MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), UK’s authority responsible for the regulation of medical devices, issued guidance on field safety notices (FSNs). The document is intended to assist medical device manufacturers in preparing 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...
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...
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