The Brazilian Health Regulatory Agency (Anvisa) has published its regulation RDC 270/2019. This regulation:
- establishes a notification pathway for Class I medical devices and in vitro devices (IVDs)
- allows qualifying low-risk medical devices to avoid undergoing full ANVISA registration
- will be implemented in May 2019
The effect of the regulation will be to speed up market access for these low-risk devices. A summary of the new regulation by Emergo explains the details of the regulation and some of the ways Anvisa will monitor and enforce the system.