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 …
In vitro diagnostics: Frequently asked questions
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 and …
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 …
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 releases new list of essential diagnostics; new …
Oct 19, 2023 · Updated biennially, the Essential Diagnostics List is intended to support national in vitro diagnostics policy development and to improve access to IVD testing and clinical …
Regulation and Prequalification - World Health Organization (WHO)
It is intended to assist interested procurement agencies and Member States on the suitability for use of a specific IVD, based on a minimum set of available quality, safety, and performance …
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 …
Regulation and Prequalification - World Health Organization (WHO)
A field safety notice (FSN) is an important means of communicating a field safety corrective action (FSCA) and related safety information to users. It may also provide updated information about …
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 …
Invitation to Manufacturers of diagnostic products for diagnosis of ...
May 23, 2024 · WHO supports the procurement of diagnostic products and related laboratory items for the diagnosis and management of many communicable and non-communicable …