『Pure Global: Brazil's SaMD Surprise—Decoding ANVISA's Hidden Cybersecurity Rules』のカバーアート

Pure Global: Brazil's SaMD Surprise—Decoding ANVISA's Hidden Cybersecurity Rules

Pure Global: Brazil's SaMD Surprise—Decoding ANVISA's Hidden Cybersecurity Rules

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概要

 Brazil's digital health market is booming, but a recent regulatory update from its agency, ANVISA, has changed the rules of the game for 2026. The new guidance for Software as a Medical Device (SaMD) goes far beyond basic registration, introducing stringent cybersecurity and lifecycle management requirements that are catching many international companies off guard. In this episode, we break down what these changes mean for you. We explore why your existing FDA or CE Mark documentation is no longer sufficient for Brazil and how adapting to these new rules can become your key competitive advantage in Latin America's largest market. **Case Study:** Imagine your company has a cutting-edge AI diagnostic tool, ready to conquer the Brazilian market. You’ve prepared your clinical data, but you suddenly face a rejection because your submission lacks a detailed cybersecurity vulnerability report adapted to Brazil's data privacy laws (LGPD). This unexpected roadblock could delay your launch by over a year, allowing local competitors to capture the market first. Are you prepared for this new reality? **Key questions answered in this episode:** * What specific cybersecurity standards has ANVISA recently mandated for SaMD? * How can you leverage your existing technical file for a successful Brazilian submission? * What are the three most common pitfalls for foreign firms under the new guidelines? * Why is post-market surveillance now as critical as the initial registration? * How does Brazil's new framework signal a larger regulatory trend across LATAM? * What is the crucial first step to take before submitting your digital health product to ANVISA? At Pure Global, we specialize in demystifying these complex regulatory landscapes. Our local experts in Brazil, combined with our AI-driven data tools, provide end-to-end support for your MedTech and IVD products. We transform regulatory hurdles into market opportunities. Ready to accelerate your entry into Brazil? Contact us at info@pureglobal.com or visit https://pureglobal.com/.
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