Queixas Técnicas vs. Adverse Events
ANVISA's Tecnovigilância framework distinguishes between two types of reportable events — adverse events (eventos adversos) and technical complaints (queixas técnicas). Understanding this distinction is important for correct NOTIVISA reporting.
Adverse events (eventos adversos)
An adverse event is any unintended and undesired effect resulting from device use that caused or could have caused harm to a patient, user or third party. This includes:
- Deaths attributable to device use;
- Serious injuries (life-threatening, requiring hospitalisation, or causing permanent damage); and
- Near-miss events that, if they had occurred in a different clinical context, would have caused death or serious injury.
Technical complaints (queixas técnicas)
A technical complaint is a device malfunction, quality deviation, or failure that does not result in patient harm but:
- Could have caused an adverse event in a different clinical context; or
- Represents a deviation from the device's registered specifications or quality standards.
Technical complaints must also be reported via NOTIVISA. They often trigger ANVISA's quality investigation process and may lead to recalls or field safety corrective actions.
Verify all information against official ANVISA sources before making regulatory decisions.