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 …
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 …
Week of Quality for In Vitro Diagnostics 2025: Registration Now …
Jun 5, 2025 · Join us for the WHO's Week of Quality for IVDs training program. Register your interest to participate in this valuable training program. IVD manufacturers and regulatory …
Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE …
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 …
WHO approves first mpox diagnostic test for emergency use, …
Oct 3, 2024 · The World Health Organization (WHO) has listed the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure, an important step in improving global …
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 …
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 …
In vitro diagnostics for COVID-19 - World Health Organization …
Jun 14, 2021 · 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 …
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 Users 2020/05
Jan 13, 2021 · This notice supersedes WHO Information Notice for In Vitro Diagnostic Medical Device (IVD) Users 2020/05 version 1, issued 14 December 2020. Description of the problem: …