Selling Medical Devices in Brazil (Without Tears): A Straightforward Step-by-Step Guide

Selling medical devices in Brazil goes beyond regulatory compliance. It is a strategic market access decision shaped by evolving rules, faster approval pathways, and closer alignment with global regulatory systems.

In recent years, Brazil’s framework has evolved with new mechanisms such as reliance pathways, updated classification rules, and UDI requirements, changing how manufacturers approach market entry. Understanding how this system works, and how it connects to approvals from FDA, EU MDR, Health Canada, and TGA, is essential to enter the market efficiently and avoid delays.

In this guide, we break down the full process step by step so you can understand how to enter the Brazilian market in a structured, predictable, and compliant way.

Key takeaways

• Brazil is one of the largest and fastest growing healthcare markets in Latin America, driven by strong public and private healthcare demand
• Regulatory modernization including RDC 751/2022, RDC 591/2021, and IN 290/2024 is improving speed but increasing the need for precise strategy
• Reliance pathways now allow faster approvals for devices already authorized in trusted markets
• Most delays in Brazil are still caused by strategy issues rather than regulation itself, especially classification, documentation, and local representation

Brazil is the largest healthcare market in Latin America and among the ten largest worldwide. With over 213.4 million inhabitants, its public healthcare system (SUS – Sistema Único de Saúde) covers more than 75% of the population, creating sustained demand for medical devices.

The private healthcare sector also plays a major role, with one of the largest hospital and diagnostic networks in the region, continuously investing in advanced medical technologies.

Key opportunities include:

• Access to a massive patient population
• Strong import demand for innovative and high-value medical devices
• Growing regulatory alignment with international standards (EU MDR, FDA, ISO 13485)
• New reliance pathways (IN 290/2024) reducing approval timelines

Brazil is the gateway market to Latin America.

Approval in Brazil depends heavily on how well the regulatory strategy is prepared before submission to Anvisa (Agência Nacional de Vigilância Sanitária).

Even well-developed products can face delays if the regulatory approach is not adapted to local expectations and documentation standards.

Typical factors behind submission delays include:

• Choosing a regulatory route that does not match the device classification or intended use
• Technical files that are complete globally but not fully aligned with Brazilian requirements
• Gaps between international regulatory strategy and local Anvisa expectations
• Underestimating local requirements such as Portuguese documentation and the role of the Brazilian registration holder

With early planning and a structured regulatory approach, these issues can usually be anticipated and managed before submission.

Brazil has significantly modernized its regulatory framework, aligning more closely with global standards.

RDC 751/2022 is the core regulation governing how medical devices are classified and authorized in Brazil. It establishes the framework used by Anvisa to determine the applicable regulatory pathway and documentation requirements.

It defines:

• Risk classification rules, ranging from Class I (low risk) to Class IV (high risk), based on intended use and level of patient risk
• The applicable pathway, either Notification for lower-risk devices or full Registration for higher-risk devices
• Labelling and Instructions for Use requirements, including mandatory content, structure, and adaptation to Brazilian Portuguese

The regulation also aligns Brazil more closely with international systems, particularly the EU MDR classification logic, making it easier for manufacturers to leverage existing documentation when properly adapted. 

Correct application of RDC 751/2022 is critical, as classification directly impacts timelines, costs, and the overall approval strategy.

RDC 591/2021 establishes the Unique Device Identification (UDI) framework in Brazil, introducing traceability requirements across the device lifecycle. 

It aligns with: 

• FDA UDI system  
• EU MDR and EUDAMED requirements  

Manufacturers must assign a UDI to each device and ensure consistent identification across labelling, documentation, and regulatory submissions. Implementation follows a phased approach based on device risk class. 

Early alignment with global UDI systems helps avoid duplication and simplifies compliance across multiple markets.

IN 290/2024, the Reliance Pathway, allows Anvisa to rely on approvals from trusted authorities to speed up review. 

It applies to devices already approved by: 

• FDA  
• TGA  
• PMDA  
• Health Canada 

Applicants must show essential equivalence with the approved device and provide supporting foreign authorization documents. This pathway can significantly reduce approval timelines when eligible. 

RDC 687/2022 establishes the requirement for CBPF (Certificação de Boas Práticas de Fabricação) for medical device manufacturers in Brazil. 

