Top 5 Medical Device Compliance Mistakes to Avoid in Brazil

Introduction

Brazil is one of Latin America’s largest and most complex medical device markets, governed by the National Health Surveillance Agency (ANVISA). Manufacturers aiming to enter this market must navigate a stringent regulatory framework to obtain and maintain market authorization. Despite clear guidance from ANVISA, companies frequently make avoidable mistakes that delay product approval or lead to non-compliance.

This article outlines five common compliance pitfalls encountered by medical device manufacturers and offers practical guidance for avoiding them.

 1. Incorrect Medical Device Classification

Brazil uses a four-tier classification system (Classes I to IV), based on risk, similar to the GHTF model. This classification determines the registration pathway and documentation required.

Common Mistake: Assuming that the classification used in the EU or US will apply directly in Brazil, which can result in incomplete dossiers or use of the wrong regulatory pathway.

How to Avoid It: Assess device classification using the specific rules outlined in RDC 751/2022, which replaced RDC 185/2001. Carefully review each rule in relation to the device’s intended use, mode of operation, and risk profile.

2. Incomplete or Non-Compliant Technical Documentation

ANVISA requires detailed technical documentation tailored to local regulations, including safety and performance data, clinical evidence, and manufacturing controls.

Common Mistake: Submitting technical files based on FDA 510(k) or CE Mark templates without adapting to ANVISA’s specific structure and language requirements.

How to Avoid It: Structure documentation according to IN 10/2021, which outlines the Device Dossier format for Class III and IV devices. Include all mandatory elements, such as the Declaration of Conformity, labeling in Portuguese, and risk-benefit analysis aligned with Brazilian standards.

3. Neglecting Local Registration Holder Requirements

Foreign manufacturers cannot register directly with ANVISA. A local Brazilian company must act as the registration holder (also known as the “legal representative”).

Common Mistake: Selecting a distributor as the registration holder without clearly defining contractual boundaries, potentially limiting control over registration rights.

How to Avoid It: Consider appointing a neutral third-party registration holder or ensure contracts allow the manufacturer to retain ownership of the product license. Maintain registration independence from commercial distribution agreements.

 4. Non-Compliant Labeling and Instructions for Use (IFU)

Labeling and IFU must comply with ANVISA’s standards, including being in Brazilian Portuguese and reflecting local regulatory information.

Common Mistake: Using translated versions of labels from other markets without adapting content to local requirements, such as CNPJ (Brazilian Tax ID), ANVISA registration number, and correct terminology.

How to Avoid It: Refer to labeling requirements in RDC 751/2022 and ensure compliance with local standards. Instructions for Use should be culturally and linguistically adapted, not simply translated.

 5. Failing to Implement Post-Market Surveillance (PMS) Obligations

ANVISA places strong emphasis on post-market monitoring through its vigilance system

Common Mistake: Treating PMS as a reactive obligation only triggered by adverse events. Proactive activities such as trend analysis and periodic reporting are often overlooked.

How to Avoid It: Establish a local PMS plan aligned with ANVISA’s vigilance guidelines. For higher-risk devices, integrate PMS into the quality system and ensure the Brazilian representative is trained on incident reporting protocols.

 Conclusion: Proactive Planning is Key to Compliance

Compliance with Brazil’s regulatory framework requires thorough preparation and attention to detail. By avoiding these common mistakes and adhering to the latest ANVISA requirements, manufacturers can streamline their market entry process and ensure long-term regulatory success.

Sources

• ANVISA RDC 751/2022: https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-751-de-15-de-setembro-de-2022-431785368
• IN 10/2021: https://www.in.gov.br/en/web/dou/-/instrucao-normativa-n-10-de-11-de-agosto-de-2021-338914251
• ANVISA Main Portal: https://www.gov.br/anvisa/pt-br
• Brazilian Ministry of Health: https://www.gov.br/saude/pt-br
• WHO: Country Cooperation Strategy Brazil: https://www.who.int/publications/i/item/ccs-brazil