LATAM MedTech Insights

Mexico's MedTech market is buzzing with the news of COFEPRIS's new fast-track approval pathway, promising quicker market access for devices with existing international approvals. This move positions Mexico as a key entry point into Latin America, attracting significant global interest. However, beneath this promising headline lies a complex new reality. The updated regulations include stringent new requirements for AI-driven software and connected devices, focusing heavily on cybersecurity and local data privacy laws. Many companies, eager to leverage the fast-track system, are being caught off guard, leading to unexpected rejections and costly delays. This episode unpacks the hidden complexities of Mexico's new regulatory landscape. A prime example is a European AI diagnostics company. They eagerly submitted their CE-marked product for the new fast-track approval, only to be rejected for failing to meet Mexico's specific cybersecurity and data protection standards, which were not part of their original technical file. This misstep has cost them a projected six-month delay and significant rework costs. Key questions answered in this episode: - What are the specific new cybersecurity requirements COFEPRIS is now demanding for SaMD? - How can you leverage your existing FDA or CE approval while avoiding common pitfalls in the new Mexican system? - Why is compliance with Mexico's personal data protection law a new critical point for dossier submission? - What's the biggest mistake companies are making when applying for the new fast-track registration? - How can you conduct a gap analysis to ensure your technical file is ready for these new standards? - Are there new labeling requirements for AI-powered devices under this framework? - What kind of post-market surveillance is required for software that uses machine learning? At Pure Global, we specialize in navigating these complex regulatory shifts. We offer end-to-end solutions for MedTech and IVD companies, combining local expertise in markets like Mexico with advanced AI tools to streamline global market access. Whether it's developing a new regulatory strategy, compiling a compliant technical dossier, or acting as your local representative, we turn regulatory hurdles into market opportunities. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.

This week, we dive into a sudden and seismic regulatory shift in Argentina. ANMAT's newly issued Resolution 785/2025 has introduced strict data localization and cybersecurity audit requirements for all Software as a Medical Device (SaMD) and connected devices, sending shockwaves through the industry. This episode breaks down the immediate implications for foreign manufacturers, who now face a tight 180-day deadline to overhaul their data infrastructure. We explore the strategic challenges posed by this new regulation, from the technical complexities of data migration to the uncertainty surrounding the list of approved local auditors. This is a must-listen for any MedTech company operating in or planning to enter the Argentinian market, providing a clear-eyed look at the new reality of digital protectionism in Latin America and what it takes to maintain compliance and market access. A specific case we discuss involves a leading European AI radiology software provider. Their platform relies on centralized servers in Brazil, and they now face the daunting and costly task of migrating their entire operation to a local Argentinian data center within 180 days. This unexpected mandate threatens to disrupt their services for existing hospital clients and could derail their growth strategy in the region. Key questions for this episode: - What are the exact requirements of ANMAT's new Resolution 785/2025? - How does the data localization mandate impact cloud-based SaMD and IoT devices? - What are the first three steps your company must take to assess its compliance risk? - Why are even well-established products with existing registrations in Argentina at risk? - How can you find and qualify a local data hosting partner that meets ANMAT's new stringent standards? - What specific cybersecurity documentation must be added to your technical dossier for submission? - Is this new Argentinian rule a blueprint for future regulations in other major LATAM markets? Struggling with sudden regulatory shifts in LATAM? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. From acting as your local representative in Argentina to developing a new regulatory strategy for data compliance, we ensure you maintain your market presence without disruption. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.