It is aligned with: 

• ISO 13485  
• FDA QSR principles 

CBPF confirms that manufacturing processes meet Anvisa’s quality and safety standards and is typically required for higher-risk devices. It can also be supported by international audit programs such as MDSAP.

You need a local company in Brazil (CNPJ) to hold the product registration with Anvisa. 

This company must have AFE (authorisation to operate) and is usually your importer or distributor. 

Make sure the contract clearly defines who is responsible for post-market surveillance and safety reporting.

Devices in Brazil are classified based on risk, from Class I (low risk) to Class IV (high risk). 

This classification determines the regulatory pathway: 

• Class I and II → Notification  
• Class III and IV → Full Registration  

Getting the classification wrong is one of the most common reasons for delays in approval. 

For Class III and IV devices, CBPF (Good Manufacturing Practice Certification) is often required. 

It is issued by Anvisa and confirms that the manufacturer meets quality and safety standards. 

In some cases, MDSAP audit reports can be used to support the CBPF application.

Your dossier must include: 

• Labelling & IFU in Brazilian Portuguese (RDC 751/2022)  
• UDI compliance (RDC 591/2021)  
• Safety & performance data aligned with EU MDR-style documentation  
• Clinical justification based on risk class  

• Proof of approval by AREE authority  
• Evidence of essential equivalence  
• Adapted labelling/IFU  

All applications go through Solicita. 

• Notification → Class I–II  
• Registration → Class III–IV  

• Foreign approval certificate  
• Equivalence declaration  
• Brazilian-compliant labelling  

Before importing medical devices into Brazil, the product must be properly regularized with Anvisa. 

This process requires an Import Licence (LI) issued through the Siscomex system. 

Anvisa approval is mandatory before customs clearance is granted.

Under RDC 591/2021, UDI is required for medical devices in Brazil with a phased implementation schedule. 

The system must follow international standards such as GS1 or HIBCC to ensure global traceability. 

It is aligned with FDA UDI and EU EUDAMED requirements, so early integration helps avoid rework and delays later in the process.

Brazil has strict vigilance requirements: 

• Tecnovigilância (RDC 67/2009) → adverse event reporting via Notivisa  
• Field Actions (RDC 551/2021) → recalls, corrections, software updates, and customer communications 

Equivalent to: 

• EU FSCA  
• FDA recall system (21 CFR Part 806)  

A successful regulatory strategy in Brazil is usually built before operational execution and aligned with local requirements from the beginning. This reduces rework, delays, and unexpected gaps during submission. 

Practical approaches that improve efficiency include: 

• Defining the regulatory strategy before selecting a local partner to ensure alignment on responsibilities and pathway  
• Using RDC 751/2022 as a structured compliance checklist rather than a reference document  
• Leveraging MDSAP audit reports to support CBPF requirements where applicable  
• Preparing Portuguese Instructions for Use early to avoid late-stage translation and adaptation issues  

Using the Reliance pathway (IN 290/2024) when eligibility criteria are met to shorten approval timelines

Entering or expanding in the Brazilian market can become significantly more complex depending on the device portfolio and regulatory pathway involved. In some cases, internal teams can manage the process, but external expertise becomes valuable when complexity increases or timelines are critical. 

It is recommended to seek regulatory support in situations such as: 

• First entry into Brazil  
• Multiple Class III–IV devices  
• UDI implementation across portfolio  

Complex Reliance submissions  

1. Appoint Brazilian Registration Holder (CNPJ + AFE)  
2. Classify device (RDC 751/2022)  
3. Choose Notification vs Registration  
4. Obtain CBPF if required  
5. Prepare full technical dossier  
6. Apply Reliance if eligible (IN 290/2024)  
7. Submit via Solicita + Import Licence (LI)  
8. Maintain post-market surveillance  

Brazil is complex, but it follows a structured and predictable regulatory system when approached correctly. 

With the right strategy in place, including correct classification, an appropriate local registration holder, a clear CBPF approach, compliant labelling and UDI implementation, and effective use of the Reliance pathway, the approval process becomes much more manageable. 

Instead of being a barrier, Anvisa becomes a defined market access pathway to one of the largest healthcare markets in the world. 

Contact us today to discuss your project and get guidance on Brazilian medical device market access.