No import before DOU publication under RDC 751/2022

1. Key takeaways

Before publication in the DOU, a medical device may not be industrialized, imported, displayed for sale or delivered to consumption — the hard prohibition of RDC 751/2022, Article 60, §1. The only arguable space is stock consumption in change situations: packaging, labels and instructions for use may be used up within 120 days, and the exception does not apply to a first import. GRZAN calls this the first red line of a Brazilian project, and its consequences fall simultaneously on the goods and on the entity.

2. Legal basis

• Classification, Notification and Registration of Medical Devices and the Requirements for Labels and Instructions for Use — RDC No. 751/2022, resolution of September 15, 2022, in force as of March 1, 2023; Article 10, §2 (the review must be completed within the periods set by Brazilian health legislation), Article 11, Article 25, Article 26, Article 29 (a product no longer commercialized in Brazil requires a cancellation application), Article 44 (cancellation must be published in the DOU), Article 47 and Article 60, §1
• Technical Regulation on Health Surveillance of Imported Goods — RDC No. 81/2008, published on November 5, 2008; import requires the prior express consent of the health authority
• 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 as of that date (Article 26); Article 7 (products must first be registered with ANVISA), Article 7, §1 (the registration review deadline is 90 days, counted from the date of filing), Article 10 (import requires a prior position from ANVISA), Article 23 (advance notice of cessation of production or import, expressly limited in the text to registered medicines, not applicable to devices), Article 24 (violation of this decree constitutes a health infraction, with civil and administrative liability under Lei No. 6.437/1977), Article 25 (revocation of Decreto No. 79.094/1977 and Decreto No. 3.961/2001)
• Basic Law on Health Surveillance of Health Products in Brazil — Lei No. 6.360/1976, dated September 23, 1976, published in the DOU on September 24, 1976 (Seção 1, p.12647); Article 12, §3 (as rewritten by Lei No. 13.411/2016: the registration must be issued within 90 days of filing, except Articles 17-A, 21 and 24-A — all three exceptions are medicine-specific procedures, so the 90 days still applies to devices), Article 12, §4 (registration and revalidation acts produce effect only from the date of publication in the DOU)
• Law on Health Infractions and Penalties — Lei No. 6.437/1977, dated August 20, 1977, published in the DOU on August 24, 1977 (Part 1, p.11145); in full (the statutory source of the list of penalties)

3. Expert insights

The GRZAN view: this red line is most often breached by goods already at port. The market authorization is valid for 10 years counted from the DOU publication date, so the right only comes into existence at publication; goods arriving earlier are, in law, an unauthorized import. Decreto 8.077/2013, Article 10, likewise requires a prior position for import, echoing Article 60, §1, from the level below. DOU publication operates on two layers: Article 60, §1, at the regulation level, and Lei 6.360/1976, Article 12, §4, at the statute level — effect arises only from publication, so pre-publication actions have no legal footing.

The second point: the stock consumption exception is frequently misapplied. Articles 25 and 26 give the consumption window after a change has been approved for an already registered product — finished goods may be sold until the end of their life, and packaging, labels and instructions for use may be consumed within 120 days, with no window for changes involving safety or performance. It does not apply to a first import that was never approved; the two situations cannot be mixed.

Third, the statutory source of the consequences is Lei 6.437/1977, whose penalties include fines, seizure, destruction, prohibition of sale and suspension of commercialization; treating port-arrived goods as approved product pushes the risk down the entire channel.

The fourth point concerns labeling. Article 47 requires the label to state the registration number, which only exists after DOU publication; label finalization must therefore follow publication, and labels printed in advance can only be scrapped.

The fifth point concerns review timelines. RDC 751/2022 does not set its own review period for devices; Article 10, §2, refers to the periods set by Brazilian health legislation — a cross-reference that must be resolved on two levels. At the statute level it is the 90 days of Lei 6.360/1976, Article 12, §3 (as rewritten by Lei No. 13.411/2016), and at the decree level the 90 days of Decreto 8.077/2013, Article 7, §1, both counted from the date of filing. The 90 days is a procedural ceiling, not a promise of approval; the actual timeline depends on dossier completeness and deficiency rounds. The hierarchy must also be read carefully: the device validity is 10 years (RDC 751/2022, Article 11), not the 5 years of the parent law; the renewal application window is likewise a maximum of 12 months and a minimum of 6 months before expiry, with its source in RDC 250/2004, Article 1 (as rewritten by RDC 212/2018), introduced for device renewal by RDC 751/2022, Article 27, §2 — numerically identical to Decreto 8.077/2013, Article 8, §2, but with a different legal source; this is the most common miscitation. Where no decision issues by expiry, the registration renews automatically; but automatic renewal does not halt the review — ANVISA may still reject and cancel an automatically renewed registration — and failure to apply within the window causes the registration to lapse (caducidade). Automatic renewal protects against a gap in validity, not against an adverse outcome. The window applies only to Class III/IV registro; Class I and II are notification products, exempt from revalidation under Article 28.

Because the decree in principle applies to devices, any claim of non-application must be confined to specific provisions: devices are correlato under Brazilian law (Lei 6.360/1976, Article 1, pointing to Lei No. 5.991/1973, Article 4, item IV), so Articles 2, 10 and 24 can in principle all be applied to devices.

The sixth point concerns the exit side, and it corrects a common miscitation first: the advance notice of 6 months, extendable to 12 months, in Decreto 8.077/2013, Article 23, is expressly limited in its text to registered medicines (medicamento registrado) and cannot be applied to medical devices. Device exit follows RDC 751/2022, Article 29 — a product no longer commercialized in Brazil requires the holder to apply for cancellation; the cancellation must also be published in the DOU (Article 44); the route is the application plus the DOU publication. GRZAN reads this against Article 60, §1: exit is not achieved by simply stopping orders, and stopping supply without applying for cancellation falls, through Article 24, into the liability channel of Lei 6.437/1977.

4. Practical recommendations

GRZAN recommends fixing the DOU publication date as a hard milestone in the project plan: shipping, booking and customs clearance all scheduled after that date, with the party bearing demurrage costs agreed in the trade contract. Where early shipment is genuinely necessary, obtain a written compliance opinion and make explicit that the goods may not be released before publication.

For changes to already registered products, take stock before filing and estimate the consumption speed of packaging materials against the 120 days; the count must cover goods in transit as well as in the warehouse, because counting only warehouse quantities understates the stock. Changes involving safety or performance do not benefit from the consumption window and should move directly to the new labeling.

Tag batches with a compliance status in the warehouse management system: only published products may leave the warehouse; the tagging should also cover samples and display items, which count as display for sale just the same. Archive the first release of a newly launched product together with a screenshot of the DOU publication.

5. Verification checklist

• □ Has the registration or notification been published in the DOU, and is every import batch dated after the publication date
• □ Is the stock consumption a change situation free of safety or performance issues
• □ Does the label state a valid registration number
• □ Have models withdrawn from commercialization had cancellation applications filed under RDC 751/2022, Article 29

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN supports manufacturers entering the Brazilian market across the full holder and import chain: holder-structure design, AFE and operating authorization planning, importer qualification, vigilance readiness and official fee budgeting. For tailored support on Brazilian license holders, import qualifications and fee budgets, contact info@grzanglobal.com.