In this episode of LATAM MedTech Insights, we explore the significant regulatory shift in Mexico concerning AI-powered medical software. Mexico's health authority, COFEPRIS, has updated its framework, moving away from treating software as a simple accessory to classifying it as a regulated medical device in its own right. This change is crucial for any MedTech company aiming to penetrate the vibrant Mexican market. We break down the new risk-based classification system—Class I, II, and III—and discuss how the intended use of your AI software determines its regulatory pathway. This episode provides essential information for developers and manufacturers, ensuring they understand the new rules of engagement to avoid costly delays and rejections. Case Study Spotlight: Imagine spending years developing a revolutionary AI tool that predicts cardiac risk from a selfie, only to have your market entry blocked by regulatory confusion. We examine the success story of Medsi AI, a company that successfully navigated the new COFEPRIS guidelines to get their AI-powered diagnostic platform approved as a Class II medical device, setting a vital precedent for the industry. Key Takeaways: - Why did COFEPRIS fundamentally change its regulations for Software as a Medical Device (SaMD)? - What are the specific criteria for Class I, II, and III risk classifications in Mexico? - How does my AI software's intended use directly impact its classification and submission requirements? - What key documentation was crucial for Medsi AI to secure its Class II approval? - Can I leverage my existing FDA or CE marking for an expedited review with COFEPRIS? - What are the most common pitfalls to avoid when submitting an AI SaMD application in Mexico? - How will this regulatory shift impact the future of digital health innovation in Latin America? Navigating the complex regulatory landscape of Latin America is our expertise. Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline your global market access. For a clear and efficient pathway into markets like Mexico, contact us at [email protected] or visit https://pureglobal.com/.