Episodios

  • Brazil's SaMD Cybersecurity Shockwave: Pure Global on ANVISA's Hidden Demands.

    Brazil's SaMD Cybersecurity Shockwave: Pure Global on ANVISA's Hidden Demands.
    Dec 17 2025
    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 info@pureglobal.com or visit https://pureglobal.com/ to secure your market presence.
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    2 m
  • Brazil's MDR Surprise: ANVISA's Hidden Clause for MedTech Imports | Pure Global

    Brazil's MDR Surprise: ANVISA's Hidden Clause for MedTech Imports | Pure Global
    Dec 16 2025
    This week, we dissect the immediate fallout from ANVISA's surprise regulatory shift in Brazil. While the move towards EU MDR alignment was expected, a hidden clause mandating local usability studies for high-risk devices has caught many international MedTech firms by surprise, threatening to delay launches and inflate budgets. We explore the specifics of the new RDC 987/2025 resolution and what it means for companies who previously relied on their CE marking for a smoother entry into Latin America's largest market. This episode is a must-listen for regulatory affairs professionals, product managers, and executives focused on global expansion. A leading German cardiac stent company had its Brazilian launch plan finalized, with its budget approved and timeline set. Last week’s ANVISA announcement instantly invalidated their strategy. Now, they're facing an unexpected nine-month delay and an unbudgeted six-figure cost for a mandatory local study they never saw coming. Key questions from this episode: - Does ANVISA's new rule make your existing technical file obsolete for Brazil? - What are the hidden costs and timeline impacts of the mandatory in-country usability studies? - How can you leverage your existing data to potentially streamline this new local requirement? - Could this regulatory shift in Brazil signal a trend for other LATAM markets? - Is your local representative in Brazil equipped to manage these new complex clinical requirements? - What steps should you take today to de-risk your 2026 LATAM launch plans? Navigating sudden regulatory changes requires deep local expertise and a proactive strategy. At Pure Global, we offer end-to-end regulatory consulting, acting as your local representative in over 30 markets, including Brazil. We use advanced AI and data tools combined with on-the-ground expertise to streamline global market access and ensure you're always ahead of the curve. Don't let regulatory surprises derail your growth. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your market presence.
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    2 m
  • Brazil's ANVISA AI Gambit: Pure Global on Hacking the MedTech Approval Backlog.

    Brazil's ANVISA AI Gambit: Pure Global on Hacking the MedTech Approval Backlog.
    Dec 15 2025
    Last week, Brazil's regulatory agency, ANVISA, unveiled a groundbreaking 2025 plan to tackle its notorious medical device approval backlogs. The initiative, named "AnvisAI," leverages artificial intelligence to create an automated fast-track system for lower-risk devices, aiming to cut review times by more than half and reshape the market access landscape. This move signals a major shift, potentially transforming Brazil from one of the most challenging LATAM markets into a hub for MedTech innovation. This episode unpacks the details of the AnvisAI project, exploring what it means for manufacturers' regulatory strategies and the immediate opportunities it creates for faster market entry. We explore a critical case study: Imagine launching an innovative Software as a Medical Device (SaMD) and facing a 24-month approval delay, tying up capital and stalling growth. ANVISA's new AI-driven pathway could slash that wait time to just a few months, completely changing the financial and strategic calculus for entering Brazil. Key Takeaways: 1. What exactly is the "AnvisAI" project and how will it re-classify devices for the new fast-track? 2. Which specific device classes stand to benefit the most from automated approvals? 3. What are the hidden data and documentation requirements for submissions to the new AI system? 4. How does this decision position Brazil against other LATAM markets like Mexico and Colombia? 5. What are the immediate actions MedTech companies should take to adapt their registration strategy? 6. Will this new system require changes to post-market surveillance and vigilance reporting? 7. How does this initiative align with Brazil's broader National AI Strategy? Navigating Brazil's rapidly evolving regulatory landscape requires local expertise and advanced technological tools. At Pure Global, we offer end-to-end regulatory consulting solutions, combining on-the-ground experts in Brazil with proprietary AI tools to streamline your market access. From regulatory strategy and dossier preparation to acting as your local representative, we help you leverage these new opportunities for faster growth. To learn how we can accelerate your entry into the Brazilian market, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 m
  • Pure Global: Brazil's MedTech Leap to Digital - The Hidden Compliance Traps.

