In vitro diagnostics - Global - World Health Organization (WHO)
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 …
Selection, access and use of in vitro diagnostics
It is expected that national essential diagnostics lists will provide similar benefits and improve access to essential in vitro diagnostic tests. It will also contribute towards health systems …
The selection and use of essential in vitro diagnostics: report of the ...
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 …
In vitro diagnostics for COVID-19 - World Health Organization …
2021年6月14日 · WHO Emergency Use Listing (EUL) for in vitro diagnostics WHO / Blink Media - Lisette Poole Patient tested in the COVID-19 Health Centre at the Central de Abasto, main …
WHO releases new list of essential diagnostics; new …
2023年10月19日 · Updated biennially, the Essential Diagnostics List is intended to support national in vitro diagnostics policy development and to improve access to IVD testing and …
The selection and use of essential in vitro diagnostics - TRS 1031
2021年1月29日 · The group also oversees maintenance of the WHO Model List of Essential In Vitro Diagnostics (EDL), which serves as an evidence-based reference point for countries to …
Emergency Use Listing Procedure for in vitro diagnostics
The WHO Emergency Use Listing (EUL) is open to candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2 (originally called 2019-nCoV). Since 28 February 2020, manufacturers of IVDs …
WHO Global Model Regulatory Framework for Medical Devices …
2017年9月5日 · Overview . The Model recommends guiding principles, harmonized definitions and specifies the attributes of effective and efficient regulation, to be embodied within binding …
WHO Global Model Regulatory Framework for medical devices …
2023年3月22日 · This revised GMRF recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulations to be embodied within binding …
10.4 In vitro equivalence testing for non-oral dosage forms 227 10.5 In vitro equivalence testing for scale-up and post-approval changes 229 References 229 Appendix 1 Recommendations …