![IFU for Reusable and Re-sterilizable Devices](https://www.regdesk.co/wp-content/uploads/2020/01/ec.jpg)
Jul 29, 2020
EU MDR/IVDR
The Compliance and Enforcement Group (COEN), an EU body focused on the sphere of information exchange between market surveillance authorities and coordination of enforcement activities, has issued a checklist dedicated to the instructions for use (IFU) for reusable...
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![An Overview of South Korea and Their Medical Devices](https://www.regdesk.co/wp-content/uploads/2019/11/south-korea-flag-std-800x675.jpg)
May 13, 2020
Asia
The Ministry of Food and Drug Safety (MFDS), the South Korean authority responsible for medical devices regulation, published a brochure providing an overview of the existing regulatory framework. The document covers the most important aspects related to medical...
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![FDA Enforcement Policy for Telethermographic Systems](https://www.regdesk.co/wp-content/uploads/2020/03/kU8p7iWI_400x400.jpg)
Apr 22, 2020
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued an enforcement policy dedicated to the telethermographic systems in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused...
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![FDA Guidance on Digital Health Devices](https://www.regdesk.co/wp-content/uploads/2020/03/FDA-guidance.jpg)
Apr 20, 2020
FDA
The Food and Drug Administration (FDA) issued guidance dedicated to the digital health devices used to treat psychiatric disorders in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus” and...
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![EC Guidance on Medical Devices in the COVID-19 Context](https://www.regdesk.co/wp-content/uploads/2019/11/mdcg.jpg)
Apr 7, 2020
COVID-19
The European Commission (EC), the European authority responsible for medical devices regulation, issued guidance dedicated to medical devices, active implantable medical devices, and in vitro diagnostic medical devices in the context of Coronavirus Disease 2019...
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