By Stewart Eisenhart, Emergo Group
Brazilian medical device market regulators have eased requirements for making changes to lower-risk or cadastro registrations for medical devices and IVDs.
According to a Technical Note (link in Portuguese) issued by ANVISA, Brazilian market participants seeking to make multiple modifications to their cadastro registrations may now submit all proposed changes to regulators using a single application form; ANVISA will also no longer charge a review fee for modification applications for cadastro devices, the Technical Note states.
Furthermore, the Technical Note makes no mention of modifications to higher-risk registro registrations, so all fees and application processes pertaining to these devices remain in place at ANVISA.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.