Substantial Equivalence & Literature-Based Evidence
ANVISA applies equivalence assessment to evaluate whether a device has demonstrated safety and performance comparable to a predicate or reference device across three dimensions:
| Dimension | Key criteria |
|---|---|
| Clinical equivalence | Same intended purpose, indication, patient population, user |
| Technical equivalence | Similar design, dimensions, materials, energy type, software |
| Biological equivalence | Same materials in contact with body tissues/fluids |
The output of the clinical evidence process is a Clinical Evaluation Report (CER) summarising the literature search strategy, appraisal of studies, equivalence analysis, and conclusions on safety and performance.
Verify all information against official ANVISA sources before making regulatory decisions.
Predicate devices must be legally marketed in Brazil (via Notificação, Cadastro, or Registro), EU, or FDA with documented clinical safety/performance data. ANVISA requires equivalence across all three dimensions (clinical, technical, biological); a device may not proceed if only two dimensions align. If predicate device materials differ, biocompatibility study results from both materials may be required. Equivalence argumentation should address failure mode analysis and intended use parameters (e.g., patient population age, disease severity, anatomical site).