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Interdição (Seizure) & Apprehension of Devices

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Interdição (seizure or interdiction) and apreensão (apprehension) are ANVISA enforcement tools that allow physical seizure of non-compliant medical devices or closure of non-compliant facilities — without requiring a court order.

Interdição de produto (product seizure)​

ANVISA or state VISA may physically seize specific batches or all stock of a medical device when:

  • The device presents an immediate and serious risk to public health;
  • The device is unregistered or its registration has been cancelled;
  • The device does not conform to its registered specifications;
  • The device's registration holder has not complied with a compulsory recall order; or
  • The device is found in conditions that compromise its safety (e.g., improper storage, expired).

Seized products are held by ANVISA/VISA pending investigation. The registration holder may appeal and demonstrate compliance to have products released, but ANVISA may order destruction of products that cannot be shown to be compliant.

Interdição de estabelecimento (facility closure)​

In serious cases, ANVISA may order temporary closure of a manufacturing or distribution facility when:

  • The facility presents systemic GMP failures that pose immediate risks;
  • The AFE has been suspended or cancelled; or
  • The company has failed to comply with previous ANVISA enforcement actions.

Facility closure is one of the most serious enforcement actions ANVISA can take and is typically reserved for repeated or egregious violations.

Official sources

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