Peru joins IMDRF, updated clinical trial guidance in Denmark, Romania implements new compliance requirements for professionals users, and more in this week's medical device regulatory update.

Ensuring compliance across various jurisdictions can be challenging, but advances in artificial intelligence (AI) are changing the way companies in the medtech sector function.

The co-founder of Pure Global discusses the regulatory consultancy's use of AI to support clients’ marketing submissions and other needs, as well as the AI-enabled medtech landscape and opportunities in China and Southeast Asia for accessing patient data for AI development purposes.

This week in medical device regulatory news: updated guidance on MDR requirements for legacy devices, China released new product guidelines, revised UK guidance on Conditional Marketing Authorizations, and more.

As the MedTech markets expand globally, the need for user-centered design has never been greater. According to the FDA, human factors engineering (HFE) and usability engineering (UE) focus on studying how people interact with technology and how user interface design impacts medical device interactions.

This week in medical device regulatory news: Brazil expedites registration of IVDs for mosquito-born diseases; new US FDA guidance on endosseous dental implants and abutments.

Our first round-up of October 2024 medical device regulatory updates includes new CLSI guidelines and an upcoming webinar in the US, new MDCG guidance documents in Europe, and new industry standards from the NMPA in China.

End of September 2024 brought updates from major markets: EU IVDR transition guidance for Class D IVDs, biocompatibility guidance from the US FDA, IVD family grouping regulations from Brazil, and more.

Medical device regulatory news from the Americas includes enhanced safety and performance standards in Brazil; new device classifications from the US FDA; and a policy for classifying combination products in Canada.