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IVD Registration Pathway (RDC 36/2015)

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

IVD ClassPathwayKey additional requirements
Class INotificaçãoBasic technical data
Class IICadastroAnalytical performance data
Class IIIRegistroFull performance evaluation including clinical performance study
Class IVRegistroFull 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).

Official sources

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

Performance Evaluation Reports (PER) for Class III/IV IVDs must follow RDC 36/2015 guidance and include: documented study protocols, statistical analysis plans (including sample size justification), full analytical and clinical validation data, quality control specifications, and stability data under real-world storage conditions. PERs typically range from 50–150 pages depending on complexity. For in vitro diagnostic devices, comparison with established reference methods or predicate devices may be required.

For Class IV IVDs (particularly blood screening assays), reference laboratory data must include: comparative testing against FDA-cleared or CE-marked predicate devices, validation in reference laboratories with proficiency testing results, and demonstration of performance across regional blood donor demographics. Blood safety evidence requires documentation of sensitivity >99.9% for relevant pathogens (HIV, HBV, HCV as applicable), specificity >99.5%, and post-market surveillance protocols for rare false negatives.

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.