    Pure Global: Brazil's MedTech Leap to Digital - The Hidden Compliance Traps.
    Dec 14 2025
    This week, we dissect a major regulatory shake-up in Latin America's largest MedTech market: Brazil. ANVISA, the national health surveillance agency, has just initiated a pivotal shift from paper to digital, while simultaneously revoking its traceability regulations. This move promises to cut costs and streamline logistics for manufacturers but introduces a new host of digital compliance and supply chain challenges. We explore how this digital-first policy impacts a device manufacturer's entire operational playbook overnight. Imagine being able to update a user manual with a single click instead of recalling thousands of product kits. This episode details the immediate opportunities and the hidden risks, from ensuring digital access in rural clinics to addressing new cybersecurity threats. Key Takeaways From This Episode: - How does Brazil's new digital leaflet policy impact my product launch timeline? - What are the hidden cybersecurity risks of shifting to digital-only documentation? - ANVISA revoked traceability rules, so what does this mean for my supply chain integrity? - Is this digital trend isolated to Brazil, or is it spreading across LATAM? - How can I update my Quality Management System to handle digital compliance? - What new software and validation processes are now required? - Does this change affect my existing product registrations or do I need to re-submit? Navigating these rapid shifts is where Pure Global excels. We offer end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise with advanced AI to streamline market access. Don't let regulatory changes disrupt your strategy. Contact Pure Global at info@pureglobal.com or visit us at https://pureglobal.com/ for a consultation.
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    2 m
  • São Paulo SaMD Shake-Up: Pure Global on ANVISA’s Unwritten Rules for AI

    São Paulo SaMD Shake-Up: Pure Global on ANVISA’s Unwritten Rules for AI
    Dec 13 2025
    Brazil's MedTech landscape is buzzing as its regulatory agency, ANVISA, puts Software as a Medical Device (SaMD) back under the microscope. In its newly released 2024-2025 agenda, ANVISA has signaled major revisions to the existing framework, a move that comes sooner than many in the industry expected. This suggests that the initial guidelines are already being outpaced by rapid advancements in digital health, especially in AI and machine learning. This episode dives deep into the implications for MedTech manufacturers. While Brazil's alignment with international standards has created opportunities, navigating the specifics of its regulatory environment remains a complex challenge. For companies with innovative SaMD, particularly those leveraging adaptive AI, the upcoming changes could mean the difference between market leadership and costly compliance failures. We explore what these revisions might entail and how companies can prepare for a more stringent regulatory future. A real-world example: A US-based scaleup has a powerful AI-driven diagnostic platform. Their biggest pain point is regulatory ambiguity. They are uncertain if their adaptive algorithm fits ANVISA's current risk classification and are struggling to prepare cybersecurity documentation that will satisfy local requirements, which differ from those of the FDA. This uncertainty is delaying their entry into one of LATAM's largest markets, costing them valuable time and revenue. What you'll learn in this episode: 1. Why is ANVISA revisiting its SaMD regulations so soon after the 2022 framework was established? 2. What are the three key areas, including AI and cybersecurity, likely to see the strictest new rules? 3. How does Brazil's approach to classifying adaptive AI software differ from the EU or US? 4. What are the most common documentation gaps that lead to SaMD registration delays in Brazil? 5. Is your current change control process robust enough for ANVISA's evolving expectations? 6. How can you leverage your existing international technical files for a faster Brazilian submission? 7. What are the unspoken post-market surveillance challenges unique to digital health in LATAM? 8. How do you determine if a software update is a minor change or requires a completely new registration? Ready to streamline your market access in Brazil and beyond? Pure Global offers end-to-end regulatory consulting solutions, combining local expertise with advanced AI to accelerate your success. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can be your local partner for global growth.
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    3 m
  • Pure Global LATAM Insights: Brazil's SaMD Shakeup - Decoding ANVISA's 2025 Digital Health Playbook.

