In vitro diagnostics - Global
Sep 28, 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 tubes and similar …
WHO Information Notice for IVD Users 2026/01
Mar 16, 2026 · As part of the WHO pre- and post-prequalification product review process, WHO’s Prequalification Unit conducted a special (for-cause) inspection of the quality management system …
In vitro diagnostics - World Health Organization (WHO)
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 tubes and similar equipment, as …
Call for experts: Strategic Advisory Group of Experts on In Vitro ...
Apr 11, 2025 · SAGE IVD members are appointed for 2 years and can be reappointed once. Functions of the Strategic Advisory Group of Experts on In Vitro DiagnosticsTo serve as a principal advisory …
Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD)
In 2018, the World Health Organization (WHO) established the Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) to act as an advisory body to matters of global policies and …
In vitro diagnostics: Frequently asked questions
Aug 29, 2022 · 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 antibodies. These questions …
Health products policy and standards
Jan 28, 2021 · 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 …
First WHO model list of essential in vitro diagnostics
Mar 29, 2019 · WHO technical report series; 1017. The EDL will provide guidance and serve as a reference to ministries of health, programme managers, users such as laboratory managers, …
WHO releases new list of essential diagnostics; new recommendations …
Oct 19, 2023 · The World Health Organization (WHO) has released its 2023 Essential Diagnostics List (EDL), which is an evidence-based register of in vitro diagnostics (IVD) that supports countries to …
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 regulation …