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- In vitro diagnostics - Global - 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 opposed to in vivo tests, which are conducted in the body itself
- Call for experts: Strategic Advisory Group of Experts on In Vitro . . .
Issued on: 11 April 2025 New Deadline: 20 May 2025 The World Health Organization (WHO) is seeking experts to serve as members of the Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) This “Call for experts” provides information about the advisory group in question, the expert profiles being sought, the process to express interest, and the process of selection
- Specialized Technical Assistance - IVDs
For some manufacturers, meeting requirements for WHO prequalification (PQ) or emergency use listing (EUL) can be challenging In addition, global initiatives to harmonize regulation of in vitro diagnostics (IVDs) and other medical devices have resulted in changed regulatory requirements at national, regional, and global levels, which may be difficult to interpret WHO provides specialized
- Health products policy and standards - World Health Organization (WHO)
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 strategies related to in vitro diagnostics (IVDs) The SAGE IVD is expected to meet every two years to make recommendations on the content, format, and
- 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 answers provide additional clarity on the procedure and instructions documents published on our website and do not intended to introduce any new requirements or to modify any existing processes in place
- The selection and use of essential in vitro diagnostics: report of the . . .
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 diagnostics (EDL 4)) This report also includes the applications received for the EDL 4 and a summary of the deliberations and recommendations by the SAGE IVD members and the methodologist that assessed the supportive
- 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 States on the suitability for use of a specific IVD, based on a minimum set of available quality, safety, and performance data
- 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 strategies related to in vitro diagnostics (IVDs)
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