With one of the largest healthcare markets in the world and a highly structured regulatory framework, Brazil stands as the main gateway to Latin America for medical device manufacturers.
The country represents nearly 40% of the region’s medical device market, serving as both a key consumer base and an operational hub for regional expansion.
But what makes Brazil such a strategic point of entry is not only its size: it’s the combination of regulatory maturity, market sophistication, and growing demand for healthcare innovation.
A Market of Scale and Opportunity
Brazil’s healthcare sector is unique in its scale and diversity.
The country has more than 7,000 hospitals, a robust private sector, and a universal public health system (SUS) that provides care for approximately 70% of the population.
This ecosystem drives a continuous need for diagnostic, therapeutic, and monitoring technologies, creating opportunities for global manufacturers in areas ranging from hospital infrastructure to digital health and home care devices.
Moreover, Brazil’s healthcare expenditure accounts for around 9% of GDP, placing it among the top global markets for medical technology investment.
A Mature and Predictable Regulatory Environment
Brazil’s regulatory authority, Anvisa, is recognized as one of the most advanced in Latin America.
Its frameworks, harmonized with international standards such as those of the IMDRF and the World Health Organization (WHO), provide a solid base for manufacturers to operate with clarity, traceability, and long-term predictability.
Recent updates, such as RDC 751/2022, have modernized the classification and registration of medical devices, aligning Brazil’s system more closely with that of the European Union and the United States.
This alignment simplifies global compliance and reduces redundancies for companies already operating in highly regulated markets.
From Local Compliance to Regional Expansion
Many international manufacturers choose Brazil not only for its domestic potential but as a strategic hub for entry into other Latin American markets such as Chile, Colombia, Peru, and Argentina.
Once a company establishes local representation, obtains registration with Anvisa, and aligns its operations with Brazilian Good Manufacturing Practice (CBPF) certification, it gains a significant advantage for regional harmonization and mutual recognition.
In this way, Brazil becomes more than a market: it becomes a platform for regional growth.
Brisa’s Role in Connecting Global Innovation to Latin America
At Brisa, we specialize in helping international manufacturers navigate the Brazilian regulatory landscape and expand strategically across Latin America.
Through our integrated ecosystem, combining regulatory consulting, importation, legal representation, and distribution, we turn compliance into a seamless process that accelerates market entry.
Our expertise allows clients to transition from regulatory complexity to commercial opportunity, ensuring that innovation reaches healthcare providers and patients efficiently and sustainably.
Conclusion: A Market that Leads and Connects
Brazil’s size, regulatory maturity, and growing healthcare demand position it as Latin America’s natural gateway for medical technology.
For manufacturers looking to expand in the region, investing in a structured and compliant operation in Brazil is not just an entry point: it’s a strategic move for long-term growth.
At Brisa, we help global innovators take that step with confidence, connecting regulation, business, and access across borders.
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
