Radiation-Emitting Devices
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.
Verify all information against official ANVISA sources before making regulatory decisions.
CNEN (National Nuclear Energy Commission) is the primary regulator for radiological protection policy. IRD (Instituto de Radioproteção e Dosimetria) is CNEN's technical institute and typically conducts the actual oversight and licensing of radiation-emitting medical device facilities.