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On this page readers can obtain a listing of documents under the subject headings. Click on the name of a subject heading to display the sub-headings, or to return to the main subjects. Click on the icon of a sub-heading to obtain the concerned documents. Publications are available in HTML, PDF , DOC or XLS format. Click on the corresponding icon to open the publication. The PDF icon located on the cover page of a publication represents that the publication is available only in PDF format. If the PDF icon is located near the title of the publication it means the document is available in both HTML and PDF formats.
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46 documents on 1 page
 
 
 
 
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Emergency Use Assessment and Listing Procedure (EUAL) for Candidate in Vitro Diagnostics (IVDs) for Use in the Context of a Public Health Emergency

Year:

2015;

Pages:

11;


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First WHO Model List of Essential In Vitro Diagnostics. Geneva: World Health Organization; 2019 (WHO Technical Report Series, No. 1017)

Year:

2019;

Pages:

29;


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Guidance for Procurement of in Vitro Diagnostics and Related Laboratory Items and Equipment. Geneva: World Health Organization; 2017 [French]

Year:

2018;

Pages:

48;


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A Guide to Aid the Selection of Diagnostic Tests. (Bull World Health Organ 2017;95:639–645)

Year:

2017;

Pages:

7;


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Harmonization of Rapid Diagnostic Tests for Malaria and Implications for Procurement. 26–27 February 2015 Geneva, Switzerland. Meeting Report

Year:

2015;

Pages:

45;


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Information for Manufacturers on the Inspection of Manufacturing Site(s). (Assessment of the Quality Management System) - WHO Prequalification of In Vitro Diagnostics

Year:

2017;

Pages:

32;


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Instructions for compilation of a product dossier - Prequalification of In Vitro Diagnostics Programme

Year:

2014;

Pages:

37;


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Instructions for the completion of the pre-submission form - Prequalification of In Vitro Diagnostics

Year:

2017;

Pages:

10;


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Landscape of Diagnostics Against Antibacterial Resistance, Gaps and Priorities. Geneva: World Health Organization; 2019

Year:

2019;

Pages:

128;


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Lignes directrices pour la surveillance post commercialisation des dispositifs médicaux de diagnostic in vitro (DIV) . Genève : Organisation mondiale de la Santé ; 2017 [English] [Russian]

Year:

2017;

Pages:

64;


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Lignes directrices pour l’achat de dispositifs médicaux de diagnostic in vitro et articles et équipements de laboratoire connexes . Genève : Organisation mondiale de la Santé ; 2017 [English]

Year:

2018;

Pages:

48;


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Malaria Rapid Diagnostic Test Performance: Results of Who Product Testing of Malaria Rdts: Round 7 (2015-2016). Geneva: World Health Organization; 2017

Year:

2017;

Pages:

164;


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Malaria Rapid Diagnostic Test Products: Suggested Use of Terms, Requirements and Preferences for Labelling and Instructions for Use. Geneva: World Health Organization; 2017

Year:

2017;

Pages:

39;


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Meeting Report for Technical Consultation on In Vitro Diagnostics for AMR, 27–28 March 2019. Geneva: World Health Organization; 2019

Year:

2019;

Pages:

11;


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Molecular Methods for Antimicrobial Resistance (AMR) Diagnostics to Enhance the Global Antimicrobial Resistance Surveillance System (GLASS). Geneva: World Health Organization; 2019

Year:

2019;

Pages:

64;


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Overview of the WHO Prequalification of in Vitro Diagnostics Assessment. Version 8. Geneva: World Health Organization; 2018 - WHO Prequalification of in Vitro Diagnostics

Year:

2018;

Pages:

28;


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Post-market Surveillance of in Vitro Diagnostics [French] [Russian]

Year:

2015;

Pages:

63;


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Product dossier checklist - Prequalification of In Vitro Diagnostics Programme

Year:

2014;

Pages:

13;


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Second WHO Model List of Essential In Vitro Diagnostics. Geneva: World Health Organization; 2019

Year:

2019;

Pages:

50;


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Selection and Use of Ebola in Vitro Diagnostic (Ivd) Assays. Emergency Guidance. June 2015

Year:

2015;

Pages:

9;


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The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2019 (including the second WHO model list of essential in vitro diagnostics). Geneva: World Health Organization; 2019. (WHO Technical Report Series, No. 1022)

Year:

2019;

Pages:

236;


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Technical Guidance Series 6 (TGS-6) for WHO Prequalification – Diagnostic Assessment: Panels for Quality Assurance and Quality Control of in Vitro Diagnostic Medical Devices

Year:

2017;

Pages:

57;


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Technical Guidance Series 7 (TGS-7) for WHO Prequalification - Diagnostic Assessment: Risk Management for Manufacturers of in Vitro Diagnostic Medical Devices

Year:

2018;

Pages:

66;


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Technical Guidance Series 8 (TGS-8) for WHO Prequalification – Diagnostic Assessment: Quality Control for In Vitro Diagnostic Medical Devices for WHO Prequalification. (Draft for Comment 9 April 2019)

Year:

2019;

Pages:

40;


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World Health Organization Model List of Essential In Vitro Diagnostics. First edition (2018). Report of the first Strategic Advisory Group on In Vitro Diagnostics (SAGE-IVD). WHO headquarters, Geneva, 16–20 April 2018. Executive summary

Year:

2018;

Pages:

35;


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Пострегистрационный надзор за медицинскими изделиями для диагностики in vitro . Женева: Всемирная организация здравоохранения; 2018 [English] [French]

Year:

2018;

Pages:

64;


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