for the performance evaluation of rapid diagnostic tests for the detection of Vibrio cholerae O1 or O1/O139 for WHO prequalification assessment V 2.2 Nov 2023 Guideline/guidance
IVD Public announcement to TB in vitro diagnostics manufacturers, procurement agencies and national TB programmes on inclusion of WHO Prequalification for TB in vitro diagnostics PDF Advocacy material
IVD Public Report for Alinity m MPXV AMP Kit and Alinity m MPXV CTRL Kit, (MPXV 12644-027-00) PDF Report