Brazil's health agency, ANVISA, just dropped its regulatory agenda for 2026-2027, and it’s set to reshape the landscape for medical device manufacturers. This new roadmap signals a major pivot from one-time market approval to a continuous, full-lifecycle approach to regulation, with big implications for SaMD, clinical data, and post-market surveillance.

For any MedTech company with a high-risk device, the pain point is immediate. Your existing FDA or CE Mark clinical data might no longer be enough to secure or maintain your registration in Brazil. You're now facing the challenge of generating local Real-World Evidence, a potentially costly and complex process. But the attraction is clear: successfully navigating these new requirements unlocks continued access to one of the world's most lucrative and rapidly growing healthcare markets.

Key Takeaways:

- How will ANVISA's new agenda impact your 2026 product registration timeline?

- Is your Software as a Medical Device prepared for Brazil's new cybersecurity standards?

- What now constitutes acceptable Real-World Evidence for the Brazilian population?

- Could a new fast-track process for low-risk devices actually increase your compliance burden?

- How does ANVISA's focus on lifecycle management affect your post-market responsibilities?

- Are your global clinical studies designed to meet Brazil's new data expectations?

- What changes do you need to make to your quality management system right now?

At Pure Global, we specialize in turning these regulatory shifts into strategic advantages. With our local expertise in Brazil and advanced AI tools, we develop efficient pathways for regulatory approval, manage technical dossier submissions, and act as your local representative to ensure you not only enter the market but thrive in it. Don't let regulatory changes disrupt your plans. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.