This week, we dissect a game-changing regulatory shift in Latin America's largest market. Brazil's ANVISA has just proposed a new fast-track approval process for AI-driven medical software, promising to slash market entry timelines for devices already approved by agencies like the FDA. But a closer look reveals a complex new challenge that could catch even the most prepared companies off guard. Imagine you're a global MedTech company with an FDA-cleared diagnostic AI. You see the 'fast-track' news from Brazil and plan for a quick launch. But your planned submission is suddenly non-compliant, citing a new, demanding annex on data traceability and cybersecurity specific to the Brazilian population that your initial regulatory package never accounted for. This is the hidden reality companies will now face. What you'll learn in this episode: - What is ANVISA's new proposed fast-track for AI medical devices? - Why is the new data governance requirement a hidden barrier for foreign manufacturers? - How do these proposed Brazilian rules differ from standard FDA or Health Canada requirements? - Could this 'fast-track' pathway actually delay market entry for unprepared companies? - What immediate steps should you take to assess your AI's training data for compliance? - Which specific local data protection protocols (LGPD) are now integrated into regulatory clearance? - How can this change be leveraged to build a stronger, more defensible market position in Brazil? Don't let regulatory surprises derail your LATAM expansion. Pure Global offers end-to-end regulatory consulting, combining local expertise with advanced AI tools to streamline market access in Brazil and over 30 other markets. We help you navigate complex changes like ANVISA's new AI rules, ensuring your technical dossier is compliant from day one. Contact us at [email protected] or visit https://pureglobal.com/ to secure your market presence.

This week, we dissect a game-changing regulatory shift in Latin America's largest market. Brazil's ANVISA has just launched a new resolution for Software as a Medical Device (SaMD), creating an unprecedented fast-track pathway for innovative digital health products. This move promises to slash approval times and attract global investment. But there's a catch. While the new "fast-track" leverages existing international approvals, it also imposes stricter, more sophisticated requirements on technical documentation, cybersecurity, and clinical data relevance for the Brazilian population. This episode explores how savvy MedTech companies can seize this opportunity while avoiding the hidden pitfalls that could lead to rejection. **Case Study:** A European AI-driven diagnostic software company, already holding a CE mark, has been planning its entry into Brazil. The new ANVISA resolution seems like a golden ticket to bypass the historically long review times. But will their existing technical file be enough? Are their cybersecurity protocols compliant with Brazil's specific data laws? We break down the critical gaps they must fill to turn this opportunity into a market reality. **Key Questions Answered:** - What are the specific criteria to qualify for ANVISA's new SaMD fast-track pathway? - How can you leverage your existing FDA or CE marking approval for a faster Brazilian registration? - What are the top three new documentation requirements that most companies will overlook? - Why is adapting your clinical data to Brazilian demographics now non-negotiable? - What specific cybersecurity vulnerabilities is ANVISA now scrutinizing more than ever? - How has the role of the Brazil Registration Holder (BRH) evolved from a legal requirement to a strategic necessity? Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. Contact Pure Global at [email protected] or visit us at https://pureglobal.com/.

Last week, Brazil's ANVISA unleashed a pivotal update for Software as a Medical Device (SaMD) with its new resolution, RDC 992/2025. While appearing to align with international standards, this new regulation introduces complex cybersecurity and data privacy requirements tied specifically to Brazil's LGPD law, creating unexpected hurdles for global manufacturers. In this episode of LATAM MedTech Insights, we dissect the fine print of ANVISA's new rules. We explore the immediate operational impacts, from mandatory local data protection officers to new clinical data requirements for AI-driven software, and discuss the strategic adjustments companies must make to maintain or gain market access in Latin America's largest market. Case Study: Imagine you're a US-based scaleup with a groundbreaking AI diagnostic tool. Your EU MDR and FDA clearances are in hand, and Brazil is your next target. Suddenly, your registration is stalled. Why? Your application didn't address specific LGPD data transfer protocols and your designated data officer isn't based in Brazil. This is the new reality—a costly and time-consuming roadblock that a standard regulatory checklist would have missed. Key Takeaways: 1. What are the three 'hidden' requirements in ANVISA's new SaMD rule that most foreign companies will miss? 2. How does Brazil's LGPD law now directly impact your medical device's technical file? 3. Is your current cybersecurity plan sufficient for the new Brazilian standards? 4. Why might your existing AI/ML validation data be rejected by ANVISA? 5. What's the new mandatory role you might need to hire in Brazil to keep your SaMD on the market? 6. How does this update affect legacy SaMD products already registered in Brazil? 7. What are the critical deadlines you cannot afford to ignore over the next six months? Navigating the evolving regulatory landscape in Latin America requires more than just a checklist; it demands localized, expert strategy. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies, combining deep local expertise with advanced AI tools to streamline your global market access. We act as your local representative, manage your technical dossier, and ensure continuous compliance. Don't let regulatory surprises derail your expansion. Contact us at [email protected] or visit https://pureglobal.com/ to secure your market presence.