Brazil Premarket Pathway Decision Tree: Five Steps from Classification to Dossier

1. Key takeaways

A Brazilian premarket plan can be locked down in 5 steps: set the risk classification, set the notification or registration pathway, set whether the CBPF is mandatory, set the language tiering, and set the documentation package with the optional optimized review. GRZAN’s judgment: of these 5 steps, only step 3 truly changes the project schedule — for Class III (high-risk) and Class IV (maximum-risk) devices, the CBPF is a precondition of approval. The other four steps determine the scope of documentation and the workload; the CBPF determines the length of the critical path.

2. Legal basis

• 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 6, Article 7, Article 10(9), Article 10(10), Article 14(V)
• Granting and renewal of the CBPF — RDC nº 687/2022, effective June 1, 2022: Article 3
• Optimized review procedure (regulatory reliance) — IN nº 290/2024, issued April 4, 2024, effective June 3, 2024: Article 2, Article 3, Article 4, Article 6

3. Expert insights

GRZAN designs this decision tree as a sequence of judgments rather than a parallel checklist, for a practical reason: the conclusion of each step cuts away part of the options that follow, and skipping the order generates large amounts of wasted work.

Step 1 sets the classification. Under Article 5 of RDC 751/2022, the device is placed into Class I (low-risk), Class II (medium-risk), Class III (high-risk), or Class IV (maximum-risk). The most common error at this step is transposing a foreign classification directly; GRZAN recommends re-determining the class under the Brazilian rules and keeping a written record.

Step 2 sets the pathway. Classes I/II go through notification (notificação) and Classes III/IV through registration (registro); in vitro diagnostic devices are separately governed by RDC 830/2023. The processing limit for notification is 30 days, and notification products are non-transferable — they can only be filed again — which in turn affects the choice of license-holding structure.

Step 3 sets the CBPF. Article 3 of RDC 687/2022 confines the mandatory scope to Class III/IV production units, while Article 14(V) of RDC 751/2022 and its paragraphs 2 and 3 allow an acceptance receipt as an interim, with approval still conditional on the CBPF being published in the DOU. If the company already holds MDSAP, then under Article 8 of RDC 497/2021 as amended by RDC 850/2024 the certificate can be valid for 4 years, on the condition of remaining continuously within the MDSAP system.

Step 4 sets the language. The application form, the instructions for use, and the label mock-ups must be in Portuguese, while the remaining documents may be in Portuguese, Spanish, or English — 3 acceptable languages in total — so the archive can be organized by source-document language when planning translation.

Step 5 sets the documentation package and the optimized route. First-time Class III/IV applications can assess optimized review under IN 290/2024, but two gates come first: the foreign authority has approved the device, and the approval is not from a simplified procedure. The registration is valid for 10 years, counted from the DOU publication date.

Across multiple projects, GRZAN has verified one conclusion: the step most often gotten wrong is step 1. Once the classification is set too low, the remaining four steps all stand on a false premise — the company prepares notification-grade documentation while the product actually requires registration, and what must be redone is not only the documents but also the commercial schedule already set in motion. Classification decisions must therefore be recorded and revisited whenever the product portfolio expands.

The same discipline applies to step 3, but in the opposite direction: it is less often set too low than simply deferred. Because the acceptance receipt makes submission possible without a published CBPF, teams are tempted to treat the certificate as a later problem, and then discover at approval time that the critical path runs through an audit cycle they never scheduled. The decision tree exists precisely to force this confrontation early: a CBPF marked as mandatory on the tree is a signed commitment to a start date, not a box to be ticked later.

4. Practical recommendations

First, output the decision tree as one table. The GRZAN regulatory team recommends one row per product and five columns matching the five step conclusions, as the baseline document for project initiation.

Second, prioritize resources for the CBPF. Whenever the class is determined as III/IV, BGMP conformity preparation should start together with technical documentation drafting, and it should be tracked separately as the critical-path item of the project.

Third, front-load the language work. Do not leave Portuguese finalization until just before submission, especially for SaMD interface and message text.

Fourth, treat the optimized route as an accelerator, not a dependency. If the IN 290/2024 conditions are met, pursue them; if not, schedule for the regular route, and in neither case delay CBPF and documentation preparation.

Fifth, use the decision tree at the project kickoff, not before submission. The GRZAN regulatory team recommends completing the table at the kickoff meeting so that R&D, regulatory, and commercial teams align on the same conclusions instead of advancing on different assumptions.

5. Verification checklist

• □ Step 1: risk classification determined under Article 5 of RDC 751/2022 and recorded in writing
• □ Step 2: pathway set as notification or registration, with IVDs confirmed under RDC 830/2023
• □ Step 3: CBPF mandatory status determined; mandatory items initiated and the optional MDSAP route assessed
• □ Step 4: the mandatory Portuguese scope defined and the languages of remaining documents chosen
• □ Step 5: optimized-review applicability checked gate by gate against Articles 2, 3, 4, and 6 of IN 290/2024
• □ Decision-tree conclusions aligned at the kickoff meeting with R&D, regulatory, and commercial teams

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Affairs Team

GRZAN supports manufacturers entering the Brazilian market with ANVISA registration pathway and classification strategy services, including five-step premarket planning, CBPF critical-path management, and language and documentation strategies under RDC 751/2022 and IN 290/2024. To turn this decision tree into a project baseline for your own portfolio, contact the GRZAN regulatory team at info@grzanglobal.com.