Asia The first article describes the regulatory background for labeling requirements, provides definitions of key terms, and also highlights the main points related to the general requirements for labeling including the way the safety and use-related information should be...
Asia The Health Sciences Authority (HSA), Singapore’s regulating agency in the sphere of healthcare products, has published a guidance document dedicated to software medical devices. In particular, the document describes a life cycle approach and the way it should be...
Europe The Russian Federation issued several regulations implementing additional measures to ensure and expand the availability of medical devices that are vitally important during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the...
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...
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...
