Navigate Brazil UDI Requirements

The presenters will provide more details on ANVISA’s regulatory agenda, as well as our perspective on the UDI requirements, including the latest updates.

Our team provides updates on the entire process:

• Updates on the topics that will become regulations or revisions to existing regulations such as Brazilian Good Manufacturing Practice (BGMP) certificate validity based on health risk and the impact on device registration, electronic indications for use (e-IFU) for lay use, IVD regulation covering INCQS testing updates and more that are covered by the ANVISA regulatory agenda 2024-2025.
• Updates on UDI requirements including – marking requirements, the UDI system deadline in Brazil (responsibilities and which entities must submit UDI information) as well as what should be in place for the upcoming deadline in July for Class IV medical devices.

Tune in to learn more about the latest Brazil regulatory updates and how we can help you bring safer and more effective medical devices to market.