Emergency Authorisation — Medida Cautelar
A Medida Cautelar (precautionary measure) can be issued by ANVISA in emergency situations — either to authorise emergency use of an unregistered device, or to suspend/prohibit a registered device that presents an urgent safety risk.
Medida Cautelar for emergency authorisation
During a public health emergency (as declared by the Ministry of Health), ANVISA may issue a Medida Cautelar to:
- Temporarily authorise the import and use of medical devices not yet registered in Brazil;
- Expedite the registration review for urgently needed devices; or
- Authorise temporary use of devices under a simplified documentation package.
This mechanism was extensively used during the COVID-19 pandemic (2020–2022) under Lei 13.979/2020 to rapidly authorise ventilators, oxygen concentrators, COVID-19 diagnostic tests, and personal protective equipment.
Medida Cautelar for safety suspension
ANVISA may also use a Medida Cautelar to immediately suspend the sale and use of a registered device that presents an urgent risk to public health — without going through the full recall process. This is the fastest enforcement tool available to ANVISA.
Verify all information against official ANVISA sources before making regulatory decisions.