Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) requires medical device manufacturers selling in Brazil to comply with a technovigilance system for post-market monitoring and field safety corrective actions. You can reference Resolution RDC No. 67/2009 and Resolution RDC No. 23/2012 for valuable information on terminology, timelines and other technovigilance reporting requirements in Brazil.
Companies that fail to accurately report incidents could face severe financial penalties or criminal sentences. Ignorance is not an acceptable excuse for not reporting incidents, so you must be proactive.
When are vigilance reports required?
An Adverse event must be reported if a device malfunction, deterioration in device performance, or inadequate instructions 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.
You, as the device manufacturer, and your Brazil Registration Holder, 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 corrective action that must be taken.
The process of report adverse events to ANVISA in Brazil
Shown below are the basic steps you should follow in reporting an adverse event in Brazil:
- Reference Resolution RDC No. 67/2009, and Resolution RDC No. 23/2012 for the correct reporting timeline, which will depend on the severity of the incident.
- Inform your Brazilian Registration Holder and 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 feature of the event.
- Distribute an alert message to consumers if 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 to assist with Brazil vigilance reporting?
We have an extensive team of regulatory specialists in the capital city of Brasilia experienced and ready to assist with your vigilance needs. Emergo represents numerous medical device and IVD companies as 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.
Please contact us for more information on how we can assist you with medical device vigilance reporting for Brazil.