In this episode of LATAM MedTech Insights, we dissect the complex world of SaMD registration in Brazil. We go beyond the surface-level question of certifications and explore the strategic nuances that can define your success in Latin America's largest market. We explain why simply having an ISO 13485 certificate, the global standard for quality management, is not enough to get your software approved by ANVISA. We uncover the critical role of Brazilian Good Manufacturing Practices (BGMP) and reveal how the Medical Device Single Audit Program (MDSAP) can be your most powerful tool. Learn how leveraging MDSAP can slash your time-to-market from years to months, giving you a significant competitive advantage. Imagine you've developed a groundbreaking AI diagnostic tool. You have your ISO 13485 certificate and are ready to launch in Brazil. You submit to ANVISA, only to be told the wait for a mandatory quality system inspection is over two years long. Your entire commercialization plan is on hold. Meanwhile, your competitor, who also has ISO 13485 but strategically invested in an MDSAP certification, uses it to bypass the inspection queue. They are on the market in six months, capturing key clients while you are still waiting. This episode tells you how to be the competitor who wins. This episode's key takeaways: - Why is an ISO 13485 certificate insufficient for your ANVISA SaMD submission? - What exactly is Brazilian BGMP and which device classes require certification before market entry? - How can the MDSAP program reduce your time-to-market in Brazil by over 18 months? - Are lower-risk SaMD exempt from quality system requirements in Brazil? - What is the difference between a *notificação* and a *registro* pathway for SaMD? - Which specific Brazilian regulation, RDC 657/2022 or RDC 751/2022, governs your software's requirements? - How does a weak regulatory strategy create a two-year competitive disadvantage? At Pure Global, we specialize in turning regulatory hurdles into market opportunities. We offer end-to-end regulatory consulting for MedTech and IVD companies, combining local LATAM expertise with advanced AI tools to streamline your global market access. Let us be your local representative and build the most efficient regulatory pathway for your technology. Contact us at [email protected] or visit https://pureglobal.com/.