IVD Technical Guidance Series (TGS) 1 - Standards applicable to the WHO Prequalification of in vitro diagnostic medical devices PDF
IVD Technical Guidance Series (TGS) 2 - Establishing stability of in vitro diagnostic medical devices PDF
IVD Technical Guidance Series (TGS) 4 - Test method validation for in vitro diagnostic medical devices
IVD Technical Guidance Series (TGS) 5 - Designing instructions for use for in vitro diagnostic medical devices PDF
IVD Technical Specifications Series (TSS) 10 - In vitro diagnostic medical devices used for the qualitative and quantitative detection of Hepatitis C RNA
IVD Technical Specifications Series (TSS) 11 - In vitro diagnostic medical devices used for the quantitative detection of HIV-1 nucleic acid
IVD Technical Specifications Series (TSS) 13 - Rapid diagnostic tests to detect hepatitis B surface antigen
IVD Technical Specifications Series (TSS) 14 - Immunoassays to detect hepatitis B virus surface antigen
IVD Technical Specifications Series (TSS) 15 - In vitro diagnostic medical devices used for the quantitative detection of Hepatitis B DNA
IVD Technical Specifications Series (TSS) 16 - Hepatitis C rapid diagnostic tests for professional use and/or self-testing, 2021 update
IVD Technical Specifications Series (TSS) 18 - Haemoglobin A1c point of care analysers for professional use PDF
IVD Technical Specifications Series (TSS) 19 - In-vitro diagnostic medical devices for monitoring of blood glucose in capillary blood
IVD Technical Specifications Series (TSS) 20 - In vitro diagnostic medical devices used for the qualitative detection of SARS-CoV-2 nucleic acid
IVD Technical Specifications Series (TSS) 21 - SARS-CoV-2 antigen rapid diagnostic tests for professional use and self-testing
IVD Technical Specifications Series (TSS) 24 - In Vitro diagnostic medical devices used for the qualitative detection of Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis nucleic acid PDF
IVD Technical Specifications Series (TSS) 25 - Rapid diagnotic tests to detect Neisseria gonorrhoeae antigen PDF
IVD Technical Specifications Series (TSS) 26 - Rapid diagnostic tests to detect Chlamydia trachomatis antigen PDF
IVD Technical Specifications Series (TSS) 27 - Syphilis Rapid Diagnostic Tests for Professional Use and/or Self-testing PDF
IVD Template for public comments to draft TSS 22 – Haemoglobin point of care analysers. Submit comments to diagnostics@who.int by 17 June 2024 XLSX
IVD Template for public comments to draft TSS 3 – Malaria rapid diagnostic tests second edition. Submit comments to diagnostics@who.int by 17 June 2024 XLSX
V Terms of Reference for the Technical Advisory Group on Snake Antivenom Immunoglobulin Listing (TAG-SAIL) PDF
IVD The assessment process for listing of WHO prequalification evaluating laboratories for IVDs (PQDx_248 v1.0, 23 May 2016) PDF
IVD Transitioning Emergency Use Listing for in vitro diagnostics to prequalification assessment - Questions and Answers PDF
IVD TSS 23– Rapid diagnostic tests to detect mycobacterial lipoarabinomannan (LAM) antigen in urine, draft for comment. Comments to be submitted by 17 June 2024 PDF
IVD TSS 3 - Malaria rapid diagnostic tests second edition, draft for comment. Comments to be submitted by 17 June 2024 PDF