In the medical device sector, regulatory approval is a major milestone, but it’s far from the final destination.
Obtaining registration from Anvisa validates a product’s safety and efficacy, but transforming that approval into real, sustainable market access in Brazil requires a much broader set of strategic, operational, and commercial actions.
The real challenge lies in integrating regulation, logistics, taxation, distribution, and governance into a single cohesive structure; something that has traditionally been fragmented across the healthcare industry.
At Brisa, we believe true innovation happens only when technology reaches the patient. And that requires a market access journey designed to be complete, predictable, and collaborative.
1. Approval Is the Beginning, Not the End
Anvisa registration marks the start of a complex journey involving multiple authorities, partners, and operational layers.
It ensures the product’s compliance with safety and quality standards, but it does not automatically guarantee commercialization or adoption within the Brazilian healthcare system.
Between approval and clinical use, several critical steps must occur:
- Logistical structuring: planning importation, warehousing, and distribution.
- Tax and fiscal planning: essential in one of the world’s most complex tax systems.
- Distribution channel design: ensuring traceability, compliance, and national coverage.
- Post-market management: maintaining ongoing product monitoring and performance reporting.
When these stages are handled separately, companies face rework, delays, and additional costs.
But when managed strategically and in coordination, they become a source of efficiency and competitive advantage.
2. Turning Regulation into Access
Anvisa is internationally recognized for its technical rigor and maturity, positioning Brazil as a reference in Latin American regulatory systems. However, this same rigor demands a strategic understanding of the regulatory framework, one that looks beyond documentation to operational and commercial implications.
Market access requires connecting regulation to broader factors, such as:
- Infrastructure and customs logistics;
- Importation and sales taxation;
- Relationships among manufacturers, distributors, and legal representatives;
- Technological and policy trends shaping the healthcare landscape.
Without this integrated perspective, many international manufacturers achieve registration but struggle to enter or sustain operations in the Brazilian market due to tax complexity, lack of local partners, or unpredictable import flows.
3. Market Access Strategy: The Bridge Between Regulation and Commerce
In healthcare, Market Access is much more than a regulatory step. It’s a coordinated process that aligns technical, economic, and strategic factors to ensure that products not only get approved but also reach the Brazilian healthcare system sustainably and at scale.
Its key pillars include:
- Continuous regulatory governance: managing renewals, updates, and ongoing compliance with Anvisa.
- Logistical and tax optimization: leveraging special import regimes and efficient distribution routes.
- Tailored commercial models: addressing both the private market and public procurement opportunities.
- Stakeholder engagement: connecting with distributors, hospitals, and purchasing groups.
When built strategically, market access transforms regulatory compliance into a growth roadmap, reducing risks and increasing predictability.
4. The Brisa Model: Integration as a Competitive Advantage
The Brisa ecosystem was designed to bridge the gap between regulation and market entry. Our integrated model unites all stages of the value chain, from regulatory consulting to commercialization, within a single, transparent, and traceable framework.
This means that international manufacturers gain a local partner capable of managing:
- The entire regulatory process with Anvisa;
- Legal representation and post-market obligations;
- Importation, warehousing, and tax-optimized logistics;
- National distribution and commercialization.
This model ensures efficiency, governance, and cost reduction, while providing predictability for international investors and decision-makers.
The result is a faster, safer, and more competitive pathway into Brazil: a true strategic gateway to the Latin American market.
5. Conclusion: Real Market Access Begins Where Regulation Ends
Regulation is essential, but the real impact of healthcare innovation happens when it reaches professionals and patients.
To achieve this, companies must view regulation as the foundation of a broader process that combines planning, governance, and collaboration.
At Brisa, we transform regulation into a pathway instead of a barrier. Our mission is to turn complexity into predictability, aligning technical compliance with strategic execution and ensuring that innovation completes its journey to where it matters most: improving lives.
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
