Brazil Medical Device Post Market Surveillance and Vigilance
Medical device post-market surveillance and vigilance are required to maintain regulatory compliance in Brazil.
Brazil medical device post market surveillance and vigilance regulations
Post-market surveillance of medical devices is a regulatory requirement to maintain compliance in Brazil. Manufacturers must proactively monitor their device’s field performance for adverse events or malfunctions using a technovigilance system to ensure the continued safety, quality, and efficacy throughout the device lifecycle.
Ideally, manufacturers will identify the potential for an adverse event before it happens. However, if an adverse event does occur, the National System of Health Surveillance (SNVS) must be notified, a process known as vigilance reporting or adverse event reporting. Brazil medical device vigilance requirements vary depending on the severity of the adverse event. Post market reporting can also include Field Safety Corrective Actions (FSCAs), such as product recalls and field safety notices.
Manufacturers must comply with vigilance reporting timelines to avoid penalties from ANVISA, which can be severe. A proactive approach to post-market monitoring is essential.
Two regulations address the activities manufacturers must fulfill to comply with Brazil’s medical device post market surveillance and vigilance requirements:
Resolution RDC No. 67/2009 outlines the key functions of a manufacturer’s postmarket surveillance system as well as vigilance reporting procedures and timelines.
Resolution RDC No. 551/2021 defines the mandatory requirements for the execution and notification of field actions by medical device registration holders in Brazil.
The Brazil Registration Holder (BRH) is primarily responsible for carrying out PMS and vigilance activities. If you don’t have a legal entity in Brazil, you must designate an in-country representative as your BRH. The BRH must also designate one person within the company with college-level training to oversee PMS activities.
Brazil medical device postmarket surveillance requirements
Postmarket surveillance processes and procedures should proactively gather information about malfunctions, adverse events, situations presenting a serious threat to public health, counterfeiting, alerts, and field actions related to your device. PMS procedures intersect with your quality management system (QMS) procedures and risk management system. All aspects of your PMS system should be heavily documented, along with records of all data collected and evaluated from surveillance activities, as SNVS can request your PMS documentation at any time. Be sure to clearly define and document all personnel roles and keep records of personnel training.
In case of a serious adverse event, you should have documented procedures in place to conduct a priority review of the occurrence in preparation to report the event to SNVS within the required timeframe. Keep records of all activities and conclusions from your review.
Brazil medical device vigilance reporting timelines
Adverse events should be reported as quickly as possible and no later than the following deadlines:
Within 72 hours after becoming aware of the following verified events occurring in Brazil (within 10 days if the event occurred in another country):
- Death;
- serious threat to public health;
- counterfeiting.
Within 10 days after becoming aware of the following verified events occurring in Brazil:
- serious adverse events not involving death;
- non-serious adverse events, the re-occurrence of which has the potential to cause a serious adverse event to a patient, user, or other person.
Within 30 days after becoming aware of a verified malfunction that could lead to a serious adverse event in a patient, user, or other person, and:
- the possibility of a recurrence is not remote; or
- an event of the same type has caused or contributed to a death or serious harm to health in the last three years; or
- the registration holder of the product needs, or needed, to perform an action to prevent danger to health; or
- the possibility that a use error was caused by deficient design, labeling, or instructions.
Frequently
Asked Questions
An adverse event involving my device sold in Brazil occurred in another market. Do I need to report it in Brazil?
Probably. The event should be reported if it resulted in a death, serious threat to public health, or is a case of counterfeiting, and you have imported lots or serial numbers affected by the same problem as the original event to Brazil. The reporting timeline is within 10 days of awareness.
Does an adverse event report imply that the manufacturer or BRH is admitting fault or responsibility for the incident?
No. The reporting of adverse events or malfunction to SNVS does not imply immediate responsibility of the registration holder. It is a regulatory obligation but it does not automatically trigger legal action.
Do we need to report all adverse events regardless of the circumstances?
After conducting a thorough review of the event, you may conclude that the event does not need to be reported based on certified verified conditions. For example, if the event occurred because the product was used after its expiration date or it was caused by the condition of the patient, whether pre-existing or acquired during the use of the device (but not because of it). Article 10 of RDC No. 67/2009 addresses more verified conditions in which an event may be exempt from notification requirements.
