News

18/10/2024 On October 1, 2024, the FDA's Centre for Devices and Radiological Health (CDRH) in the US announced that devices with [...]

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 [...]

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, [...]