Radiation-Emitting Devices
BR-unique
Radiation-emitting medical devices are subject to dual oversight: ANVISA regulates the device as a medical device under RDC 56/2001, while CNEN (Comissão Nacional de Energia Nuclear) and its institute IRD regulate radiological protection and facility licensing.
Beyond ANVISA registration, facilities using radiation-emitting devices must obtain a CNEN operating licence, perform periodic equipment calibration, and appoint a radiation protection supervisor (Supervisor de Radioproteção) at each facility.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.