IVD Classification (RDC 36/2015)
IVDs are classified under RDC 36/2015 using a separate four-class risk-based system.
IVD classification matrix
Class IV → High → High → HIV screening tests, blood grouping reagents, nucleic acid testing (NAT) for blood screening, and blood transfusion screening tests
Classification factors: intended use, risk of false results, technological risk, and population screened.
Registration pathways: Class I → Notificação | Class II → Cadastro | Class III/IV → Registro
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.