Brazil IN 290/2024: Optimized Review for Devices Approved by Recognized Authorities

1. Key takeaways

IN 290/2024, effective June 3, 2024 and issued on the basis of RDC 741/2022, opens an optimized review pathway (procedimento otimizado) for first-time registration applications of Class III and Class IV devices that have already been approved by an equivalent foreign regulatory authority (AREE/EFRA). GRZAN’s judgment: the value of this pathway is not that it moves faster, but that it converts foreign compliance assets directly into Brazilian time. However, it carries 2 hard thresholds — only first-time Class III/IV applications qualify, and devices approved through simplified procedures are excluded; hitting either one sends you back to regular review. One point must be stated first: Article 10 provides that optimized review does not change the queue position of the application. What is saved is duplicated review content, not the place in line.

2. Legal basis

• Optimized review procedure (regulatory reliance) — IN nº 290/2024, issued April 4, 2024, effective June 3, 2024 (Article 17): Articles 1 through 6, Article 8, Article 9 (return to regular review requires a stated justification), Article 10 (optimized review does not change the queue position of the application), Article 11 (submissions not made in the prescribed secondary petition form are converted to regular review), Article 13, Article 14, Article 15 (applications already under review before the effective date may apply to convert to optimized review), Article 16 (violations constitute health offenses)
• General criteria for the acceptability of review outcomes of equivalent foreign regulatory authorities — RDC nº 741/2022, resolution of August 10, 2022: Article 1, Article 2, Articles 3 through 5
• Requirements for the classification, notification and registration of medical devices and for labeling and instructions for use — RDC nº 751/2022, resolution of September 15, 2022: Article 5, Article 7, Article 11

3. Expert insights

GRZAN breaks the entry conditions of IN 290/2024 into 4 gates; all are indispensable, and screening should proceed from the coarsest filter to the finest.

Gate one is scope (Article 2): only first-time registration applications for Class III and Class IV devices qualify, and in vitro diagnostic devices (IVDs) are expressly included. Renewals, changes, and Class I/II notifications cannot enter this channel; the first-application limit is hard.

There is also an upstream logic: Article 1 of IN 290/2024 states that it is established under RDC 741/2022, which sets the general criteria for the acceptability of EFRA review outcomes (Article 1 general provisions, Article 2 definitions, Articles 3 to 5 acceptability and ongoing assessment). Optimized review is therefore not an independent new policy but an implementing procedure inside the regulatory-reliance framework.

Gate two is approval (Article 3): prior approval by an AREE is the premise. Article 6 fixes the recognized list at 4 authorities and their evidence forms — Australia’s TGA, Canada’s Health Canada, the US FDA (510(k), PMA, De Novo), and Japan’s MHLW. The European Union is not on the list; a CE certificate cannot be exchanged directly for optimized review. GRZAN cautions: what is being matched is not merely whether a certificate exists, but whether the evidence form matches the specific type enumerated in Article 6.

At the submission level, the application must be accompanied by an electronic-signature eligibility declaration, the EFRA approval documents, and the EFRA’s current IFU (these details were identified through supplementary verification; defer to ANVISA publications). The preparation time for these three items is routinely underestimated.

Gate three is exclusion (Article 4): devices approved by an EFRA through a simplified procedure do not qualify for optimized review and must go through regular review. Which procedures count as simplified must be confirmed against the Portuguese text of IN 290/2024, not inferred from secondary materials — since Article 6 lists 510(k) as an FDA evidence form while Article 4 excludes simplified procedures, the junction can only be resolved from the original text (a practical estimate; defer to ANVISA publications).

Gate four is substantial equivalence. Article 5 provides the definition and Article 8 requires the Brazilian device and the foreign-approved device to match in qualitative and quantitative composition, physicochemical, mechanical, electrical, and biological characteristics, indications and intended use, manufacturer, manufacturing process, and safety and performance study results. This is not a formal declaration but an item-by-item comparison across 6 element categories, and GRZAN recommends submitting it as a formal document within the dossier.

Beyond the four gates, one point deserves separate emphasis: Article 10 states that optimized review does not change the queue position. Secondary materials almost uniformly portray regulatory reliance as acceleration or queue-jumping, while the official text says the opposite — what ANVISA skips is the technical review content already performed once by the AREE, not the application’s place in the queue. The benefit lies in fewer deficiency rounds, not in earlier certification.

The final judgment: ANVISA retains final decision-making authority, and the exits are more numerous than expected. Article 9 allows the application to be returned to regular review with a stated justification; Article 11 converts applications not submitted in the prescribed secondary petition form directly to regular review; Article 13 declares that decision-making autonomy is not waived; Article 14 stresses that optimized review does not exempt the CBPF, Portuguese labeling and IFU, import prerequisites, or other statutory requirements. The reverse convenience sits in Article 15 — applications already under review before the effective date may apply to convert — while Article 16 characterizes violations as health offenses. Companies should not write optimized review into delivery commitments to customers.

4. Practical recommendations

First, run the exclusion gate self-check early. Step 1 is to verify whether the foreign approval came from a simplified procedure; if Article 4 is triggered, schedule the project directly for regular review.

Second, align evidence forms item by item. Build a comparison table between the foreign certificate’s number and approval form and the forms enumerated in Article 6, and keep originals on file.

Third, protect first-application eligibility. The optimized pathway is limited to first applications, so the product portfolio should put qualifying products in the first batch.

Fourth, do not let the optimized pathway replace CBPF planning. The CBPF remains a precondition of approval; optimized review affects only the review method. After approval, the validity remains 10 years, counted from the DOU publication date.

Fifth, do not schedule on a queue-jumping assumption. Article 10 makes clear the queue position is unchanged; schedule gains can only be discounted through fewer deficiency rounds. Applications under review before the effective date may request conversion under Article 15.

5. Verification checklist

• □ The product is Class III or IV (IVDs included)
• □ This application is a first-time registration in Brazil, not a renewal or a change
• □ AREE/EFRA approval has been obtained, and it is not a simplified-procedure approval
• □ The evidence form of the foreign approval aligns item by item with the forms enumerated in Article 6 of IN 290/2024
• □ The substantially-equivalent comparison across the 6 element categories has been completed per Articles 5 and 8
• □ The submission was made in the secondary petition form prescribed by Article 11, avoiding conversion to regular review on formal grounds
• □ Project scheduling follows Article 10 on unchanged queue position, with no earlier certification assumed
• □ It is confirmed that ANVISA retains final decision-making authority and optimized review appears in no external delivery commitment

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Affairs Team

GRZAN provides ANVISA registration pathway and classification strategy support for the Brazilian market, including eligibility screening for optimized review under IN 290/2024, evidence-form mapping against the recognized AREE list, and integrated planning with CBPF and Portuguese documentation so that regulatory reliance delivers its real benefit: fewer deficiency rounds. To assess whether your portfolio qualifies, contact the GRZAN regulatory team at info@grzanglobal.com.