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.

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.