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37 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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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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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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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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Overview of the WHO Prequalification of in Vitro Diagnostics Assessment - Prequalification of in Vitro Diagnostics

Year:

2017;

Pages:

28;


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

Year:

2015;

Pages:

9;


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Technical Guidance Series 1 (TGS–1) for WHO Prequalification of in Vitro Diagnostic Medical Devices: Standards Applicable to the Who Prequalification of in Vitro Diagnostic Medical Devices

Year:

2017;

Pages:

33;


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Technical Guidance Series 4 (TGS–4) for WHO Prequalification – Diagnostic Assessment: Guidance on Test Method Validation for in Vitro Diagnostic Medical Devices

Year:

2017;

Pages:

26;


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Technical Guidance Series 5 (TGS–5) for WHO Prequalification – Diagnostic Assessment: Designing Instructions for Use for in Vitro Diagnostic Medical Devices

Year:

2017;

Pages:

37;


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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 6 (TGS-6) for WHO Prequalification – 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 Specifications Series 2 (Tss–2) for Submission to Who Prequalification – Diagnostic Assessment: In Vitro Diagnostic Medical Devices to Identify Glucose-6-phosphate Dehydrogenase (G6pd) Activity

Year:

2016;

Pages:

22;


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Technical Specifications Series 3 (Tss–3) for Submission to Who Prequalification – Diagnostic Assessment: Malaria Rapid Diagnostic Tests

Year:

2017;

Pages:

23;


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Technical Specifications Series 4 (Tss–4) for Submission to Who Prequalification – Diagnostic Assessment: In Vitro Diagnostic Medical Devices (Ivds) Used for the Detection of High-risk Human Papillomavirus (Hpv) Genotypes in Cervical Cancer Screening

Year:

2018;

Pages:

29;


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Technical Specifications Series 5 (Tss–5) for Submission to Who Prequalification – Diagnostic Assessment: Rapid Diagnostic Tests (Rdts) Used for Surveillance and Detection of an Outbreak of Cholera

Year:

2018;

Pages:

25;


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WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices. (WHO Medical Device Technical Series)

Year:

2017;

Pages:

76;


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WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices. WHO Technical Report Series, No. 1003, 2017, Annex 4

Year:

2017;

Pages:

76;


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World Health Organization Model List of Essential In Vitro Diagnostics. First edition (2018). 16 May 2018

Year:

2018;

Pages:

29;


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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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