In vitro diagnostics - Global - World Health Organization (WHO)
2020年2月10日 · Over 40 000 products are available today for in vitro diagnostic testing, covering a wide range of conditions. These include traditional laboratory-based tests, with samples …
WHO Global Model Regulatory Framework for Medical Devices …
2017年9月5日 · WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices - Select language - العربية 中文 français русский español português …
WHO Global Model Regulatory Framework for medical devices …
2023年3月22日 · Its main elements are derived from international regulatory harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its …
Selection, access and use of in vitro diagnostics
2021年1月28日 · The WHO Essential Diagnostic List (EDL) aims to provide evidence-based guidance and set a reference for the development or update of national lists of essential in …
Medical devices - World Health Organization (WHO)
2024年6月16日 · WHO’s “Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices” supports Member States to develop and implement …
In vitro diagnostics for COVID-19 - World Health Organization …
2021年6月14日 · Rapid diagnostic tests (RDT) for the detection of SARS-CoV-2 antigens; other platforms to detect SARS-CoV-2 antigen will be considered on a case-by-case basis; The EUL …
TRS 1003 - Annex 4: WHO Global Model Regulatory Framework …
2017年10月10日 · TRS 1003 - Annex 4: WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices Annex 4, WHO Technical Report Series, …
2020年8月3日 · Regulatory Framework for Medical Devices,11 including in vitro diagnostic medical 12 devices, like many other international regulatory frameworks, requires the …
Guidance for post-market surveillance and market surveillance of ...
2021年6月20日 · Post-market surveillance is a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have been placed on the …
WHO invites manufacturers of In vitro diagnostic (IVD) medical …
2022年9月7日 · To support the global effort to end the TB epidemic, through the provision of guidance to interested United Nations (UN) and other agencies and WHO Member States in …