...

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

0 +
Years Experience

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.

Over 3,5K registered hospitals
+ 100K users
All your supplies, one platform.

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

$ 4000 per product/year for the first registration
  • $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

$ 8000 per product/year for the first registration
  • $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.

Testimonials

Learn what it's like to work with Brisa from our clients

Your submission was successful!

In a few minutes our team will contact you, or if you prefer, just click the button below to send a message on our Whatsapp.

Optimized by Seraphinite Accelerator
Turns on site high speed to be attractive for people and search engines.