Technovigilance &
Adverse Event Reporting

Complying with Brazil's medical device adverse event reporting requirements is of outmost importance if you want to maintain your product in the market. 

​

Brazil’s National Health Surveillance Agency (ANVISA) requires medical device manufacturers selling in the country to comply with a technovigilance system for post-market monitoring and field safety corrective actions. Resolutions RDC No. 67/2009 and RDC No. 551/2021 provide critical information on terminology, timelines, and other technovigilance reporting requirements in Brazil.

​

Companies that fail to accurately report incidents could face severe penalties. Unawareness is not an acceptable excuse for not reporting incidents, so manufacturers must be proactive. As the device manufacturer, you and your Brazilian Registration Holder (BRH) are equally responsible for reporting adverse events to ANVISA.

​

An adverse event report (also known as "Notivisa") must be submitted if a device malfunction or misuse results in death or serious injury, could lead to death or to serious injury if it were to recur, or in other applicable circumstances, as described in the regulation. A technical complaint must also be reported under certain circumstances if a reoccurrence could lead to a severe adverse event.

​

Manufacturers must notify ANVISA if a field safety action or recall is necessary to reduce the risk of death or serious injury. An alert must also be reported to ANVISA and distributed to consumers detailing the necessary corrective action.

​

To report an adverse event to ANVISA, you must first inform your BRH that a reportable adverse event has occurred and if a field action is necessary, obeying the applicable timeline depending on the nature of the event.