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