In the medical device industry, no one grows alone.
Regulatory complexity, tax burden, and logistical challenges make it essential to establish strategic partnerships among manufacturers, distributors, consultancies, and local operators.
More than a trend, this integration has become a key driver of competitiveness and sustainability.
At Brisa, we believe that strong partnerships are the link connecting innovation, regulation, and access.
An industry that depends on synergy
The healthcare sector is made up of an extensive chain, from technology development to clinical use, and every link must operate in synergy to ensure safety and efficiency.
Manufacturers, distributors, and service providers work in a highly regulated environment, and collaboration among them is what ensures that innovation reaches the market sustainably.
Strategic partnerships make it possible to eliminate redundancies, optimize processes, and share regulatory intelligence, leading to greater predictability and reduced costs.
Partnerships that expand access and reduce barriers
For international manufacturers, Brazil represents a promising but technically demanding market.
In this context, partnering with specialized consultancies and experienced local operators is the most effective way to overcome entry barriers and ensure compliance with Anvisa’s requirements.
An experienced partner provides not only operational support, but also strategic insight into taxation, logistics, regulation, and market positioning.
When well structured, such collaboration transforms regulatory challenges into a true competitive advantage, especially in the context of MDSAP and GMP good practices.
Integration and transparency as pillars
The ideal partnership model is built on integration and transparency.
Each participant understands its role in the product lifecycle and acts with a shared commitment to sustainable results.
At Brisa, we work through a collaborative approach, connecting manufacturers, distributors, and purchasing groups within an integrated regulatory ecosystem that enables data sharing, timeline optimization, and coordinated market access strategies.
This model is especially relevant for companies seeking FDA registration and needing to navigate simultaneously through Brazilian and North American regulatory systems.
The Brisa ecosystem as a model of collaboration
The Brisa ecosystem was designed to bring together all players in the healthcare chain around a common goal: facilitating access to innovative medical technologies in Brazil.
Our model combines:
Specialized regulatory consulting: ensuring the safe and efficient entry of products, including support for medical device consulting and compliance with Anvisa standards.
Importation and legal representation: with optimized fiscal and logistical structures, facilitating contact Anvisa and processes with authorities such as the Medical Device Authority and Health Sciences Authority.
A strategic distribution network: linking manufacturers to regional buyers and healthcare institutions.
Comprehensive governance and traceability: ensuring compliance at every stage, including UDI requirements and product identification systems.
This collaborative format reduces costs, shortens timelines, and expands access to essential medical technologies, benefiting manufacturers, distributors, and Brazil’s healthcare system as a whole.
Conclusion: collaboration as a driver of innovation
Today, healthcare innovation depends not only on technology, but on the quality of the partnerships that support it.
Building strategic alliances based on trust, transparency, and shared objectives is what turns projects into measurable results.
At Brisa, we believe the future of healthcare is collaborative, integrated, and sustainable, which is why partnerships are at the heart of our ecosystem.
For companies seeking to better understand the Brazilian regulatory framework and optimize their market entry strategies, having partners who master everything from RDCs to international requirements of Health Products Regulatory Authority and Medical Products Agency makes all the difference.
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
