Registering FDA-Compliant Medical Devices in Brazil: A Guide to ANVISA Requirements

Introduction

Brazil’s National Health Surveillance Agency (ANVISA) oversees the registration of medical devices, ensuring they meet safety, efficacy, and quality standards before entering the countries market. Manufacturers of FDA-compliant devices (those already cleared or approved by the U.S. Food and Drug Administration), Brazil offers pathways that can leverage U.S. approvals to streamline the process. This is particularly relevant for devices classified under FDA Classes I, II, and III, which generally align with ANVISA's risk-based classes but may require reclassification under Brazilian rules.

ANVISA classifies medical devices into four risk classes: Class I (low risk), Class II (medium risk), Class III (high risk), and Class IV (maximum risk). FDA Class I devices typically map to ANVISA Class I, FDA Class II to ANVISA Class II, and FDA Class III to ANVISA Class III or IV, depending on specific risk factors such as invasiveness or life-sustaining functions. The registration process differs by class: lower-risk Classes I and II use a simplified "Cadastro" (notification) pathway, while higher-risk Classes III and IV require the more rigorous "Registro" (registration) pathway.

Foreign manufacturers without a Brazilian presence must appoint a Brazil Registration Holder (BRH)—a local entity authorized to handle submissions, maintain records, and act as the legal representative. All labeling and Instructions for Use (IFU) must be in Portuguese, and devices may require additional certifications like INMETRO (for electrical safety) or *ANATEL (for wireless components).

This article outlines the registration process for FDA-compliant devices in ANVISA Classes I, II, and III, including recent regulatory updates, timelines, and required documents. Note that while FDA compliance can facilitate aspects like quality system recognition, full ANVISA approval is still required.

*An INMETRO document is a certification issued by the National Institute of Metrology, Quality and Technology in Brazil.

** ANATEL documents are official certifications or approvals issued by the Brazilian National Telecommunications Agency

Recent Updates to ANVISA Regulations

ANVISA has introduced several updates to align with global standards and improve efficiency, particularly for higher-risk devices:

• IN 290/2024 (Effective June 2024): They introduced a "regulatory reliance" mechanism for Class III and IV devices, allowing ANVISA to leverage approvals from Equivalent Foreign Regulatory Authorities (AREEs), including the FDA (via 510(k) clearance, Premarket Approval (PMA), or De Novo classification). The device must be identical to the FDA-approved version. This can reduce review times by at least 30%, thus ANVISA focusing on key differences rather than a full re-evaluation.

• Unique Device Identification (UDI) System (RDC 591/2021): Mandatory implementation began in July 2025 for Class IV devices, with phased rollouts for Classes III (January 2026), II (July 2026), and I (January 2027). Manufacturers must register devices in ANVISA's UDI database and apply standardized labels. This enhances traceability and post-market surveillance.

• RDC 751/2022: Updated the classification rules and technical dossier requirements, harmonizing with international standards like ISO and IMDRF. It mandates a structured technical dossier for all classes, with evidence of safety, performance, and clinical data.

• RDC 837/2023: Modernizes clinical trial requirements for medical devices, requiring ANVISA approval for studies involving higher-risk devices.

• Regulatory Agenda 2024-2025: Includes 172 topics, with focus on post-market surveillance, digital health, and further reliance pathways. As of August 2025, ANVISA continues to prioritize efficiency amid growing imports.

These updates reflect Brazil's push toward regulatory harmonization, benefiting FDA-compliant manufacturers by reducing duplication.

Registration Process Overview

1. Classification Confirmation: Use ANVISA's rules (RDC 751/2022) to confirm class. If uncertain, submit a classification request via ANVISA's portal.

2. Appoint BRH: Select an independent BRH for flexibility in distribution.

3. Quality System Compliance: Comply with Brazilian Good Manufacturing Practices (BGMP). For Classes II and III, obtain a BGMP certificate via ANVISA audit (or leverage MDSAP results from FDA inspections).

4. Prepare Dossier and Submit: Via ANVISA's electronic system (Solicita).

5. Post-Approval: Monitor for renewals and post-market obligations.

For FDA-compliant devices, include proof of FDA authorization to leverage reliance (for Class III).

Timelines

Timelines vary by class and completeness of submission. Reliance pathways can accelerate higher-class reviews.

ANVISA Class	Pathway	Typical Timeline	Notes
Class I	Cadastro (Notification)	15-30 days	Immediate if complete; no ANVISA review.
Class II	Cadastro	1-3 months	Includes BGMP certification (up to 8 months if audit needed).
Class III	Registro	4-15 months	30% faster with FDA reliance; BGMP audit adds time.

Cadastro approvals do not expire; Registro approvals last 10 years, with renewal 6-12 months prior. BGMP certificates are valid for 2 years.

Required Documents

Documents must be in Portuguese or accompanied by sworn translations. Foreign documents (e.g., FDA certificates) require apostille (since both U.S. and Brazil are Hague Convention members) for authentication. Notarization is needed before apostille for certain docs like powers of attorney or certificates. Embassy authentication (consularization) is rare but may apply if apostille is insufficient or for non-Hague elements; always confirm with BRH. Sworn translations are required if not in Portuguese, English, or Spanish.

Common Documents for All Classes

• Application form (via ANVISA portal).

• Proof of fee payment.

• Letter of Authorization/Power of Attorney for BRH (notarized and apostilled).

• Company registration details (e.g., Articles of Incorporation; apostilled if foreign).

• Proof of home country approval (e.g., FDA 510(k)/PMA certificate; apostilled).

• Labeling and IFU in Portuguese.

Class-Specific Documents

Class I (Cadastro - Notification)

• Technical Dossier (kept by BRH, not submitted): Includes device description, risk management, essential principles checklist, usability studies, global marketing history, manufacturing flowchart, clinical evidence summary, biocompatability/sterilization data (if applicable).

• Additional certifications (e.g., INMETRO if electrical; notarized copy).

• No BGMP certificate required.

• Authentication: Apostille for foreign proofs; notarization for authorizations.

Class II (Cadastro)

• Same as Class I, plus BGMP certificate or MDSAP evidence (apostilled if foreign).

• Technical Dossier must include evidence of compliance with standards (e.g., ISO 13485).

• Authentication: Same as Class I; BGMP docs may need apostille if leveraging FDA QSR.

Class III (Registro)

• Full Technical Dossier (submitted to ANVISA): As above, plus comprehensive clinical data/studies, risk analysis, performance evidence per RDC 751/2022.

• BGMP certificate (mandatory; leverage FDA via MDSAP).

• For reliance: Signed declaration (Annex I template), FDA authorization evidence (apostilled), IFU from U.S. market (translated if needed).

• Notarized INMETRO certificate (if applicable).

• Authentication: Apostille for all foreign docs (e.g., FDA cert, clinical reports); notarization for declarations/authorizations; sworn translations for non-Portuguese content.

Conclusion

Registering FDA-compliant medical devices with ANVISA is feasible and increasingly efficient, thanks to reliance pathways and harmonized standards. Start by confirming classification and appointing a BRH, then prepare authenticated documents. Consult experts for compliance, at ME Dorat Consulting (medorartconsult.com) for a free consultation, as delays from incomplete submissions or authentication issues are common. For the latest details, also visit ANVISA's website.