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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 [...]

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 [...]

COFEPRIS, the Mexican regulatory authority, in May 2024 officially announced the approval of the first software as a SaMDmedical device, [...]

In May 2024, the European Medicines Agency (EMA), together with the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh), [...]

As of June 3, 2024, it will be possible to place one's high-risk Medical Devices in Brazil, relying on authorisations [...]

Taking a step back in time, it is recalled that Switzerland has been considered a Third Country for Europe since [...]