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. EU MDR Clinical Evaluation Reports (CERs) are a useful foundation for ANVISA Class III/IV submissions. Population differences may require supplementary Brazilian clinical data.

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Official sources

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