Brazil 120-Day Inventory Depletion Window under RDC 751/2022

1. Key takeaways

After a change is approved, packaging, labeling and instructions-for-use stock may be depleted within 120 days, and finished products may be sold until the end of their lifetime — but changes involving safety or performance issues do not qualify for this window. GRZAN summarizes Articles 25 and 26 of RDC 751/2022 as two release rules and one exclusion. The first step in deciding whether the window applies is not counting stock; it is determining whether the change touches safety.

2. Legal basis

• Classification, notification and registration of medical devices, and labeling and instructions-for-use requirements — RDC nº 751/2022, resolution of September 15, 2022, Articles 16, 21, 22, 25 and 26
• Technovigilance Regulation — RDC nº 67/2009, published on December 21, 2009 (DOU 2009-12-23), Article 8
• Execution and notification of field actions — RDC nº 551/2021, published on August 30, 2021 (DOU), full text

3. Expert insights

The first boundary concerns the object. Articles 25 and 26 distinguish two classes of items: finished products may be sold until the end of their lifetime, while packaging materials, labels and instructions-for-use stock have only a 120-day depletion window. GRZAN’s reading is that the legislator accepts finished products continuing to circulate but requires the carriers of the new information — labels and instructions for use — to be replaced promptly, so a limited buffer is given to packaging materials rather than an indefinite one.

The second boundary concerns the time point. Article 16 divides changes into three classes: changes requiring approval (aprovação requerida), changes with immediate implementation (implementação imediata), and changes that need no notification. Changes requiring approval take effect only after publication in the DOU under Article 21; changes with immediate implementation are published within 30 days of completed submission under Article 22. The 120-day count must be anchored to the day the change actually takes effect, not the day it was submitted — this is where production planning and inventory logs most easily drift out of alignment.

The third boundary is the exclusion. Changes involving safety or performance issues do not qualify for inventory depletion; from that point the rhythm is set by the 72 hours of Article 8 of RDC 67/2009 and the field action obligations of RDC 551/2021, not by the 120 days. GRZAN recommends making this determination at the change initiation stage and recording it, using the conclusion as the fork for all subsequent path decisions.

One point is easy to get wrong. Article 22 of RDC 751/2022 originally set a deadline of 30 days for uploading documents after changes with immediate implementation; that deadline has been deleted by RDC 777/2023. [Verification level: the amendment was confirmed through the Brazilian government’s WTO TBT notification; the article-by-article content is second-hand, and the final text must be checked against the DOU.] GRZAN adjusts its practice accordingly: the effectiveness of an immediately implemented change can no longer be inferred from a fixed node; rely instead on the completed submission record and ANVISA’s actual confirmation, and record every confirmation action in the change management system.

Another common confusion deserves its own paragraph: finished products may be sold until the end of their lifetime refers to finished products already lawfully on the market. If the labels and instructions for use attached to those products have expired because of the change, the products cannot keep circulating old versions by invoking the sale-until-lifetime rule. The two rules apply separately and cannot be cited for each other’s benefit.

The fourth boundary is the timing gap between import and repackaging. After a change takes effect, old packaging still awaiting shipment abroad will, if shipped onward to Brazil within the 120-day window, risk meeting customs clearance with goods that do not match the published content. GRZAN recommends using the change effective date as the dividing line and making a separate disposition determination for goods in transit.

The fifth boundary is records. Articles 25 and 26 provide grounds for release, not exemption from proof. GRZAN recommends archiving the inventory log, the depletion progress and the records of any remaining destruction, forming a complete evidence chain from the effective date to the zero-stock date that can be shown directly during an inspection.

4. Practical recommendations

• Complete the safety/performance determination at change initiation and file the conclusion.
• Build a packaging materials inventory log, starting the 120-day countdown from the change effective date.
• Establish an internal effectiveness confirmation mechanism for immediately implemented changes as well, not relying on the publication rhythm.
• Assess a field action directly for safety-related changes; do not use inventory depletion.
• Link with import planning so old packaging is not still clearing customs after the new rules take effect.
• Use the change effective date as the dividing line and make a separate disposition determination for goods in transit.
• Archive the inventory log, depletion progress and remaining destruction records together as one evidence chain.
• Write the 120-day window into the expiry reminders of the change management system.
• Run a remaining-stock inventory check one week before the depletion period ends and keep it on file.

5. Verification checklist

GRZAN recommends structuring the depletion decision as a three-signature process: the regulatory layer confirms whether the change touches safety; the supply chain layer reports stock and in-transit quantities; the quality layer confirms that continued circulation of old versions will not create a mismatch between label content and the physical product. Only the three signatures together can support the depletion action being accepted at inspection; no single layer is sufficient on its own.

• □ Verify the change classification (Article 16 of RDC 751/2022)
• □ Verify the effective time point (Article 21 for changes requiring approval / Article 22 for immediate implementation)
• □ Verify the start and end dates of the 120-day countdown
• □ Verify whether the safety/performance exclusion is triggered
• □ Verify the consistency of goods in transit with the published content
• □ Verify that the depletion evidence chain covers the period from the effective date to the zero-stock date
• □ Verify that the expiry reminder in the change management system is active
• □ Verify the current text of Articles 25 and 26 of RDC 751/2022 against the DOU

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN supports manufacturers through every post-market transition in Brazil: change classification under RDC 751/2022, depletion-window management for packaging and labeling stock, field actions for safety-related changes, and the documentation chains ANVISA inspectors expect to see. From the effective date to the zero-stock date, we keep your inventory decisions defensible. For post-market change and recall support in the Brazilian market, contact info@grzanglobal.com.