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...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation...
Europe
MHRA Guidance on Medicines and Medical Devices The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical devices regulation, published updated guidance on distinguishing medicines and medical devices in controversial...
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...
South America
Argentina informs about more upcoming changes in their medical device registration procedures. The appropriate amendments would be implemented in two consecutive steps: on March 6, 2020, and on March 16, 2020, respectively. In particular, the amendments are set forth...
Uncategorized
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulations, issued detailed and exhaustive research dedicated to the timeframes of procedures related to the medical device registration process describing the typical...
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