To help you navigate the Brazilian Health Regulatory Agency’s (ANVISA) latest updates for in vitro diagnostics (IVDs) and the implications for your healthcare products, we highly recommend you review this detailed report by Patricia Urakawa, Senior Consultant of Regulatory Affairs at Emergo by UL.
This invaluable resource explains several critical updates to RDC 830/2023 that you should be aware of, including:
- IVD classification and re-authorization
- Regulatory submission changes
- New IVD labeling requirements
And more. Read the full report here.
