- +30 Years of Experience
Legalize Your Medical Devices in Brazil and Unlock Market Access
Complete Market Access + Regulatory Compliance with ANVISA, All in One Package.
Schedule a Free Consultation
Brisa Advisors has been trusted by leading Companies
Imagine entering Brazil's booming medical devices market effortlessly, with every regulatory hurdle handled for you.
With Brisa, that’s not just possible; it’s guaranteed.
Navigating Brazil’s market might seem daunting — regulatory complexities, market access barriers.
These challenges are real, but so is the solution. Let’s address these hurdles head-on.
Our marketplace is your gateway to market penetration.
Exclusive Offer: Register Your Medical Products and Unlock Free Market Access!
Select the perfect fit for your product class and streamline your entry into Brazil.
With any package purchase, you receive a one-year marketplace license free, connecting you directly to the Brazilian medical market.
CLASS I AND II
- $500/year for each additional registration
- License holder representation
- Registration, renewals, and modifications
- Post-market vigilance responses
- INMETRO and ANATEL support
- One year of access to our marketplace platform, with 3,5k+ buyers
CLASS III AND IV
- $1000/year for each additional registration
- License holder representation
- Registration, renewals, and modifications
- Post-market vigilance responses
- INMETRO and ANATEL support
- One year of access to our marketplace platform, with 3,5k+ buyers
*A three-year contract is required. Third-party or government fees are not included.
Brazil's Market: huge potential beyond complexity
Sure, stepping into Brazil’s market has its complexities — from intricate distributor networks and detailed tax systems to import regulations, bureaucratic procedures, and compliance with ANVISA, INMETRO, ANATEL, and GMP certification.
But here’s the exciting part: with Brisa Advisors, these complexities become manageable. Our extensive experience, spanning nearly three decades in regulatory, governmental, and commercial domains, equips us to smooth out these hurdles, paving the way for your product’s successful market entry.
Brazil is the largest medical device market in Latin America, pulsating with growth and opportunity. The demand for top-notch healthcare solutions is skyrocketing, creating a fertile ground for manufacturers ready to make a mark.
BRISA ADVISORS
Who we are
Brisa Advisors, a Regulatory Affairs consulting company, has acted for dozens of small, medium, and large international medical device manufacturing companies before ANVISA, such as Colgate Palmolive, Hoechst, Bayer, Sumitomo, and TELEFLEX group.
Acted in the areas of drugs, food, sanitizing products, cosmetics, and mainly medical devices. It stood out in the first merger case in which they acted to change the understanding of the legislation in force, motivating the change of the regulatory framework of ANVISA.
The change provided significant savings to its client in the payment of fees to ANVISA.