Entering the Brazilian healthcare market represents a powerful opportunity, but also a unique challenge. As one of the largest and most regulated medical device markets in the world, Brazil combines high growth potential with a complex regulatory, fiscal, and logistical environment.
For global manufacturers, the difference between success and delay often lies in finding a local partner who understands not only Anvisa’s regulatory framework, but also the commercial and operational realities of doing business in Brazil.
At Brisa, we bridge that gap. Through an integrated and strategic approach, we help international manufacturers move from regulatory approval to full market access: safely, efficiently, and with total transparency.
1. Understanding the Brazilian Landscape
Brazil accounts for nearly 40% of Latin America’s medical device market, making it an essential destination for manufacturers seeking regional expansion. However, its complexity (with a detailed regulatory process, layered taxation, and regionalized distribution) demands a structured and localized strategy.
Every successful market entry in Brazil depends on four pillars:
- Regulatory Compliance: navigating Anvisa’s framework for classification, registration, and Good Manufacturing Practice certification (CBPF).
- Legal Representation: establishing a trusted local representative responsible for compliance and communication with Anvisa.
- Tax and Importation Strategy: managing fiscal efficiency and customs procedures under Brazilian law.
- Commercial Integration: connecting with distribution networks, hospitals, and procurement systems.
Brisa’s integrated ecosystem was designed to unify these pillars under one structure, minimizing risks and maximizing predictability.
2. Regulatory Consulting: Building a Strong Foundation
Regulation is the foundation of any market entry strategy. Our team of specialists provides comprehensive regulatory consulting, guiding clients through every step of the Anvisa process: from product classification and dossier preparation to registration and post-market obligations.
We also help manufacturers anticipate changes by monitoring regulatory updates and aligning their documentation with Anvisa’s evolving requirements. This proactive approach reduces approval timelines and strengthens long-term compliance.
3. Legal Representation: Acting as Your Trusted Partner in Brazil
For foreign manufacturers, it is mandatory to have a legal representative established in Brazil, an entity responsible for interacting with Anvisa and ensuring ongoing compliance. At Brisa, we assume this role with full accountability, managing the manufacturer’s regulatory portfolio and guaranteeing alignment with all local obligations.
Our governance model ensures transparency in every process, providing clients with real-time visibility of documentation, renewals, and regulatory milestones.
By acting as both representative and strategic advisor, we enable manufacturers to operate confidently in the Brazilian market.
4. Importation and Logistics: Turning Strategy into Operation
Once the product is approved, success depends on how efficiently it reaches the market. Brazil’s tax and customs landscape can be intricate, involving multiple authorities and state-level regulations.
Brisa manages the entire importation and logistics process, combining fiscal planning, warehousing, and distribution oversight to ensure compliance and efficiency.
We integrate regulatory and operational data into a single system, enabling faster clearance, accurate tracking, and full traceability.
This approach transforms potential bottlenecks into competitive advantages.
5. Commercial Integration: Connecting Innovation to the Market
Our role does not end with importation; we help manufacturers connect with the healthcare ecosystem. Through our strategic distribution network, Brisa facilitates market reach, connecting products with private hospitals, purchasing groups, and institutional buyers.
By aligning regulatory compliance with commercial execution, we help ensure that innovation not only enters the country but also reaches the patients who need it most.
6. Conclusion: From Entry to Expansion
Market entry into Brazil is a journey that demands expertise, foresight, and partnership. At Brisa, we combine all three.
By integrating regulatory consulting, legal representation, importation, and distribution under one ecosystem, we simplify the path for global manufacturers, transforming complexity into clarity and approval into access.
Because in Brazil, success belongs to those who understand that market access is more than registration: it’s strategy.
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
