IVD Technical Specifications Series (TSS) 19 - In-vitro diagnostic medical devices for monitoring of blood glucose in capillary blood Guideline/guidance
IVD Technical Specifications Series (TSS) 20 - In vitro diagnostic medical devices used for the qualitative detection of SARS-CoV-2 nucleic acid Guideline/guidance
IVD Technical Specifications Series (TSS) 21 - SARS-CoV-2 antigen rapid diagnostic tests for professional use and self-testing Guideline/guidance
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 Guideline/guidance
IVD Technical Specifications Series (TSS) 25 - Rapid diagnotic tests to detect Neisseria gonorrhoeae antigen PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 26 - Rapid diagnostic tests to detect Chlamydia trachomatis antigen PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 27 - Syphilis Rapid Diagnostic Tests for Professional Use and/or Self-testing PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 9 - Immunoassays to detect HIV antibody and/or antigen PDF Guideline/guidance
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 Guideline/guidance
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 Guideline/guidance
V Terms of Reference for the Technical Advisory Group on Snake Antivenom Immunoglobulin Listing (TAG-SAIL) PDF Guideline/guidance
IVD The Assessment Process for Listing of WHO Prequalification Evaluating Laboratories for IVDs PDF Guideline/guidance
IVD The assessment process for listing of WHO prequalification evaluating laboratories for IVDs (PQDx_248 v1.0, 23 May 2016) PDF Guideline/guidance
M Three more Nigerian companies meet international pharmaceutical manufacturing standards PDF Guideline/guidance
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 Guideline/guidance
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 Guideline/guidance
IVD TSS 24 - In Vitro diagnostic medical devices used for the qualitative detection of Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis nucleic acid Guideline/guidance
M Use of ICHQ3D guideline in the assessment of APIMFs submitted in support of an FPP or prequalified API (18 October 2019) PDF Guideline/guidance
VCP Use of third-party agents for communication and interaction with WHO PQT/VCP PDF Guideline/guidance
M Variation to a prequalified finished pharmaceutical product (FPP): major, minor or immediate notification (5 December 2015) DOCX Application form
VCP Vector Control Products: Converting from WHOPES Recommendation to Prequalification Listing PDF Guideline/guidance
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: FilmArray Biothreat-E EUAL number: EAE 0433-154-00 PDF Report
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: FilmArray Biothreat-E EUAL number: EAE 0433-154-00 PDF Report
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: Liferiver™ ‒ Ebola Virus (EBOV) Real Time RT-PCR kit number: EAE 0432-139-00 PDF Report
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: Liferiver™ ‒ Ebola Virus (EBOV) Real Time RT-PCR Kit number: EAE 0432-139-00 PDF Report
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: STANDARD™ Q Ebola Zaire Ag EUAL number: EAE 0444-117-00 PDF Report
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: STANDARD™ Q Ebola Zaire Ag EUAL number: EAE 0444-117-00 PDF Report
IVD WHO EUAL Delisting: Product: ReEBOVTM Antigen Rapid Test Kit EUAL number: EA 0011-011-00 PDF Information note
IVD WHO EUAL Public Report for Ebola IVD: Product: OraQuick® Ebola Rapid Antigen Test Kit (cadaveric oral fluid and whole blood) EUAL number: EA 0023-021-00 PDF Report
IVD WHO EUAL Public Report for Ebola IVD: Product: RealStar® Filovirus Screen RT-PCR Kit 1.0 Application number: EAE 0425-153-00 PDF Report
IVD WHO EUAL Public Report for Ebola IVD: Product: Xpert Ebola Assay EUAL number: EAE 0443-070-00 PDF Report
IVD WHO EUAL Public Report for Ebola IVD: Product: Xpert Ebola Assay EUAL number: EAE 0443-070-00 PDF Report