Marketing Medical Devices Worldwide: Questions and Answers
Over the past few months, through the Thema HelpDesk service, we have received numerous questions regarding the international regulation of medical [...]
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, 24 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 [...]
As of June 3, 2024, the 'Guidance document Incident Economic Operators' is valid in Switzerland. This is a document that [...]
On July 2, 2024, the Medical Device Coordination Group (MDCG) published the updated version of the 'Guidance on standardisation for [...]
On July 9, 2024, Regulation (EU) 2024/1860 of the European Parliament and of the Council amending the European Regulation on [...]