New Regulation Harmonizes Brazilian Clinical Testing Requirements with International Standards
ANVISA, Brazil’s medical device market regulatory agency, has published new requirements for conducting clinical testing of devices in the country.
The new regulation, RDC 10/2015 (link in Portuguese), establishes procedures and processes required to perform clinical testing, and also introduces clinical testing petitions that will need to be submitted to ANVISA in cases where such testing of Class III or IV devices or devices intended for diagnostic purposes will be required. (IVD devices are not included under the scope of RDC 10/2015.)
RDC 10/2105 adopts a clinical testing approach more harmonized with international standards and agencies, with a stronger focus on technical documentation submissions and good clinical practices. By implementing the new regulation, ANVISA is attempting to boost Brazil’s profile as a viable destination for medical device clinical testing efforts and activities.
Previous regulations now revoked by RDC 10/2015 include RDC 39/2008, RDC 36/2012 and certain clauses in RDC 81/2008.
Emergo’s office in Brasilia will provide further analysis of the new ANVISA clinical testing requirements in the near future.
To learn more about Brazil's medical device registration and approval process, see our video overview of ANVISA registration requirements.