Apr 19, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published guidance dedicated to in vitro diagnostic (IVD) self-tests intended to be used for diagnosing seasonal...
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Apr 5, 2021
EU MDR/IVDR
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document detailing how medical device accessories should be described in submissions. The document also provides additional...
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Apr 2, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of the representatives of all Member States, has published a questions and answers document dedicated to custom-made medical devices. The document also describes the...
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Apr 9, 2019
Australia and Oceania
The Australian regulatory authority, the TGA, is taking steps to improve the existing regulation in the sphere of manufacturing and use of medical devices through what is known as the “Action Plan”. The main goal of the Action Plan, published on April 4, 2019, is to...
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Mar 28, 2019
North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
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