Connect and stay on top of the MedTech regulatory landscape globally.

This week in medical device regulatory news, the European Commission has updated official guidance on the classification of IVDs under the IVDR; Brazil has opened public consultation on UDI database management and suspended electronic signature requirements; and China revised its regulations on domestic production of imported medical devices.

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.

Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website.

Unlock efficient market access with Pure Global & MEDIcept's collaboration. From registration to regulatory expertise, we offer comprehensive solutions worldwide. Drive growth & innovation in MedTech.

Malaysia, a key gateway to Southeast Asia, offers strategic access for businesses. Understanding medical device regulations is crucial for market entry.

In the dynamic world of MedTech compliance, AI plays a pivotal role. It streamlines regulatory research, enhances data analytics for compliance, and automates tasks, ensuring efficiency and accuracy. Looking ahead, AI-driven digital tools promise even greater efficiency, enabling global collaboration and driving the MedTech industry towards innovation and growth.