Brazil Field Actions: Execution and Notification under RDC 551/2021

1. Key takeaways

The execution and notification obligations for field actions (Ação de Campo) are set by RDC 551/2021, published on August 30, 2021, and the distribution and use chain bears joint liability for the effectiveness of the action — this is the single judgment GRZAN most wants foreign factories to remember. A field action often starts at the same time as the 72-hour reporting clock of Article 8 of RDC 67/2009; if a company puts all of its energy into filling out forms, it will lose points on the execution side.

2. Legal basis

• Execution and notification of field actions — RDC nº 551/2021, published on August 30, 2021 (DOU, in.gov.br), full text (execution and notification obligations)
• Technovigilance Regulation — RDC nº 67/2009, published on December 21, 2009 (DOU 2009-12-23), Article 4 and Article 8
• 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 25 and Article 26

3. Expert insights

Joint liability is the part of RDC 551/2021 most easily underestimated. GRZAN’s reading is that ANVISA does not accept a notice sent to distributors as proof that the obligation has been fulfilled; instead, the distribution and use chain as a whole is pulled into the same web of responsibility. This means the registration holder must be able to prove that the action penetrated to the end users — hospitals, clinics, and the final users of products already sold.

The second related point is the import stage. Article 60, §1 of RDC 751/2022 provides that industrialization, import, display for sale or delivery to consumers must not occur before publication in the DOU. Once a field action involves stopping imports or sealing stock, the import compliance path must be adjusted at the same time; otherwise the contradictory state of a notified stop with fresh clearances still occurring will arise. GRZAN recommends notifying the customs and logistics teams on the very day the action is launched.

The third point is the division of labor between field actions and technovigilance. Article 4 of RDC 67/2009 lists field actions as a component of the vigilance system, and Article 8 sets the reporting rhythm of 72 hours and 30 calendar days. GRZAN recommends treating the two as one production line: the vigilance submission solves letting ANVISA know, while the field action solves stopping the risk; neither can substitute for the other.

The fourth point is the boundary with the inventory depletion rules. Packaging, labeling and instructions-for-use stock left over after an approved change may be depleted within 120 days (RDC 751/2022, Articles 25 and 26), but changes involving safety or performance issues do not qualify for this window — such cases should go through a field action rather than waiting for stock to run down naturally. GRZAN has seen safety defects dressed up as inventory depletion in projects, which carries a very high risk. A common further mistake is to confuse finished products already inside Brazil with stock still awaiting shipment abroad, which blurs the scope of execution and leaves end-user notification incomplete.

The fifth point is who holds the right to launch. The obligations of execution and notification fall on the registration holder, and the holder is often an importer or local entity authorized through a manufacturer’s letter of authorization. GRZAN recommends writing the launch right, cost bearing and the scope of information disclosure into the agreement at the start of the cooperation, so that when a risk emerges the parties do not negotiate first and act later, burning the 72-hour window on internal coordination.

4. Practical recommendations

GRZAN adds one point on evidence. The official text of RDC 551/2021 is accessible at in.gov.br (resolucao-rdc-n-551-de-30-de-agosto-de-2021). This resolution, published on August 30, 2021, is not long, yet it makes both execution and notification mandatory obligations. The most common way companies lose points is notifying without verifying execution: notification is a one-way act while execution is a closed-loop act, and their evidence takes different forms — the former needs proof of delivery, the latter needs recovery rates and end-user confirmation rates. Without the latter, the effectiveness of the action remains unproven.

• Maintain in advance a list of the Brazilian distribution and use chain, including second-tier distributors and key end-user institutions.
• Issue field action letters in Portuguese, and retain proof of delivery and execution confirmations.
• Set effectiveness verification indicators (recovery rate, replacement rate, end-user confirmation rate) and keep them on file for inspection.
• Do not route changes involving safety issues through inventory depletion; assess a field action directly.
• Link the field action SOP with the vigilance submission SOP, with unified time points and a single responsible person.
• Notify the customs and logistics teams on the launch day and freeze the related import declarations.
• State the launch right, cost bearing and the scope of information disclosure in the manufacturer’s letter of authorization and the holder agreement.
• Establish a post-action review mechanism and feed effectiveness data back into the risk management file.
• Confirm the execution result to the holder in writing after the action ends, closing the loop on record.

5. Verification checklist

GRZAN recommends hard-coding the launch threshold into the agreement: for any event that triggers the 72-hour tier of Article 8 of RDC 67/2009, the holder has the right to launch a field action directly without the factory’s consent, with costs settled separately, keeping internal negotiation out of the statutory window. At the same time, set a response deadline for second-tier distributors; treat non-responses as unconfirmed and escalate directly to end-user institutions one by one.

• □ Confirm the parties responsible for execution and notification are the Brazilian registration holder
• □ Verify whether the reporting clock of Article 8 of RDC 67/2009 has been triggered in parallel
• □ Verify the completeness of the distribution and use chain list
• □ Verify the archiving of execution receipts and effectiveness verification data
• □ Verify that the launch of the field action froze the related import declarations in parallel
• □ Verify the agreement clauses on the launch right and cost bearing
• □ Verify that the post-action review has been fed back into the risk management file
• □ Verify the current text of RDC 551/2021 against in.gov.br

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN provides end-to-end post-market compliance support for the Brazilian market: technovigilance submissions, field action planning and execution, recall coordination, inventory depletion evidence chains and ANVISA inspection response. From launch-threshold drafting to recovery-rate verification, our team helps holders and foreign manufacturers close every loop on record. For support with vigilance, recalls and inspections in Brazil, contact info@grzanglobal.com.