Brazilian Market

Welcome to Brazil

The medical device market in Brazil is the largest in Latin America. The market size for medical equipment in 2021 was approximately $11.9 billion, an increase of 6.9% from 2020. Revenue in the Medical Devices market in Brazil is projected to reach US$8.39bn in 2023. The market's largest segment is Cardiology Devices with a projected market volume of US$1.21bn in 2023³. Regulation of medical devices in Brazil is overseen by the National Health Surveillance Agency (ANVISA). Medical devices are categorized into four types: medical equipments, materials for health use, orthopedic implants and in vitro diagnostics. Market authorizations are issued by ANVISA depending on the risk classification of the medical device⁶. The main regulations applicable to the market authorization of medical devices exported to Brazil are Resolution RDC 751/2022 and RDC 665/2022.

Besides that, it should be emphasized that the Brazilian market poses a significant challenge for foreign manufacturers due to the fact that the majority of imported equipment originates from the United States or Europe, accounting for roughly sixty percent of all imported goods. Nevertheless, with the right strategy, international companies can still thrive in this market. Moreover, it's important to acknowledge that the majority of imported devices are sophisticated and custom-made, often leaving no room for Brazilian manufacturers to compete.

Registration Process

Sobel | Your partner on every step

Identify Conformity Route




Appoint Brazialian Registration Holder

for Non-Brazilian Manufacturer

ANVISA Assessment

Audits and technical documentation assessment

Ready to sell

Start commercalization of your product

Our Services

Regulatory Affairs Support

Navigate the complex world of regulatory affairs with our comprehensive Regulatory Service. From strategic planning to gap analysis and continuous support, we ensure alignment with RDC 771/2022 and related regulations for a seamless business operation.

Quality Management Support

Sobel Consultancy’s Quality Management Support offers unparalleled assistance in harmonizing your existing quality management system with the requirements of the Brazilian RDC 665/2022. Whether internal audits, analysis of existing processes, implementation of international standards or a helping hand with daily work? Our experts are ready and waiting.

Risk Management

Manage medical device risks effectively with ISO 14971-based Risk Management Support. Expert planning, comprehensive risk analysis, and effective control measures are at your disposal. A final report evaluates overall risk, ensuring safety and compliance.


Biological Evaluation

Experience seamless Biological Evaluation for medical devices, meticulously aligned with ISO 10993 standards. Our all-inclusive service offers evaluation planning, material characterization, toxicological assessment and study monitoring if needed. Trust our experts to deliver a comprehensive report affirming device safety. With us, you receive the full package, eliminating any concern.


Clinical Evaluation

Experience our Clinical Evaluation Service, meticulously structured to align with Guia nº 31/2020. Tailored for medical devices, it encompasses planning, exhaustive literature reviews, product verifications, validations, and clinical data analysis. Ready for international markets (e.g. Europe, USA)? 

Trust our experts to deliver what you need to be compliant and demonstrating your device’s safety and performance.

Technical File Elaboration

An embodiment of our deep-rooted expertise in compiling robust medical device documentation. This service aligns with RDC 771/2022, guaranteeing a comprehensive, authoritative technical file that resonates with assurance and reliability.

Trust our dedicated problem-solving approach what your technical dossier needs and witness the exceptional difference we bring to your compliance journey.

Brazilian Registration Holder

Secure your place in the Brazilian market with Sobel Consultancy’s Brazilian Registration Holder.

Every foreign manufacturer needs a representative in Brazil. The representative holds the registration and represents him in vigilance issues.

Specialized in medical device representation, we  strengthening your global footprint.


Unleash your potential in the complex realm of medical devices through our comprehensive training programs.

Our curriculum is designed to cater to your specific requirements, ranging from acquiring a deep understanding of RDC 771/2022, MDR 2017/745 fundamentals or conducting meticulous toxicological evaluations.

Rest assured, our training programs are tailored to meet the highest professional standards in the industry.

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