Brazil's AI MedTech Shake-Up: Pure Global on Cracking ANVISA's New Cybersecurity Code cover art

Brazil's AI MedTech Shake-Up: Pure Global on Cracking ANVISA's New Cybersecurity Code

Brazil's AI MedTech Shake-Up: Pure Global on Cracking ANVISA's New Cybersecurity Code

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 This week, we dive into a major regulatory shift in Brazil that's sending shockwaves through the digital health sector. ANVISA, the national health surveillance agency, has just released RDC 899, a groundbreaking resolution that imposes stringent new cybersecurity and data privacy rules for all Software as a Medical Device (SaMD). This update creates immediate challenges for MedTech companies, especially those leveraging AI and machine learning. The resolution requires deep integration with Brazil's data protection laws (LGPD) and demands unprecedented transparency into algorithm validation. We break down the core components of RDC 899 and what they mean for your products, whether you're seeking new registration or preparing for a renewal. A European AI diagnostics company, with a device already successful in the Brazilian market, is now facing a critical challenge. Their upcoming registration renewal requires them to retroactively create an entire cybersecurity risk portfolio and provide detailed validation data for their proprietary algorithms. This unexpected task threatens to delay their renewal, potentially costing them millions in revenue and market position. How can you avoid this costly pitfall? Key Takeaways This Episode: * What are the three mandatory documents now required under ANVISA's RDC 899? * How does Brazil's data protection law, the LGPD, now directly impact your SaMD's software architecture? * For AI-driven devices, what specific information about your training datasets must now be submitted to ANVISA? * What is the immediate risk for devices that are already registered and approaching their renewal date? * How can you turn this new regulatory hurdle into a competitive advantage in the Brazilian market? * What are the unwritten expectations from ANVISA when reviewing these new cybersecurity files? Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI and data tools to streamline global market access. We act as your local representative in over 30 markets, including Brazil, ensuring you can navigate complex changes like RDC 899 without delaying your growth. Don't let regulatory surprises derail your launch. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your market presence.
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