Certificate of free sale for Brazil market authorization

1. Key takeaways

The certificate of free sale (CFS) is one of the mandatory documents for an imported device to obtain marketing authorization in Brazil, and it is not filed only once: Art. 14 item IV of RDC 751/2022 fixes the issuing authority, the authentication method and the translation requirement in one place, and the document’s effect runs through every revalidation within the 10-year validity period. For Class III (high risk) and Class IV (highest risk) devices, the CFS also decides whether the optimized review procedure effective June 3, 2024 can be leveraged. Planning the CFS as a recurring asset with expiry tracking, rather than a one-off attachment, is what separates submissions that move from submissions that stall at the document check.

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. 14 item IV, Art. 14 item V and §§2 and 3, Art. 11
• Optimized Review Procedures — IN No. 290/2024, issued on April 4, 2024, effective June 3, 2024, Arts. 2, 3 and 4
• In Vitro Diagnostic Medical Devices — RDC No. 830/2023, published on December 11, 2023 (DOU 234), effective June 1, 2024 (Art. 71), Art. 12

3. Expert insights

Art. 14 item IV carries several key qualifiers: the issuing authority is the competent authority of the country where the device is manufactured and sold, or of the country of sale only; the document must be consularized or notarized; and languages other than Portuguese, English or Spanish require a sworn translation. GRZAN’s judgment is that the expression country of sale only gives the Chinese mainland companies room to maneuver — a product manufactured in China but sold mainly in a third country may consider issuance by the competent authority of the actual country of sale, yet the document must remain self-consistent with the manufacturing-country information and must not contradict the manufacturing-unit information in the technical dossier.

The second pitfall is the understanding of equivalent documents. The rule permits a marketing authorization certificate, a free sale certificate or an equivalent document, but what ANVISA genuinely wants to see is that the product is in legal open sale in the country of origin. An NMPA registration certificate of the Chinese mainland and an export sales certificate are not equal in probative force, and GRZAN recommends using, as the principal document, one that directly evidences the legal open-sale status, with the registration certificate as supporting evidence rather than the other way around.

Third judgment: the CFS is a linked asset of optimized review. IN 290/2024 (effective June 3, 2024) allows first marketing authorization applications for Class III and Class IV devices to leverage the review outcomes of an equivalent foreign regulatory authority (EFRA / AREE), provided approval has been granted by that authority; devices approved through simplified procedures do not qualify and must follow the standard review. Australia’s TGA, Canada’s Health Canada, the United States FDA and Japan’s MHLW/PMDA are among the recognizable EFRA authorities. Where a company’s foreign approvals come from these bodies, the CFS and the approval evidence should be prepared as one package.

Fourth trade-off: Art. 14 item V and §§2 and 3 require the good manufacturing practice certificate (CBPF) or its receipt to be submitted in parallel, and the grant of the marketing authorization is conditional on the CBPF being published in the DOU. On sequencing, the CFS and the CBPF should advance in parallel rather than serially waiting on each other. The marketing authorization is valid for 10 years (Art. 11), and the CFS must be re-checked at every revalidation.

Fifth judgment: IVDs run on the RDC 830/2023 channel, where the document logic matches but the time pressure differs. Arts. 67 and 68 leave a 365-day transition for control materials without assigned values and DNA/RNA extraction products, counted from the effective date of that resolution; the CFS and compliance documents for exactly these products must be back-planned against the transition deadline rather than following the ordinary device rhythm. Sixth judgment: verify the CFS content against the submitted model list, not just the company name. When a group certificate covers a family of products, ANVISA still expects each submitted model to be identifiable in the document, and a mismatch between the certificate’s product descriptions and the technical dossier’s models is treated as an inconsistency between the dossier and its own supporting evidence — a defect that is cheap to prevent at issuance and expensive to cure by reissuing a consularized document abroad.

4. Practical recommendations

• Confirm the issuing country first: the country of manufacture and sale, or the country of sale only, consistent with the manufacturing unit in the technical dossier.
• Complete consularization or notarization, and prepare a sworn translation when the language is not Portuguese, English or Spanish.
• Choose as the principal document one that directly evidences legal open-sale status, with the registration certificate as supporting evidence.
• Advance the CFS and the CBPF application in parallel to avoid serial waiting that stretches the overall timeline.
• Where optimized review is intended, verify that EFRA approval evidence meets Art. 3 of IN 290/2024 and exclude devices approved through simplified procedures (Art. 4).
• Align the CFS validity with revalidation milestones and maintain an expiry-reminder ledger to avoid last-minute renewals.
• When one CFS is shared across products in a group, verify product-by-model that the product information and manufacturing country appear on the document.

5. Verification checklist

• □ Was the CFS issued by the competent authority of the country of origin?
• □ Was consularization or notarization completed?
• □ Is a sworn translation attached when the language is not Portuguese, English or Spanish?
• □ Does the manufacturer information on the CFS match the technical dossier and the LOA?
• □ Are the CBPF or its receipt available in parallel?
• □ Was the CFS updated before each revalidation milestone?
• □ When one CFS covers multiple products, was product information verified model by model?

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN manages certificate of free sale strategies for Brazil — issuing-country selection, consularization, sworn translations and expiry ledgers — and integrates them with CBPF filings and optimized review eligibility under IN 290/2024. For CFS and market authorization support in Brazil, contact GRZAN at info@grzanglobal.com.