Brazil Notivisa Adverse Event Reporting: Who Can File and When

1. Key takeaways

In Brazil, adverse event and technical complaint submissions can only be filed by the registration holder through Notivisa; foreign manufacturers have no channel to open their own account or file on their own — this is the conclusion GRZAN states most often to clients. The direct consequence is that the 72 hours and 10 calendar days clocks of Article 8 of RDC 67/2009 rest entirely on the Brazilian side, and the transmission time between the factory and the holder counts against the deadline.

2. Legal basis

• Technovigilance Regulation — RDC nº 67/2009, published on December 21, 2009 (DOU 2009-12-23), Article 3 single paragraph, Article 8 and Article 10
• Execution and notification of field actions — RDC nº 551/2021, published on August 30, 2021 (DOU), full text
• Classification, notification and registration of medical devices, and labeling and instructions-for-use requirements — RDC nº 751/2022, resolution of September 15, 2022, Article 4, item VIII, Article 13, item II and Article 14, item III
• Operating conditions for companies subject to health licensing — Decreto nº 8.077/2013, signed on August 14, 2013, published in the DOU on August 15, 2013 (Seção 1, p.18) and in force on that date (Article 26), Article 15, §2 (joint liability for quality, safety and efficacy of all parties from manufacturing to consumption), Article 16 single paragraph (adverse events and technical complaints must be reported to ANVISA), Article 24 (violations of this decree constitute health offenses with civil and administrative liability under Lei nº 6.437/1977), Article 25 (repeals Decreto nº 79.094/1977 and Decreto nº 3.961/2001)

3. Expert insights

First insight: Notivisa is a channel, not a rule for allocating responsibility. GRZAN sees many foreign factories treat the question of why they cannot file themselves as a technical issue, when it is in fact a legal structure issue — RDC 67/2009 applies to registration holders with an establishment in Brazil, and the single paragraph of Article 3 binds the responsibility and the channel to the same party. BRH is industry shorthand; the statutory terms are detentor de registro and detentor de notificação.

A related point is the cooperation duty in the holder agreement. GRZAN recommends stating in the manufacturer’s letter of authorization and the quality agreement that the factory must notify the holder immediately upon becoming aware of an event, with content covering at least the place of occurrence, the product model and batch, whether death or serious injury has occurred, and whether interim measures have been taken. The more complete the fields, the less rework on the Brazilian side.

Second insight: responsibility cannot be transferred by contract, but work can. Article 3 requires the holder to answer to health authorities for technical complaints, adverse events, serious threats to public health, alerts and field actions. GRZAN’s recommendation is to write the factory-to-holder notification deadline into the letter of authorization (LOA) and the quality agreement as an auditable clause, so that the statutory 72-hour window is divided internally into smaller segments.

A related point is the availability of historical data. Item III of Article 8 requires judging whether the same type of event caused death or serious health damage within the last two years (the official wording is nos últimos dois anos, often miscopied as three years), which requires a searchable log on the factory side. Article 6, item X, sole paragraph of RDC 67/2009 sets the statutory retention period at no shorter than the expected lifetime of the product and no less than two years from receipt of the notification. GRZAN has seen logs scattered by year, making the determination impossible within 30 calendar days and forcing treatment under the stricter tier.

Third insight: submission language and terminology. Article 10, §9 of RDC 751/2022 requires application forms, instructions for use and label models in Portuguese; vigilance submissions are likewise filed in Portuguese. GRZAN recommends building the event record template bilingually, with the Portuguese version as the only submission version, avoiding deadline consumption on translation loops.

Fourth insight: the legal source of the notification duty sits at the decree level; Notivisa is only the channel for performance. Article 16, single paragraph of Decreto 8.077/2013 provides that adverse events and technical complaints must be reported to ANVISA, and failure to report constitutes a health offense. GRZAN uses this to correct a frequent misunderstanding: companies believe the duty comes from Notivisa or RDC 67/2009, so as long as they open no account and register nothing it does not concern them. The order is exactly the reverse — the decree creates the duty first, the system opens the channel afterwards; not opening an account does not make the duty disappear, it only makes the duty impossible to perform, liability still attaches and Article 24 leads into the sanction list of Lei 6.437/1977. This also explains why responsibility cannot be pushed away: the duty-bearing party is designated by the decree, not chosen at system registration. Going further, Article 15, §2 of Decreto 8.077/2013 extends joint liability explicitly to all parties from manufacturing to consumption — factory, importer, distributor and holder sit on the same chain of responsibility. The factory is not a bystander outside the chain, only another link in it; if any link breaks, the pressure ultimately returns to the holder who answers to ANVISA. So letting the factory file itself has neither a channel nor a legal basis.

4. Practical recommendations

• Fix the internal deadline and format for factory-to-holder event notification in the LOA or the quality agreement.
• Have the holder create and maintain the Notivisa account and operator authorizations; the factory does not hold them directly.
• Build a Portuguese/English parallel event record template, with the Portuguese version as the submission version.
• Designate a single point of contact on each side to avoid multi-channel transmission.
• Fix the notification template fields: place of occurrence, model and batch, severity of outcome, measures already taken.
• Retain the factory-side complaint and event log under Article 6, item X, sole paragraph: no shorter than the expected product lifetime, no less than two years from receipt of the notification, searchable by model.
• Designate backup contacts on both sides so vacations or staff changes do not break the chain.
• Run a mock submission drill once a year to verify the channel, permissions and translation loop.
• Track submitted events through to closure; do not treat filing as the endpoint.

5. Verification checklist

• □ Verify the Notivisa filer matches the registration holder
• □ Verify the internal deadline of the factory-to-holder notification chain is shorter than 72 hours
• □ Verify the Portuguese submission template against the terminology of Article 4 of RDC 67/2009
• □ Verify account permissions and operator authorization records
• □ Verify the factory-side log is searchable by model and covers the last two years
• □ Verify the validity of the backup contact list
• □ Verify that submitted events have reached subsequent closure
• □ Verify the current Notivisa entry path on gov.br/anvisa
• □ Verify that the legal source of the notification duty, Article 16, single paragraph of Decreto 8.077/2013, is written into the internal responsibility matrix

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN helps manufacturers and Brazilian registration holders keep their Notivisa channel, notification chain and vigilance records inspection-ready: from drafting Portuguese submission templates and LOA clauses to running mock submission drills and maintaining event logs that satisfy the retention rules of RDC 67/2009. Wherever your factory sits, we make sure the Brazilian side of the chain never breaks. For technovigilance and reporting support in Brazil, contact info@grzanglobal.com.