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Cancelamento de Registro — Registration Cancellation

Cancelamento de Registro (registration cancellation) is ANVISA's most severe pre-market enforcement action — the permanent revocation of a device's marketing authorisation in Brazil.

When ANVISA may cancel a registration​

ANVISA may initiate cancelamento de registro when:

  • The registered device is found to present an unacceptable risk to public health that cannot be adequately mitigated;
  • The registration holder has materially misrepresented information in the registration dossier;
  • The device is no longer manufactured, imported or available and the registration holder requests cancellation;
  • The registration holder has not complied with ANVISA's compulsory recall order after repeated notices;
  • The GMP certificate (CBPF) has lapsed and cannot be renewed; or
  • The AFE of the registration holder has been permanently cancelled.

Process for cancellation​

  1. ANVISA initiates an administrative proceeding (processo administrativo) — the registration holder is notified.
  2. The registration holder has the right to present a defence.
  3. ANVISA's collegiate board issues a decision.
  4. If cancellation is upheld, it is published in the Diário Oficial da União (DOU).
  5. The registration holder must immediately cease distribution and implement a recall of all stock.
  6. The registration holder may appeal through the administrative appeals process and, ultimately, judicial review.
Official sources

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