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Registration Validity — 10 Years & Renewal

BR-unique

All ANVISA product registrations are valid for 10 years — longer than EU MDR certificates (5 years).

Renewal must be initiated before expiry via Peticionamento Eletrônico. A missed renewal means the registration lapses. Renewal requires updated technical documentation, current CBPF certificate, current AFE, and payment of renewal fee.

Post-registration changes (Petição de Alteração)​

  • Major changes (alterações maiores): require ANVISA review before implementation — new intended use, new model variants, critical material changes, sterilisation method changes, manufacturing site changes for Class III/IV.
  • Minor changes (alterações menores): implement then notify ANVISA — editorial label corrections, minor packaging changes.
Official sources

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