IVD Registration Pathway (RDC 36/2015)

IVDs follow the same three-tier structure under RDC 36/2015.

IVD Class	Pathway	Key additional requirements
Class I	Notificação	Basic technical data
Class II	Cadastro	Analytical performance data
Class III	Registro	Full performance evaluation including clinical performance study
Class IV	Registro	Full performance data, reference laboratory data, blood safety evidence

IVD-specific requirements include analytical performance (accuracy, precision, linearity, interference, LOD/LOQ), clinical performance (sensitivity, specificity), stability data, and for Class III/IV a full Performance Evaluation Report (PER).

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.

Performance Evaluation Reports (PER) must follow RDC 36/2015 guidance and include documented protocols, statistical analysis plans, and full analytical and clinical validation data. For in vitro diagnostic devices, comparison with established reference methods or predicate devices may be required.