Wrapping up January 2025, medical device regulatory developments include new forms for NBs in Europe, new PMS guidance in the UK, an expedited approval partnership between China and Malaysia, and warnings of supply chain disruptions for pediatric patients in the US.

Medical device regulatory developments from the US and Thailand include: final FDA guidance on modular review for premarket approval applications and humanitarian device exemptions, and new expedited regulatory routes for low-risk devices and chronic disease prevention devices in Thailand.

This week, we are reporting on medical device regulatory updates from Canada, Europe, Brazil, and China. China's NMPA released registration review timelines, clarification on MDR and IVDR vigilance terms is now available, and Health Canada updated validation rules for non-eCTD transactions.

To kick off 2025, we bring you a round up of medical device regulatory updates from across Europe and the US, including a new position paper from TEAM-NB on MDR certification processes and numerous guidance updates from the US FDA.