ANSWERED ON THIS PAGE:
- What is considered an adverse event in Brazil?
- When are medical device vigilance reports required in Brazil?
- What is the ANVISA adverse event reporting process for medical devices?
The importance of complying with Brazil's medical device adverse event reporting requirements
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. Resolution RDC No. 67/2009 and Resolution RDC No. 551/2021 both provide critical information on terminology, timelines, and other technovigilance reporting requirements in Brazil.
Companies that fail to accurately report incidents could face severe penalties. Ignorance is not an acceptable excuse for not reporting incidents, so manufacturers must be proactive.
When are medical device vigilance reports required in Brazil?
An adverse event must be reported if a device malfunction or misuse results in:
- death or serious injury, or
- could lead to death or serious injury if it were to recur, or
- in other applicable circumstances, as described in the regulation.
As the device manufacturer, you and your Brazil Registration Holder (BRH) are responsible for reporting adverse events to the National Sanitary Surveillance System (SNVS). 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.
Reporting medical device adverse events to ANVISA
Shown below are the basic steps you should follow to report an adverse event in Brazil:
- Reference Resolution RDC No. 67/2009, and Resolution RDC No. 551/2021 for the correct reporting timeline, which will depend on the severity of the incident.
- Inform your Brazil Registration Holder and the National Sanitary Surveillance System (SNVS) that a reportable adverse event has occurred.
- Inform your Registration Holder and ANVISA if a field safety action is necessary.
- Notify ANVISA in compliance with the applicable timeline depending on the nature of the event.
- Distribute an alert message to consumers when the field safety action is taken.
- Submit monitoring reports and final adverse event reports to SNVS and ANVISA.
- Add all reports to ISO 13485 or other quality system records.
Why choose Emergo by UL to assist with Brazil vigilance reporting?
Emergo represents numerous medical device and IVD companies as a Brazil Registration Holder, and our team is frequently involved with incident reporting to ANVISA. Here’s why it makes sense to work with us:
- If we act as your Registration Holder, our team in Brazil can submit adverse event reports and recall information to the National Sanitary Surveillance System on your behalf.
- Our experienced consultants can help determine when incidents are reportable and ensure that final incident reports to ANVISA are completed on time.
- We have experience assisting numerous manufacturers with post market surveillance, ANVISA registration, and other regulatory consulting services.
We have an extensive team of regulatory specialists in the capital city of Brasília who are experienced and ready to assist with your vigilance needs.