Brazil 2026 Regulatory Agenda: Three Levers for Compliance

1. Key takeaways

For 2026 medical device compliance priorities in Brazil, GRZAN gives an explicit ranking: UDI data implementation first (IN 426/2026, effective 2026-03-01), the ESPR version change second (RDC 848/2024, effective 180 days after publication), and the AREE plus MDSAP reliance route third (IN 290/2024, effective 2024-06-03). The ranking follows urgency: the first two have already entered their mandatory periods, while the third is an accelerator that can compress timelines.

2. Legal basis

• Transmission and management of the UDI database SIUD — IN nº 426/2026, published in the DOU on February 18, 2026, effective March 1, 2026 (Article 16), Articles 3, 10, 11 and 15
• Essential safety and performance requirements — RDC nº 848/2024, resolution of March 6, 2024, published in the DOU on March 8, 2024, effective 180 days after publication (Article 88), effectiveness announcement issued by ANVISA on September 10, 2024, Articles 85, 86 and 15–19
• Optimized review under AREE — IN nº 290/2024, issued April 4, 2024, effective June 3, 2024, Articles 1 through 6
• CBPF procedures and the MDSAP route — RDC nº 850/2024, resolution of March 20, 2024, in force April 1, 2024 (Article 2), amending Article 8 of RDC 497/2021

3. Expert insights

Lever one is UDI data implementation. Article 3 of IN 426/2026 moves the transmission point forward to before market placement, Article 10 allows authorizing a third party to transmit while responsibility is not transferred, Article 11 ties back to the class schedule of Article 15 of RDC 591/2021, and Article 15 qualifies non-compliance as a health offense under Lei 6.437/1977. GRZAN’s judgment: this is the only obligation of 2026 already counting down, with Class IV feeling the pressure first.

Lever two is the ESPR version change. Article 86 of RDC 848/2024 repeals RDC 546/2021 and merges devices and IVDs into one set of principles; Articles 15–19 and Articles 50, 51 and 53 form the verifiable hard requirements. GRZAN’s judgment: this is retrofit work on the installed base, covering every registered and in-review product, with workload proportional to the number of products.

Lever three is the AREE and MDSAP reliance route. Article 2 of IN 290/2024 limits application to first marketing authorization submissions for Classes III and IV (including IVD), Article 3 presupposes approval by an equivalent foreign regulatory authority, and Article 4 excludes products approved through simplified procedures; RDC 850/2024 sets the validity of a CBPF granted through MDSAP at 4 years, conditioned on staying continuously within MDSAP. GRZAN’s judgment: this is the only lever that directly compresses time, and its gate is the quality of the foreign approval evidence.

GRZAN also flags a sequencing issue that is easily overlooked: the three levers are not independent of each other. UDI data implementation depends on the settled determination of product models and UDI-DIs, the ESPR version change depends on updating the technical documentation system, and AREE optimized review depends on foreign approval evidence — all three share the same product master data. If the master data is inconsistent, the three workstreams will reach different conclusions and rework costs run high.

One boundary case is worth putting on the annual agenda: in 2025 ANVISA approved reclassifying sodium chloride solutions for nasal irrigation (the 0.9% solution and powder form) as Class IV medical devices (applying classification rule 14), with a transition period running to 2026-05-30; products still notified as drugs after that date will be cancelled automatically. [The RDC number has not been officially confirmed and is not given here; verification level: compiled from consistent industry and official notices, subject to ANVISA publication.] GRZAN’s judgment: this case shows that Brazilian classification conclusions can change and that expired drug notifications are cancelled automatically — a company cannot rely on the way it was approved back then as a long-term basis, nor treat a non-device route as a way to avoid registration.

On return on effort, GRZAN’s judgment is that the third lever offers the highest marginal benefit but the hardest entry conditions: Article 2 of IN 290/2024 limits it to first marketing authorization submissions for Classes III and IV, and Article 4 excludes products approved through simplified procedures. Companies that meet the conditions should pursue it first; companies that do not should not spend excessive time here and should invest resources in the first two levers.

4. Practical recommendations

GRZAN recommends splitting 2026 into quarters: complete UDI data and SIUD process setup in the first quarter, complete the ESPR cross-reference table change in the second quarter, assess AREE and MDSAP availability in the third quarter, and run the annual review and next-year scheduling in the fourth quarter. This split lets the three levers be handled in concentrated windows instead of leaving resources scattered all year.

• Set the annual order: UDI data implementation (urgent) → ESPR version change (retrofit) → AREE/MDSAP (accelerator).
• UDI: set up the SIUD account and transmission process first, Class IV first, with the label carriage plan prepared in parallel.
• ESPR: rebuild the cross-reference table, adding evidence separately for SaMD and IVD.
• AREE: confirm first whether the foreign approval was a non-simplified procedure before applying for optimized review.
• MDSAP: maintain audit status — the precondition for keeping the 4-year CBPF validity.
• Schedule two regulatory review points during the year, verifying deadlines and texts against the DOU and AnvisaLegis.
• Unify product master data as the shared foundation of all three levers.
• Companies meeting the conditions should apply for AREE optimized review first; others should move to conventional-path scheduling.
• Review the progress and ranking of the three levers once a quarter.

GRZAN further recommends raising the review frequency to weekly: at a fixed time each week, search the DOU and AnvisaLegis, register new and amended texts in the regulatory log, with entries covering at least the number, publication date, effective date and affected product list. Also set one failure signal for each lever — on the UDI side, a failed transmission or an overdue correction; on the ESPR side, unmapped provisions remaining in the cross-reference table; on the AREE side, incomplete foreign approval evidence or a simplified-procedure approval. Once any signal triggers, return to the annual plan and reschedule rather than carrying over the previous timetable.

5. Verification checklist

• □ Verify the IN 426/2026 effective date 2026-03-01 and the class transmission deadlines
• □ Verify that the RDC 848/2024 cross-reference table has completed the version change
• □ Verify whether the product is Class III/IV and whether an EFRA approval exists (Articles 2 and 3 of IN 290/2024)
• □ Verify whether the foreign approval went through a simplified procedure (excluded by Article 4)
• □ Verify MDSAP status and the conditions for maintaining the 4-year CBPF validity (RDC 850/2024)
• □ Verify master data consistency across the UDI, ESPR and AREE workstreams
• □ Verify the completeness of the foreign approval evidence in the AREE submission file
• □ Verify whether products notified in Brazil on a non-device route have been reclassified
• □ Set one regulatory review point in each half of the year

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN builds annual regulatory plans for the Brazilian market around the three levers of 2026: UDI data implementation, ESPR version changes and AREE/MDSAP reliance routes, backed by weekly DOU monitoring and a single set of product master data. We turn a crowded agenda into a sequenced, verifiable plan your team can actually execute. For regulatory planning and post-market compliance support in the Brazilian market, contact info@grzanglobal.com.