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In Brief: Brazil’s ANVISA Updates Modification Process for Lower-risk Cadastro Devices


Brazilian medical device market regulators have eased requirements for making changes to lower-risk or cadastro registrations for medical devices and IVDs.

ANVISA cadastro medical device and IVD registrationAccording 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.

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