In Australia, the Essential Principles represent a set of mandatory requirements designed to ensure that Medical Devices placed on the market [...]
The US Food and Drug Administration (FDA) recently announced in a guidance issued on August 23, 2024, entitled 'Electronic Submission Template [...]
Machine Learning-Enabled Medical Devices (MLMD) represent a revolution in healthcare. These Medical Devices, based on artificial intelligence and machine learning, assist [...]
Over the past few months, through the Thema HelpDesk service, we have received numerous questions regarding the international regulation of medical [...]
On July 3, 2024, Regulation SOR 2024-136 was published in the Canada Gazette, an update that makes significant changes to SOR/98-282 [...]
On July 31, 2024, the U.S. Food and Drug Administration (FDA) officially announced in the Federal Register the new medical device [...]
The European Commission has made available the final text of the Artificial Intelligence Act (AIA), the world's first comprehensive regulatory framework [...]
October, 25 2024 | 11-12pm (ET)
November 27, 2024 | 11-12pm (ET)
There are products with substances, among the so-called 'borderline' substances, for which the identification of the correct legal context is not [...]
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