Using Foreign Clinical Data
ANVISA generally accepts foreign clinical data provided it was conducted in accordance with ICH GCP, the study population is representative of the Brazilian patient population, the data is from a peer-reviewed publication or regulatory submission (FDA PMA, EU MDR CER, TGA), and the study addresses the same intended use.
FDA PMA clinical data is generally highly accepted by ANVISA for Class IV devices, provided the FDA indication/intended use aligns with the proposed Brazilian indication and the patient population is comparable to the Brazilian target population. EU MDR Clinical Evaluation Reports (CERs) are a useful foundation for ANVISA Class III/IV submissions. Population differences may require supplementary Brazilian clinical data.
Verify all information against official ANVISA sources before making regulatory decisions.
Data age may be relevant to ANVISA review; generally, clinical data not older than 5–10 years is preferred. Supplementary Brazilian clinical data is typically required for Class IV devices or when patient population demographics, disease prevalence, or healthcare practices differ materially from the source population.
Population representativeness should consider: age distribution, ethnicity, comorbidity profiles, disease severity, and healthcare setting (public vs. private system). Material differences typically include disease prevalence >20% variance, different genetic/ethnic composition >15%, or healthcare practice differences affecting device performance (e.g., different anticoagulation protocols for thrombosis studies). When such differences exist, ANVISA may require bridging studies with 30–50 Brazilian subjects or focused subgroup analysis from foreign datasets.