Brazil recently extended the registration period for high-risk Class III and Class IV devices and in vitro diagnostics from five years to 10 years, and Marcelo do Ó, managing director and partner at L.E.K. Consulting, in São Paulo, Brazil, talked with FDAnews about the implications of the change.
According to ANVISA, Brazil’s National Surveillance Agency, 94 percent of device renewals are approved, and this control does not release the need for the initial approval, modification approval and technology vigilance processes, he said.
The extension from five years to 10 years for renewal should not be confused with lack of control procedures, since they continue in place, he noted, adding that some countries, including Australia and the U.S., do not require renewals.
For classes III and IV, it is important to note that there is a reasonable level of rigor to approve the product in the first place. So as long as there is no material modification or negative techno vigilance data, the product safety should be secured from the moment the analysis was conducted for the initial registration, he said.