Navigating the intricacies of registering medical devices in Brazil is a challenging yet promising endeavor, especially with the expanding strategic partnerships of Endo Americas. The Brazilian market, being the second largest in the western hemisphere, presents substantial opportunities, within a regulatory landscape that can be intricate.
For those contemplating the introduction of their medical devices into this dynamic market, it’s crucial to recognize the complexities of the regulatory environment. Initially, when we ventured into this arena, we encountered conflicting information from various professionals, resulting in significant time and financial investments. Over the years, we’ve accumulated substantial knowledge and expertise, now boasting a dedicated team focused on regulatory affairs, quality, and compliance. Additionally, our seasoned sales force, comprising professionals from diverse medical backgrounds such as urology, gynecology, orthopedic surgery, and spinal health, adds a unique dimension to our capabilities.
The regulation and sale of medical devices in Brazil vary based on the risk class, often necessitating intricate certifications and annual audits to obtain and maintain ANVISA clearance. This process can be time-consuming and financially demanding. Here, Endo Industries steps in as a strategic partner, offering diverse business models to streamline the entry process. These models include OEM agreements with direct distribution through our platform or indirect distribution OEM, wherein we handle product registration and dispatch products to a distributor of your choice.
With Endo Industries, we can expedite your entry into the Brazilian market, typically achieving this within as little as 60 days (subject to the risk class of the product). Leveraging our state-of-the-art factory and distribution center, along with our ISO13485, Anvisa and Inmetro certifications, we provide a robust foundation for market entry. Whether distributing your products or assisting in finding a suitable distribution channel, we can manage your registration, ensuring compliance with the intricate Brazilian regulatory environment, keeping you not only present but thriving in the market.
