Portuguese language requirements for Brazil regulatory submissions

1. Key takeaways

Brazil’s language requirements come in two tiers: 3 categories — the application form, the instructions for use or user/operator manual, and the label model — must be in Portuguese (Art. 10 §9 of RDC 751/2022), while the remaining documents composing the application may be in any of 3 languages: Portuguese, Spanish or English (Art. 10 §10). Misjudging the tier split is the most easily rejected basic error in the entire Brazilian project, and it fails not on substance but on form, which means it is entirely preventable with a fixed two-tier list and a terminology table maintained before any translation work begins.

2. Legal basis

• Classification, Notification and Registration of Medical Devices, and Labeling and Instructions for Use Requirements — RDC No. 751/2022, decided on September 15, 2022, effective March 1, 2023 (Art. 67), Art. 10 §9, Art. 10 §10, Art. 46 item 1, Art. 47
• In Vitro Diagnostic Medical Devices — RDC No. 830/2023, published on December 11, 2023 (DOU 234), effective June 1, 2024 (Art. 71), Arts. 12, 67 and 68
• Essential Safety and Performance Requirements — RDC No. 848/2024, published in the DOU on March 8, 2024, Art. 1 §3, Art. 85

3. Expert insights

The logic of the two tiers is clear: material that faces the regulator for filing and material that faces users for reading must be Portuguese; technical evidence material may be English, to hold down translation costs for foreign manufacturers. GRZAN’s judgment is that the most misread point of the tier split sits in the user/operator manual: many companies classify it under remaining documents and file it in English, and the file is returned at formal examination. Any text that will ultimately reach Brazilian healthcare professionals or patients is processed under the first tier, without exception and regardless of how internal teams label the document internally.

The second pitfall is translation consistency and traceability. Art. 46 item 1 writes the Portuguese requirement for labels and instructions for use as a general rule, and Art. 47 then lists the mandatory items. The high-frequency problem GRZAN sees in projects: the device name in the Portuguese label differs from the name in the application form and the technical dossier, and ANVISA will treat them as different products on that basis. The remedy is to build a Portuguese terminology table first, fixing the model names, intended use statements and warning wording before any template is produced.

Third judgment: IVDs run on the RDC 830/2023 channel. The two-tier language principle matches, but IVD instructions for use additionally involve results interpretation, cut-off values and reference intervals — content that depends heavily on local expression — so the translation must be reviewed by professionals with laboratory medicine backgrounds, not merely converted linguistically. Control materials without assigned values and DNA/RNA extraction products must also complete compliance within the 365-day transition (Arts. 67 and 68).

Fourth trade-off: retaining English technical documents has real value. Art. 10 §10 allows English, which means core evidence such as risk management, clinical evaluation and performance verification does not need wholesale conversion into Portuguese; companies can concentrate the translation budget on first-tier documents and key summaries. This is the practical cost-control lever in a Brazilian project, and it is worth defending explicitly when internal budgets are cut.

Fifth judgment: the two tiers change at very different frequencies and must live in one version ledger. First-tier documents are re-issued in Portuguese at almost every label revision and instructions update, while second-tier English technical evidence may stand unchanged for years. Without a unified ledger, the situation arises where the Portuguese label is based on an outdated English technical file. GRZAN’s practice is to fix a footer on every Portuguese document citing the reference document number it was translated from, so a checker can compare directly at a glance during any review or inspection.

Sixth judgment: language decisions belong at project kickoff, not at submission week. The two-tier split is knowable from Art. 10 §§9 and 10 on day one, yet GRZAN still sees companies discover the Portuguese-only scope after the technical evidence is frozen, when re-translating templates mid-project doubles the workload and introduces exactly the terminology drift described above. Locking the tier list, the terminology table and the translator assignments in the project plan costs an afternoon and removes a whole class of formal-examination rejections; deferring it usually costs a full resubmission cycle instead. Seventh judgment: treat the Portuguese deliverables as controlled documents with owners and review gates. Because first-tier documents are regenerated frequently, each release should pass the same consistency check — model names, intended use, warnings, holder and manufacturer blocks — against the ledger before it is filed, so that language quality does not degrade silently across successive revisions.

4. Practical recommendations

• Fix the first-tier list as the application form, the instructions for use or user/operator manual, and the label model, all issued in Portuguese.
• Choose Portuguese or English uniformly for the second tier according to the company’s language capacity, avoiding mixed languages inside one dossier.
• Maintain a Portuguese terminology table standardizing model names, intended use and warning wording.
• Bind translations to their source versions, marking the source document number and version date.
• Bring both tiers into one version ledger, with the Portuguese versions footnoting the source document number.
• The marketing authorization is valid 10 years; at revalidation, re-check whether the Portuguese documents still match the current product.

5. Verification checklist

• □ Is the application form the Portuguese version in the current format on the ANVISA website?
• □ Are the instructions for use or the user/operator manual in Portuguese?
• □ Is the label model in Portuguese and covering the mandatory items of Art. 47?
• □ Are the remaining documents uniformly in Portuguese, Spanish or English?
• □ Do the Portuguese translations and the English originals agree on terminology and model names?
• □ Are both tiers in one version ledger with source document numbers marked?

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN provides Portuguese language compliance for Brazil — two-tier document triage under RDC 751/2022, terminology tables, sworn-grade translation review for IVD instructions, and version ledgers binding Portuguese outputs to their English sources. For localization support in Brazil, contact GRZAN at info@grzanglobal.com.