This episode of LATAM MedTech Insights dives into a critical question for innovators: How does Argentina's regulatory authority, ANMAT, handle artificial intelligence and machine learning in medical devices? We cut through the ambiguity to reveal that while there isn't a specific AI-only regulation, these products are actively regulated under the existing robust framework for Software as a Medical Device (SaMD). We explore the practical steps for registering an AI-powered device in Argentina, from the crucial risk classification process to the detailed requirements for your technical dossier. Using the example of an AI tool for diagnostic imaging, we illustrate the challenges and necessities, such as providing extensive algorithm validation data and the mandatory appointment of a local Argentina Registration Holder. This episode provides a clear roadmap for companies looking to enter this key LATAM market with cutting-edge technology. Key Takeaways: * What is the current official stance of ANMAT on regulating AI-specific medical devices? * How does Argentina's four-tier risk classification system apply to Software as a Medical Device? * What are the essential components of a technical dossier for an AI algorithm submitted to ANMAT? * Why is appointing an Argentina Registration Holder a non-negotiable step for foreign manufacturers? * What is the role of the IMDRF in shaping the future of AI medical device regulation in Argentina? * How can you prove the safety and efficacy of a "black box" machine learning algorithm to regulators? * What are the most common pitfalls to avoid when submitting an advanced software device for approval in Argentina? At Pure Global, we specialize in demystifying complex regulatory landscapes. We offer end-to-end solutions for MedTech and IVD companies, combining local expertise in over 30 markets with advanced AI tools to streamline your global market access. Let us be your local representative and strategic partner in Latin America and beyond. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.