News

22/11/2024 In the wake of the increasing technological development in the medical device sector, the Saudi Food and Drug Authority (SFDA) [...]

22/11/2024 In October 2024, the Medical Device Coordination Group (MDCG) published the updated version of MDCG Guideline 2022-5 Rev. 1, entitled [...]

18/10/2024 On October 8, 2024, the Medical Device Coordination Group (MDCG) of the European Commission published the MDCG 2024-11 - Guidance [...]

18/10/2024 On September 15, 2024, the FDA updated three draft guidelines related to ASCA (Basic Safety and Essential Performance), a voluntary [...]

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 [...]