BRAZILIAN REGISTRATION HOLDER SERVICE BY MEDAGENT
Your Strategic Partner for the Brazilian Medical Device Market since 2012.
Since 2012, MEDAGENT has been providing comprehensive support to international medical device manufacturers entering the Brazilian market. As your Brazilian Registration Holder, we stand by you with expertise and experience to successfully navigate Brazil’s regulatory challenges.
Our Role as Your Brazilian Registration Holder
MEDAGENT do Brasil acts as a registered technical representative at ANVISA, responsible for complying with Brazilian regulatory standards.
We manage the registration of your products with ANVISA, including the preparation and submission of the required technical documentation.
For certain product classes, we assist with compliance to Brazilian Good Manufacturing Practices (B-GMP) and INMETRO certification. This includes audits, documentation reviews, and annual inspections.
Why Choose MEDAGENT as Your Brazilian Registration Holder?
With over a decade of experience in the Brazilian market, we have an in-depth understanding of local regulatory requirements and processes.
From product registration to compliance monitoring, we offer a complete service to successfully place your products in Brazil.
We stand for transparency, efficiency, and close collaboration with our clients.
Contact us
If you want to learn more about our Brazilian Registration Holder Service or wish to avail of it, contact us today. We are ready to support you on your journey to success in the Brazilian medical device market.
Contact Brazilian Registration Holder
Contact us to find out more about the MEDAGENT service and the procedure for registering medical devices in Brazil.