The Medical Device Policy Division of the Ministry of Food and Drug Safety (MFDS), the South Korean authority responsible for medical devices` regulation, announced the enforcement of the new regulation on in vitro diagnostic (IVD) medical devices. The law No. 163433...
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued the enforcement policy for remote digital pathology devices in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by...
Canada
The Health Canada, the Canadian authority responsible for medical devices regulation, issued guidance describing the way the Interim Order on medical devices, recently issued by the authority, should be applied. The initial document implements a set of additional...
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...
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...
