Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With updated compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?

In this week's regulatory update, we bring you news from Brazil and China, including new guidelines for medical device clinical trial inspections from China's NMPA and the availability of medical device price monitoring data on ANVISA's Business Intelligence dashboards.

This week's round up of medical device regulatory news covers digital advancements, including the official publication of the Regulation on the European Health Data Space (EHDS) in the EU and the introduction of Avisalegis, a subscription-based notification service that alerts users about new regulatory publications in Brazil.

What will the regulatory environment look like this year? How can medtech manufacturers set business goals or seize opportunities for new market growth?

This week in global medical device news: Brazil's ANVISA goes 100% digital, more Approved Bodies in the UK, revised guidance on HIV self-test kits in Malaysia, and more.

The fifth revision to the EU's guidance on Notified Body requirements under the MDR and IVDR has been released. Canada published new guidance on machine learning-enabled devices, findings from China's Medical Device Standards Management Annual Report, and more in this week's round-up of medical device regulatory news.

Oliver Eikenberg describes his work as a consultant in regulatory affairs for in vitro diagnostic devices.

To close out January 2025, we are reporting on medical device regulatory developments in the European Union and Switzerland, including IVDR compliance challenges cited in the MedTech Europe 2024 Regulatory Survey, as well as guidance, FAQ, and form updates from Swissmedic.

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.