2020年2月10日 · 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.

2023年2月14日 · 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 …

2021年1月18日 · 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 result rate, etc. These variations may be early indicators of impact on the safety, quality or performance of the IVD products.

2019年8月6日 · 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 …

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.

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 EUL assessment of in vitro diagnostics (IVD) to detect SARS -CoV-2 or anti-SARS-CoV-2 antibodies. These questions and answers

2024年6月13日 · 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 manufacturers and regulatory authorities in low- and middle-income countries (LMICs) with the essential knowledge and guidance needed to promote strategies for product design ...

2023年10月18日 · 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 …

2022年11月18日 · 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 with the participation of worldwide laboratory medicine professionals and nongovernmental organizations (NGOs), and representatives of WHO regional offices, country …

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 ...