In vitro diagnostics - Global - World Health Organization (WHO)
Feb 10, 2020 · In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means ‘in glass’, meaning these tests are typically conducted in test …
Specialized Technical Assistance - IVDs
Feb 14, 2023 · For some manufacturers, meeting requirements for WHO prequalification (PQ) or emergency use listing (EUL) can be challenging. In addition, global initiatives to harmonize …
WHO Information Notice for IVD Users 2021/01
Jan 18, 2021 · IVD users should routinely review test results to detect unexpected increases or decreases in test results, including positivity rate, target detection rate, invalid or unreturnable …
In vitro diagnostics: Frequently asked questions
Aug 6, 2019 · This page provides answers to frequently asked questions relating to EUL assessment of in vitro diagnostics (IVD) to detect SARS-CoV-2 or anti-SARS-CoV-2 …
Regulation and Prequalification - World Health Organization (WHO)
The EUL procedure is developed to expedite the availability of IVDs needed in public health emergency situations. It is intended to assist interested procurement agencies and Member …
PQT_IVD_Q&A_200806version1 Page 1 of 3. PQT-IVD Questions and Answers document 06 August 2020 version 1 . This page provides answers to frequently asked questions relating to …
WHO Announces Second Week of Quality Training: Registrations …
Jun 13, 2024 · The Week of Quality for IVDs 2024 with the theme Optimising IVD product development: principles of design, quality and compliance is specifically designed to equip …
The selection and use of essential in vitro diagnostics: report of the ...
Oct 18, 2023 · Technical report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model list of essential in vitro …
4th Meeting of the Strategic Advisory Group of Experts on IVDs
Nov 18, 2022 · The 4th SAGE IVD meeting was held on 14–18 November 2022 in a virtual format. On the first day of the meeting, the WHO EDL Secretariat organized an open webinar session …
Health products policy and standards - World Health Organization …
The World Health Organization (WHO) has established a Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) to act as an advisory body on matters of global policies and …