Brazil Family, System and Kit Grouping under IN 320/2024

1. Key takeaways

The direct legal basis for combined filings in Brazil is not a standalone grouping regulation but the sole paragraph of Article 3 of RDC 751/2022: ANVISA also grants notification or registration to 3 types of unit — family (família), system (sistema), and kit (conjunto/kit) — with the specific grouping rules set by a dedicated normative instruction, currently IN nº 320/2024. GRZAN’s judgment: grouping compresses the number of registration numbers, not the burden of proving technical differences. The more models inside a group, the more the technical dossier must explain, item by item, why each difference does not constitute a new risk.

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 (Board meeting of September 14), published in DOU No. 180 of September 21, 2022 (Seção 1, p.172), effective March 1, 2023 (Article 67): Article 3 sole paragraph, Article 4(XX), Article 4(XXVI), Article 5, Article 6, Article 7, Article 14(V)
• Grouping rules for families, systems and kits — IN nº 320/2024 (its purpose was confirmed on ANVISA’s official device page; the full text was not obtained in this verification, and the specific grouping criteria defer to ANVISA publications)
• Amendments in force to the requirements for the classification, notification and registration of medical devices — RDC nº 777/2023, resolved and effective March 1, 2023 (its existence was confirmed through Brazil’s WTO TBT notification; article-level content is secondhand — a practical estimate; defer to ANVISA publications)
• Unique device identification requirements — RDC nº 591/2021, effective since January 2022: Article 15 (as amended by RDC nº 884/2024) (the deadline table reflects common industry compilation; defer to ANVISA publications)
• Transmission and management of UDI data in the SIUD database — IN nº 426/2026, issued February 13, 2026, published in the DOU on February 18, 2026, effective March 1, 2026 (Article 16): Article 3, Article 5, Article 11

3. Expert insights

Where is the value of the sole paragraph of Article 3? GRZAN’s reading: in Brazil, compliance costs attach to each registration number — the technical dossier, the Portuguese labeling and instructions, the TFVS cost items, and afterwards every change and every technovigilance duty follow the number. Allowing one number per family, system, or kit is essentially letting homogeneous products share a single compliance vehicle and squeezing out duplicated cost.

But the boundary of grouping is drawn by definitions, not by the applicant’s preference. Article 4(XX) defines a family as a set of products similar across 5 dimensions — indications or use, mechanism of action, technology, composition, and precautions. Article 4(XXVI) sets a harder test for kits: the components must come from the same manufacturer or the same manufacturing group, and no interdependence may exist among them. GRZAN’s conclusion: kits and systems are two different kinds of combination — a system permits components to work together, while a kit requires precisely that components be independent — and preparing documentation for both with the same mindset will inevitably go wrong.

The second judgment is that grouping does not compress identification granularity. Article 5 of IN 426/2026 requires each set of data to correspond to one unique UDI-DI and one device model, and Article 3 requires the UDI-DI to be transmitted before the device is placed on the Brazilian market, while the UDI-PI is maintained by the holder within its own quality system to preserve traceability. This runs in the same direction as the labeling deadlines set by risk class in Article 15 of RDC 591/2021: however many models the group contains, that many identification data sets must be prepared — not 1 of them can be skipped.

The third judgment is that the burden of proof is not lightened by combining. Differences among family members in indications, materials, or performance must still be argued item by item; what combination buys is administrative efficiency, not a looser review standard. Stuffing obviously cross-category models into one group costs a deficiency notice for the entire group.

The fourth judgment is that the CBPF is not reduced by grouping. The certificate requirement for Class III (high-risk) and Class IV (maximum-risk) production units still follows Article 14(V); grouping operates on the filing unit, not on the manufacturing floor.

4. Practical recommendations

First, draw the family boundary with a 5-dimension calibration table. The GRZAN regulatory team recommends filling in, per model at project initiation, the indications or use, mechanism of action, technology, composition, and precautions; any non-similar dimension means the model is split out.

Second, for kits check the entity and independence first. Confirm that all components come from the same manufacturer or manufacturing group, and state in writing that no interdependence exists among them; if it fails, file as a system or as individual products.

Third, plan identification data together with grouping. Prepare a UDI-DI per model and schedule the IN 426/2026 transmission before market placement in Brazil, not after the registration number arrives.

Fourth, count the change impact. When any model in the group triggers a change requiring approval, the documentation of the whole group may be affected; inventory drawdown and revised production scheduling should be considered together with the grouping strategy.

Fifth, complete a final verification before filing. The grouping details of IN nº 320/2024 and the article-level amendments of RDC 777/2023 were not obtained from official originals in this review; GRZAN recommends completing a final check against anvisalegis and the DOU before formal submission and filing the verification record in the project archive.

5. Verification checklist

• □ The family boundary has been calibrated model by model against the 5 dimensions of Article 4(XX)
• □ Kit components are confirmed to come from the same manufacturer or manufacturing group, with no interdependence among components
• □ The grouping conclusion is recorded in writing, and cross-dimension models have been decided for splitting
• □ UDI-DIs are prepared per model, with transmission scheduled before Brazilian market placement
• □ The CBPF requirement for Classes III/IV has not been mistaken as reducible by grouping
• □ The grouping details of IN nº 320/2024 have undergone final verification on anvisalegis or the DOU

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 family, system, and kit grouping design under RDC 751/2022 and IN 320/2024, per-model UDI planning under IN 426/2026, and grouping strategies that cut registration numbers without inflating review risk. To test whether your portfolio should be grouped or split, contact the GRZAN regulatory team at info@grzanglobal.com.