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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.

Note: Clinical investigations under RDC 10/2015 are required primarily for Class III and IV devices and certain Class II devices. Requirements vary by device type and intended use. Consult ANVISA guidance or the classification catalogue (IN 57/2022) to determine if a clinical investigation is mandatory for your device.