Letter of authorization for Brazil notifications and registrations

1. Key takeaways

The letter of authorization (LOA) in Brazil is not a single-stage document: RDC 751/2022 requires imported devices to submit it in 3 stages — notification, registration and revalidation — with the content requirements kept identical across the three places. GRZAN’s judgment is that the high-frequency failure is not failure to file at all, but reusing a LOA from ten years earlier at revalidation. Because the marketing authorization runs for 10 years, every element inside the letter — factory names, addresses, corporate structures, the good manufacturing practice attestation — can drift over a decade, and a stale LOA is the single most common deficiency GRZAN encounters in Brazilian projects.

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. 13 item II and sole paragraph, Art. 14 item III and §1, Art. 27 item I, Art. 10 §6, Art. 11
• Classification, Notification and Registration of Medical Devices — RDC No. 751/2022, decided on September 15, 2022, effective March 1, 2023 (Art. 67), Art. 13 sole paragraph, Art. 14 §1, Art. 27 §1; Good Manufacturing Practices — RDC No. 665/2022, effective May 2, 2022 (Art. 138), Art. 1
• Brazilian Good Manufacturing Practices — RDC No. 665/2022, published on March 30, 2022, effective May 2, 2022 (Art. 138), Art. 1
• Issuance and Renewal of Good Manufacturing Practice Certificates — RDC No. 687/2022, effective June 1, 2022 (Art. 17), Art. 3
• Technovigilance — RDC No. 67/2009, published on December 21, 2009, Art. 3 sole paragraph
• Essential Safety and Performance Requirements — RDC No. 848/2024, published in the DOU on March 8, 2024, Arts. 85 and 88

3. Expert insights

Art. 13 item II (notification), Art. 14 item III (registration) and Art. 27 item I (revalidation) read the same way: a consularized or notarized declaration issued by the legal manufacturer, in Portuguese, English or Spanish, authorizing the applicant company to represent and commercialize its products in Brazil. The sole paragraph of Art. 13 and §1 of Art. 14 further list the content requirements: the full corporate names and complete addresses of the legal manufacturer and the applicant company; an express authorization for the applicant company to represent and commercialize its products; and confirmation that the manufacturer is aware of and complies with the good manufacturing practice requirements for health products under RDC 665/2022.

GRZAN’s judgment is that the three-way consistency is both good news and a trap. The good news: one template needs to be maintained. The trap: revalidation invites reuse of the old version. The marketing authorization is valid for 10 years (Art. 11), and across a decade the factory name, the address, the acquiring entity and the BGMP version can all change; submitting the first-filing LOA at revalidation is the deficiency GRZAN sees most frequently in Brazilian projects.

The second pitfall is treating the compliance attestation as boilerplate. The rule demands not a vague promise but an express reference to the good manufacturing practices for health products established by RDC 665/2022, with forward effect over the regulations that replace it. Wording that only says compliance with Brazilian GMP requirements will be judged as an unclear reference during the content check.

Third judgment: the good manufacturing practice (BPF) statement in the LOA applies to Class I/II as well. The sole paragraph of Art. 13, §1 of Art. 14 and §1 of Art. 27 all require the letter to state the manufacturer’s awareness of and compliance with the BPF requirements of RDC 665/2022; whereas under Art. 3 of RDC 687/2022 only the production units of Class III/IV devices must obtain a good manufacturing practice certificate (CBPF). GRZAN’s judgment: the industry habit of reading no CBPF required for Class I/II as no system responsibility for Class I/II is wrong. The CBPF is a certificate obligation and the BPF statement is a documentary obligation; the two sit on different layers. Class I and II follow the notification route (notificação) without submitting a CBPF, but the BPF statement inside the LOA must still be written, and its absence earns an exigência, the formal deficiency notice.

Fourth judgment: the LOA is the legal instrument of the relationship between the manufacturer and the Brazilian holder, and it also determines the chain of responsibility for later changes, vigilance and field actions. RDC 67/2009 makes the registration holder the legally responsible subject for the products under its name; an authorization scope drafted too narrowly creates a responsibility vacuum when an adverse event must be answered.

A linking note: the LOA and the instructions for use travel in the same submission package. The upload duty for the instructions is governed separately by Art. 33 of RDC 751/2022 and is not expanded here, but companies should schedule it together with the notarization and consularization lead time of the LOA.

Fifth trade-off: Portuguese, English or Spanish are allowed; other languages require a sworn translation. For the Chinese mainland companies, the most robust combination is a Chinese original accompanied by a Portuguese or English translation. Also note that Class I/II notification applications are routine processing with a completion deadline of 30 days (Art. 10 §6), but incomplete files are rejected all the same — a missing LOA element is not waved through just because a deficiency cycle exists.

Sixth judgment: design the LOA together with the Brazilian holder structure. When GRZAN assists clients in fixing the local registration holder structure, the authorization scope and term clauses are settled at the same time, because transfer of registration ownership has its own rules — RDC 903/2024 makes clear that notification-class products (notificação) may not be transferred and must be refiled. Authorization design for Class I/II products therefore has to move one step earlier in the project plan; otherwise any restructuring of the holder creates a gap in the authorization chain exactly when filings are due.

4. Practical recommendations

• One template can cover the three stages, but re-verify the party names and addresses against the latest commercial registry before every submission.
• Write the compliance attestation specifically as RDC No. 665/2022 and the regulations replacing it; avoid generalized wording.
• State the authorization scope explicitly: representation rights, commercialization rights, and the duty to cooperate with vigilance and field actions.
• Back-plan the revalidation file updates against the 10-year validity instead of rushing them at expiry.
• Start the consularization or notarization early and prepare sworn translations as required.

5. Verification checklist

• □ Are the full names and complete addresses of the legal manufacturer and the applicant company present?
• □ Is there an express statement authorizing representation and commercialization?
• □ Is there an awareness-and-compliance confirmation of the BGMP (RDC 665/2022)?
• □ Is the BPF compliance statement in the LOA body (also applicable to Class I/II notification, not waived for lack of a CBPF)?
• □ Is the language Portuguese, English or Spanish, and otherwise accompanied by a sworn translation?
• □ Was the notarization or consularization completed before submission?

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN drafts and maintains letters of authorization for Brazil — consularization and notarization, BPF attestations aligned with RDC 665/2022, and revalidation refreshes across the 10-year validity — and designs them together with the local holder structure. For LOA and dossier support in Brazil, contact GRZAN at info@grzanglobal.com.