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Interdição (Seizure) & Apprehension by VISA

BR-unique

Interdição is the physical seizure and apprehension of medical devices by ANVISA or state/municipal VISA bodies — a direct enforcement action with no direct parallel in EU, US, AU, SG, or CA frameworks in terms of how frequently it is used.

VISA bodies may order interdição when:

  • Devices are found without valid ANVISA registration;
  • Devices present an immediate and serious risk to public health;
  • Devices are found in non-compliant conditions (improper storage, expired products); or
  • A compulsory recall has been ordered and the registration holder has not complied.

Interdicted devices are physically seized and held by VISA. The registration holder may appeal the interdição and demonstrate compliance to have the devices released, but VISA retains the right to destroy devices that cannot be shown to be compliant.

Official sources

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