Clinical Investigations in Brazil (RDC 10/2015)
BR-unique
Brazil regulates clinical investigations of medical devices through RDC 10/2015, a dedicated regulation setting out requirements for investigation design, ethics approval, investigational site qualification, and ANVISA safety reporting, notification and oversight throughout the investigation.
| Requirement | Detail |
|---|---|
| ANVISA notification | Must be notified to ANVISA before commencement |
| Ethics committee (CEP) approval | Required for each investigational site |
| CONEP approval | Required for multicentric studies and certain high-risk investigations |
| GCP compliance | ICH GCP and ANVISA's own GCP resolution |
| REBEC registration | Brazilian Clinical Trials Registry — public disclosure required |
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.
"Investigational device classification: Devices under clinical investigation may be exempted from standard registration requirements while the investigation is ongoing, provided all RDC 10/2015 requirements are met."