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RDC 10/2015 — Clinical Investigations

RDC 10/2015 governs the conduct of clinical investigations of medical devices in Brazil. Key provisions:

  • Applicability — which medical device clinical investigations require ANVISA notification;

  • Requirements for the investigation protocol;

  • Investigational site qualification (facilities, investigators, ethics committee);

  • Ethics approval — CEP (local) and CONEP (national) requirements;

  • Informed consent requirements;

  • Safety reporting — serious adverse event reporting during the investigation;

  • REBEC registration (Brazilian Clinical Trials Registry);

  • ANVISA inspection powers during clinical investigations; and

  • Requirements for the final clinical investigation report.

  • RDC 10/2015 — ANVISA

  • REBEC

Official sources

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