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