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Brazil's SaMD Shift: Pure Global on ANVISA's 2026 Regulatory Gambit
Brazil's health agency, ANVISA, has just unveiled its ambitious 2026-2027 regulatory agenda, signaling one of the most significant shifts in the Latin American MedTech landscape in years. This isn't just a minor update; it's a fundamental move towards stricter, globally harmonized standards that will redefine market access.
This episode of LATAM MedTech Insights dives deep into the two most critical changes: a complete overhaul of the rules for Software as a Medical Device (SaMD) and the game-changing proposal to make MDSAP audits mandatory for all manufacturers. We break down the immediate operational and strategic impact these changes will have on your business.
A US-based digital health startup just received FDA clearance for its AI-powered diagnostic tool. They saw Brazil as their next big market, but the planned revision of RDC 657 means their existing validation data might be insufficient for ANVISA. They now face a potential rework of their entire technical file, delaying market entry by over a year and adding unexpected six-figure costs. We discuss how to avoid this trap.
This Episode's Key Questions:
- How will ANVISA's new SaMD regulation impact AI and machine learning devices?
- Is mandatory MDSAP participation a certainty for Brazil, and what is the deadline to prepare?
- What are the three key documents you need to update in your technical file for the new software rules?
- How can you leverage your existing certifications to streamline the new Brazilian requirements?
- What is the number one mistake foreign manufacturers make when interpreting ANVISA's agenda?
- Will the validity of Good Manufacturing Practices certificates finally be extended to align with product registrations?
At Pure Global, we specialize in turning these regulatory challenges into market opportunities. With our local experts in Brazil and advanced AI tools, we streamline the entire market access process, from regulatory strategy and technical dossier preparation to acting as your official in-country representative. Don't let regulatory hurdles block your entry into one of the world's largest MedTech markets. Contact us at [email protected] or visit https://pureglobal.com to secure your market presence.
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By Ran ChenBrazil's health agency, ANVISA, has just unveiled its ambitious 2026-2027 regulatory agenda, signaling one of the most significant shifts in the Latin American MedTech landscape in years. This isn't just a minor update; it's a fundamental move towards stricter, globally harmonized standards that will redefine market access.
This episode of LATAM MedTech Insights dives deep into the two most critical changes: a complete overhaul of the rules for Software as a Medical Device (SaMD) and the game-changing proposal to make MDSAP audits mandatory for all manufacturers. We break down the immediate operational and strategic impact these changes will have on your business.
A US-based digital health startup just received FDA clearance for its AI-powered diagnostic tool. They saw Brazil as their next big market, but the planned revision of RDC 657 means their existing validation data might be insufficient for ANVISA. They now face a potential rework of their entire technical file, delaying market entry by over a year and adding unexpected six-figure costs. We discuss how to avoid this trap.
This Episode's Key Questions:
- How will ANVISA's new SaMD regulation impact AI and machine learning devices?
- Is mandatory MDSAP participation a certainty for Brazil, and what is the deadline to prepare?
- What are the three key documents you need to update in your technical file for the new software rules?
- How can you leverage your existing certifications to streamline the new Brazilian requirements?
- What is the number one mistake foreign manufacturers make when interpreting ANVISA's agenda?
- Will the validity of Good Manufacturing Practices certificates finally be extended to align with product registrations?
At Pure Global, we specialize in turning these regulatory challenges into market opportunities. With our local experts in Brazil and advanced AI tools, we streamline the entire market access process, from regulatory strategy and technical dossier preparation to acting as your official in-country representative. Don't let regulatory hurdles block your entry into one of the world's largest MedTech markets. Contact us at [email protected] or visit https://pureglobal.com to secure your market presence.