Pure Global: Brazil's New SaMD Hurdle & The Hidden AI Challenge

This week, we dissect a game-changing regulatory update from Brazil's ANVISA that directly impacts AI-powered medical devices. Brazil has introduced a mandatory "Algorithm Change Protocol" for all Software as a Medical Device (SaMD), creating a new, complex layer of requirements that surpasses current FDA and EU standards. This change is already causing submission delays for unprepared companies. We explore what this new protocol entails, why ANVISA is taking this assertive step, and what it means for your LATAM market access strategy. This episode provides essential insights for any MedTech manufacturer looking to launch AI-driven technologies in Latin America's largest market. Don't let this unexpected hurdle derail your expansion plans. **Key Questions Answered:** * What is the new "Algorithm Change Protocol" that ANVISA now requires for all AI-based SaMD? * Why is your existing FDA or CE-marked technical file suddenly insufficient for Brazil? * How does this update specifically impact SaMD for diagnostic imaging versus therapeutic applications? * What are the immediate costs and timeline delays if this protocol is missing from your submission? * How can you proactively build this protocol into your Quality Management System? * Is this a sign of a broader regulatory trend across other LATAM countries? * What are the top three mistakes companies make when trying to meet these new AI documentation rules? At Pure Global, we specialize in navigating these complex and evolving regulatory landscapes. Our team of local experts, powered by advanced AI tools, provides end-to-end solutions to get your MedTech and IVD products to market efficiently. From developing a robust regulatory strategy and compiling technical dossiers to acting as your official in-country representative, we streamline your access to over 30 global markets, including Brazil. Don't let regulatory surprises slow you down. Contact us at [email protected] or visit https://pureglobal.com to learn more.