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Uso Compassivo (Compassionate Use)

BR-unique

Uso Compassivo (Compassionate Use) in Brazil allows patients with serious or life-threatening conditions to access medical devices not yet registered with ANVISA, when no adequate registered alternative exists. It is regulated by ANVISA and requires case-by-case authorisation.

When Uso Compassivo applies​

Uso Compassivo may be authorised when:

  • The patient has a serious, life-threatening, or debilitating condition;
  • No registered medical device provides adequate treatment;
  • The device has demonstrated promising efficacy and safety in clinical trials or published studies; and
  • A qualified physician requests the use on behalf of a specific patient.

Process for Uso Compassivo​

  1. The treating physician or healthcare institution submits a request to ANVISA.
  2. ANVISA evaluates the request — considering the severity of the condition, the evidence for the device, and the risk-benefit balance.
  3. If authorised, ANVISA issues a case-specific authorisation.
  4. The device is imported or supplied under the authorisation (not a general registration).
  5. The physician must report any adverse events to NOTIVISA.

Relationship to product registration​

Uso Compassivo is not a pathway to full product registration. Manufacturers wishing to commercially market a device in Brazil must still obtain a standard Registro/Cadastro/Notificação through the regular registration process.

Official sources

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