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) 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...
North America
The US Food and Drug Administration (FDA), the authority responsible for medical devices regulation, issued guidance dedicated to 510(k) premarket notification submissions for Electrosurgical devices for general surgery. The scope of the document covers devices based...
Asia
Japan announced the adoption of the new version of the Pharmaceuticals and Medical Devices (PMD) Act, the core document regulating the Japanese sphere of medicines and medical devices. New Japanese Medical Device Regulations: an Overview The novelties introduced in...
Europe
One of the most significant steps made in 2019 in Montenegro surrounding the medical device regulatory framework was the adoption of the Law on Medical Devices. This established general principles related to manufacturing, distributing and supervising medical devices...
