ANVISA Postmarket Surveillance & Vigilance

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.

From a safety signal to documented action

Apply the actual RDC 67/2009 event definitions and the separate RDC 551/2021 field-action process. Do not wait for a finished root-cause analysis if a reporting deadline is running. A foreign event requires assessment of Brazilian product exposure and the applicable trigger, rather than an automatic assumption that location removes the duty. Connect actions to labeling and the Brazil holder.