『Pure Global: Brazil's AI Medical Software Rules - ANVISA's Surprise Roadblock.』のカバーアート

Pure Global: Brazil's AI Medical Software Rules - ANVISA's Surprise Roadblock.

Pure Global: Brazil's AI Medical Software Rules - ANVISA's Surprise Roadblock.

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概要

 This week, we dive into a sudden and impactful regulatory shift in Brazil. ANVISA, the country's health agency, released a new resolution last week that specifically targets Software as a Medical Device (SaMD), creating significant new hurdles for manufacturers, especially those using AI and machine learning. This update introduces stringent cybersecurity protocols, challenging data localization laws, and a more rigid process for software updates. We explore what these changes mean on the ground through a practical case study. A U.S. diagnostics company, on the verge of launching its FDA-cleared AI cardiac software in Brazil, now finds its entire market entry strategy jeopardized by these new rules. Their reliance on U.S.-based cloud servers and agile development cycles directly conflicts with ANVISA's new mandates, forcing them to consider a costly strategic pivot or abandon the market. Key Takeaways: - What are the three core pillars of ANVISA's new SaMD regulation announced last week? - Why is the new data sovereignty rule a major obstacle for global MedTech companies? - How does the updated change control process impact companies using agile development? - What specific cybersecurity standards are now mandatory for software devices in Brazil? - Can you still leverage your FDA or CE marking for an expedited review under these new rules? - What is the first step you should take if your product is affected by this sudden change? Navigating the complexities of LATAM's regulatory environment is critical for success. At Pure Global, we offer 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. Whether you're dealing with new software regulations in Brazil or planning a multi-market launch, we provide the strategic guidance and in-country representation you need. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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