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RDC 36/2015 — IVD Registration & Classification

RDC 36/2015 is the primary regulation for in vitro diagnostic devices (IVDs) in Brazil (Produtos para Diagnóstico de Uso In Vitro — PDUI). It establishes:

  • Definition and scope of IVDs regulated by ANVISA;

  • Four-class risk-based IVD classification system (Class I–IV);

  • Registration pathways by class (Notificação, Cadastro, Registro);

  • Technical documentation requirements for each class;

  • Analytical performance requirements (accuracy, precision, linearity, LOD, interference);

  • Clinical performance requirements (sensitivity, specificity);

  • Requirements for point-of-care and self-test IVDs;

  • IVD labelling requirements; and

  • Post-market surveillance obligations for IVDs.

  • RDC 36/2015 — ANVISA

Official sources

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