Post-Registration Changes (Petição de Alteração)

After obtaining ANVISA registration, any changes to the device, manufacturing, or labelling 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.

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.