Post-Registration Changes (Petição de Alteração)
After obtaining ANVISA registration, any changes to the device, manufacturing, or labelling, intended use (Change Request) The regulatory treatment depends on whether changes are classified as major (pre-approval required) or minor (notify after implementation). must be managed through a Petição de Alteração submitted via Peticionamento Eletrônico.
Major changes (require ANVISA approval before implementation): Changes to intended use or indications; new device models; changes to critical materials; changes to sterilisation method; manufacturing site changes (Class III/IV).
Minor changes (implement then notify ANVISA): Editorial corrections to labelling; addition of a new language to IFU (where Portuguese is maintained); minor packaging changes not affecting device integrity.
Verify all information against official ANVISA sources before making regulatory decisions.
Note: Manufacturing site changes are classified as major changes only for Class III and Class IV devices. For Class I and II devices, manufacturing site changes may follow different procedures — confirm current requirements with ANVISA.