Brazilian import clearance: prior consent and DUIMP migration

1. Key takeaways

Importing medical devices into Brazil requires the prior express consent of ANVISA, and this statutory requirement has not changed; what changes is the filing channel, which is migrating from LI/LPCO to DUIMP, with medical devices falling in the December 2024 batch. GRZAN’s advice is to hold firmly to the statutory requirement while refusing to hard-code the specific migration dates, because once a date shifts, an entire import plan built on it has to be rebuilt from the ground up.

2. Legal basis

• 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 [in force; ANVISA opened the revision procedure for this regulation in May 2024, and it is included in the 2025 regulatory agenda]
• 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 29 (a product no longer commercialized requires a cancellation application), Article 47 and Article 60, §1
• Procedures for charging the fee for health surveillance of goods — RDC No. 857/2024, published on May 9, 2024, in force as of June 3, 2024; rules on payment and payment slips [practical estimate, subject to what ANVISA publishes]
• 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 10 (import requires a prior position from ANVISA), Article 10, §2 (personal use without resale needs no authorization), Article 23 (advance notice of cessation of production or import, expressly limited in the text to registered medicines), 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)

3. Expert insights

The GRZAN view: separating the statutory requirement from the operational process is the most useful method for understanding Brazilian imports. Prior consent comes from RDC 81/2008 and Lei 6.360/1976, Article 10, and it is stable over the long term; the migration from LI/LPCO to DUIMP, and the integration of the health surveillance fee payment into the foreign trade single window, belong to an operational layer that can change at any time. The former can be written into contracts; the latter should only be written down as a verification path.

The second point: do not rely on mandatory switchover dates circulating through second-hand channels. GRZAN could not verify a specific date from official ANVISA sources, and therefore states only the verifiable position that the rollout proceeds in batches by category, with medical devices from December 2024, and recommends clients defer to the official announcement current at the time of filing. The cost of hard-coding a date is a wasted plan and damaged trust inside the team.

Third, the most fragile element during the switchover is data consistency. The product information in the declaration must match the registration certificate, the UDI-DI and the scope of activities in the operating authorization; any mismatch in any one of them will be intercepted by the system, and because the interception happens at customs clearance, the cost of correcting it far exceeds the cost of checking in advance.

The fourth point concerns the division of responsibility. Whatever happens to the channel, the importer remains the declaring party. Handing customs declarations entirely to the forwarder without internal review amounts to outsourcing the compliance judgment to the party least familiar with the product, and the consequences of that arrangement surface at the worst possible moment.

The fifth point concerns the revision itself. The regulation is in the middle of a revision process whose direction is one general resolution plus several sectoral normative instructions. For importers this means that clause numbers and filing requirements may both change, so internal work instructions should carry version numbers and verification dates rather than being followed as a permanent, unversioned text.

The sixth point first settles a question of scope: medical devices are correlato under Brazilian law (Lei 6.360/1976, Article 1, brings correlatos into scope and points to Lei No. 5.991/1973, whose Article 4, item IV, defines correlato as instruments and accessories for diagnostic analysis, optical, medical acoustics and dental use). Decreto 8.077/2013 therefore applies to devices in principle, and Articles 2, 10 and 24 can all be used for devices; only provisions expressly written for medicamento, such as Article 23, do not apply. GRZAN’s reminder is that non-application must be limited to the specific clause and never extended to the whole decree.

The seventh point concerns the boundary of the exemption. Decreto 8.077/2013, Article 10, §2, provides that personal use without resale needs no ANVISA authorization. GRZAN considers this exemption far narrower than it looks: it addresses natural persons importing for their own use, and commercial imports never fall inside it, whatever the quantity and whether or not payment is involved. Samples, display items and donated goods are the most frequent misjudgments here: once they enter a commercial channel or are used for promotion, the full registration and prior-consent path applies again.

The eighth point concerns the exit side, correcting a common miscitation first: the advance notice of 6 months, extendable to 12 months, in Decreto 8.077/2013, Article 23, is limited in its text to registered medicines, and devices cannot borrow it; where a device is no longer commercialized in Brazil, RDC 751/2022, Article 29, requires the holder to apply for cancellation. In GRZAN’s cases involving supplier changes, terminated agency relationships or exits from the Brazilian market, the same problem recurs: the commercial terms are negotiated, but nobody claims the cancellation and wind-down. Missing that step converts a business decision directly into a health infraction under Lei 6.437/1977 through Article 24.

4. Practical recommendations

Run a document reconciliation before the first import: registration number, product model, UDI-DI, the scope of activities in the importer’s operating authorization, and the payment receipt. Clear customs only after the five are aligned, and keep the reconciliation record. The exercise should also include the Portuguese product name and the exact model spelling, because the declaration system matches names more strictly than companies expect.

Leave a buffer for clearance: prior-consent review and health inspection may involve sampling, so build time into the trade terms and the warehousing arrangement to keep demurrage from eating the margin. The buffer should be set for the least favorable case, not the average, because the variance in clearance comes from inspection rather than from the process itself.

Fix one official verification step: at the start of every project, confirm the currently applicable filing channel and payment method on ANVISA’s official import page, and archive a screenshot. The verification should be done in-house, not borrowed from second-hand summaries. It costs little time and prevents an entire consignment from being sent down the wrong channel.

5. Verification checklist

• □ Does the importer’s operating authorization include the import activity and remain in good standing
• □ Is the product registered or notified and published in the DOU
• □ Do the declaration data match the registration certificate and the UDI-DI
• □ Has the health surveillance fee been paid as required with the receipt retained
• □ Has the currently applicable filing channel been confirmed with ANVISA officially
• □ Are samples, display items and donated goods excluded from the personal-use exemption
• □ Have models withdrawn from import or delisted 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.