This report (30 August 2024) provides details on the status of various medical device regulations, as self-identified by IMDRF members. It covers documents on key areas like Software as a Medical Device (SaMD), Unique Device Identification (UDI), regulatory pathways for personalized medical devices, and medical device cybersecurity. Countries such as Brazil, Canada, the EU, China, and the USA have implemented or partly implemented these documents, with variations across regions. The report reflects the global efforts toward regulatory convergence in medical device standards…
