Brazil is consolidating its position as one of the most promising markets for international medical device manufacturers. With an increasingly mature regulatory environment, growing demand for cutting-edge technologies, and hospitals undergoing full modernization, the country has become a strategic destination for companies looking to expand their global presence.
And with MEDICA 2025 (November 17–20) approaching, this is the ideal time to plan your entry in a structured and secure way.
Why Brazil is a Strategic Opportunity
- The Brazilian medical device market is expected to reach US$25 billion by 2032, according to Fortune Business Insights.
- Imports continue to rise, driven by the search for new technologies by hospitals, clinics, and national distributors.
This combination reveals a clear scenario: there is space and demand for innovative solutions. The challenge, however, lies in efficiently navigating the country’s regulatory and commercial environment.
Essential Requirements for Medical Device Entry into Brazil
Entering the Brazilian market requires more than just a good product. It is necessary to comply with specific technical, legal, and regulatory requirements, supervised by ANVISA (National Health Surveillance Agency).
Key focus areas include:
- Sanitary registration with ANVISA according to the product’s class and risk.
- Mandatory local representative (Registration Holder) for foreign manufacturers.
- Labeling and documentation in Portuguese, including IFU (Instructions for Use).
- Complete technical dossier, covering performance, safety, and validations.
- Clinical evidence for higher-risk products or emerging technologies.
- Compliance with applicable standards.
- Tax and logistical planning for importation and commercialization.
- Market strategy, including distribution channels, pricing, and registration roadmap.
- Alignment with hospital purchasing groups, which are fundamental for commercial penetration.
- Realistic estimates of time and cost – a key point for decision-making.
Brisa Advisors’ Solution: A Complete Ecosystem for International Manufacturers
At Grupo Brisa Advisors, we offer an end-to-end approach for companies that want to access the Brazilian market in a structured and efficient way. Our ecosystem integrates regulatory consulting, legal support, distribution, and connection with buyers—all in a single entry flow.
- Regulatory and Legal Support: We prepare and submit the dossier to ANVISA, handle requirements, and ensure technical and legal compliance.
- Feasibility Analysis & Customized Roadmap: We evaluate risks, requirements, and define realistic timelines and costs.
- Connection with Purchasing Groups and Distributors: We guarantee direct access to the country’s main commercial channels.
- Distribution and Local Operation: We act as a commercialization and distribution partner when desired.
- Technical Consulting and Normative Compliance: Review of labeling, documentation, and safety tests.
With this structure, we help our clients reduce time-to-market, minimize risks, and achieve sustainable results.
Why Choose Brisa Advisors
- Local expertise with national and international presence.
- Integrated teams of regulatory, legal, and commercial specialists.
- Proven track record of success with manufacturers from various segments (IVD, orthopedics, diagnostic equipment, etc.).
- Realistic proposals, based on data and practical experience.
- Over 30 years of experience in the medical device regulatory market.
Invitation to MEDICA 2025
Brisa Advisors will be present at MEDICA 2025, in Düsseldorf, from November 17 to 20.
Our schedule is open for in-person meetings, as well as pre-event appointments, where we will present our ecosystem and a customized proposal for entering the Brazilian market.
📅 Schedule your in-person meeting: https://calendly.com/brisa-advisors/30min
Brisa Advisors – Connecting Global Innovation to the Brazilian Market
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
