Substantial Equivalence & Literature-Based Evidence
ANVISA applies equivalence criteria similar to the EU MDR framework 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.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.