Entering the Brazilian market with your IVD device? You’ll need more than technical documentation—you’ll need a trusted Legal Representative in Brazil.
International manufacturers of in vitro diagnostic medical devices (IVDs) must appoint a local entity to act on their behalf before Anvisa. It’s a legal requirement that directly impacts your ability to register and maintain your IVD product in Brazil.
With complex regulatory frameworks, language barriers, and strict vigilance obligations, working with the right Legal Representative for Brazil IVD registration is critical for your success.
We offer expert representation services tailored for IVD medical devices (Class I to IV), ensuring regulatory compliance and operational efficiency in Brazil. Our local support helps bridge the gap between your global operations and Anvisa’s requirements.
Talk to our team and start your Brazil IVD strategy with clarity and confidence.
Sobel acts as your local representative in Brazil, officially recognized by Anvisa to represent your in vitro diagnostic medical devices. This service includes:
With Sobel, your product benefits from a responsive, compliant, and experienced local presence—an essential pillar for success in Brazil.
Appointing a Legal Representative for IVD registration in Brazil is not optional, it’s a regulatory necessity.
Without a recognized legal entity, your IVD medical device cannot be evaluated or approved by Anvisa.
Furthermore, Brazil’s regulatory system requires a local contact for ongoing obligations like vigilance, distributor updates, and agency communications.
Sobel’s experienced team helps you meet these obligations with precision, allowing you to scale your market entry without disruption.
Partner with Sobel as your Authorized Representative in Brazil. With Sobel, you minimize risk, ensure regulatory alignment, and position your IVD product for long-term success in Brazil.
We handle the regulatory complexity, so you can focus on innovation.
Subscribe to our newsletter to receive the latest updates and insights.
You may unsubscribe at any time using the link in our newsletter.