    Pure Global LATAM Insights: Brazil's SaMD Shakeup - Decoding ANVISA's 2025 Digital Health Playbook.
    Dec 12 2025
    Brazil's regulatory agency, ANVISA, is updating its rules for Software as a Medical Device (SaMD) as a key priority for 2025. This major overhaul will align Brazil’s digital health landscape with global standards like the EU MDR, introducing stricter requirements for cybersecurity, interoperability, and technical documentation. This change presents a critical challenge for MedTech innovators. For example, a US-based AI diagnostics company eager to enter the lucrative Brazilian market now faces new, complex questions. How can they ensure their existing cybersecurity protocols meet ANVISA's new, currently undefined standards? The fear of a delayed or rejected submission due to non-compliance with these evolving rules could stall their entire LATAM expansion strategy, making proactive guidance essential. Key Takeaways: 1. How will ANVISA's new SaMD framework specifically align with the EU's MDR, and what does this mean for documentation? 2. What new cybersecurity and data privacy requirements must your software meet to gain approval in Brazil? 3. Will the updated regulations create a faster or more complex path to market for digital health startups? 4. What specific changes to Instructions for Use (IFU) will be mandatory for all SaMDs? 5. How can you prepare your technical dossier now for the anticipated 2025 changes? 6. What are the new expectations for demonstrating software interoperability with existing hospital systems? 7. How will the risk classification for SaMDs change under the new Brazilian framework? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. We act as your local representative, develop efficient regulatory strategies, and use AI to compile and submit technical documents. Contact Pure Global at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 m
  • Pure Global: Brazil's MedTech Data Shock - ANVISA's New Cybersecurity Surprise

    Pure Global: Brazil's MedTech Data Shock - ANVISA's New Cybersecurity Surprise
    Dec 11 2025
    Last week, Brazil's ANVISA implemented a sudden and strict new regulation for cybersecurity in connected medical devices. This unexpected move introduces mandatory data localization, forcing companies to store Brazilian patient data on servers within the country, creating significant technical and financial hurdles for global manufacturers. This episode of LATAM MedTech Insights unpacks the immediate impact of this new rule. We explore the specific technical requirements, the short 90-day compliance window, and what this means for companies with existing products in the market or those planning to enter Brazil's lucrative MedTech space. Imagine your state-of-the-art, cloud-powered diagnostic device, already approved in Europe and the US, is suddenly blocked from the Brazilian market. The reason is ANVISA's new data localization law, passed just last week, which makes your global cloud architecture non-compliant overnight. This is the urgent new reality facing MedTech innovators in Brazil. Key questions from this episode: - What are the three critical actions you must take to comply with ANVISA's new cybersecurity note? - How does the mandatory data localization rule affect your existing global cloud strategy? - Are there any exemptions for small-scale startups or SaMD products? - What specific encryption standards are now mandatory, and which are obsolete? - How can you update your technical dossier to prevent import delays and rejections? - What does this shift signal for the rest of the Latin American market? Is your business ready to navigate sudden regulatory shifts in Latin America? At Pure Global, we offer end-to-end solutions to ensure your MedTech and IVD products meet complex local requirements. From developing a robust regulatory strategy and compiling technical dossiers with our AI-powered tools to acting as your official local representative, we streamline your path to market access. Don't let regulatory surprises derail your expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can secure your market presence in over 30 countries.
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    2 m
  • Brazil's AI MedTech Leap: Pure Global on Cracking ANVISA's New SaMD Code

    Brazil's AI MedTech Leap: Pure Global on Cracking ANVISA's New SaMD Code
    Dec 10 2025
    Brazil's regulatory agency, ANVISA, has just redefined the future of digital health in Latin America with its new, comprehensive framework for AI-powered Software as a Medical Device (SaMD). This landmark regulation introduces a stricter risk classification system and new requirements for algorithm validation and cybersecurity, directly impacting any MedTech company looking to enter or grow in the region's largest market. This episode of LATAM MedTech Insights provides a crucial analysis of these changes. We uncover what the new four-tiered risk system means for your product, how to manage the lifecycle of your AI algorithms under the new rules, and why aligning with Brazil's data privacy laws is now more critical than ever. This isn't just a regulatory update. it's a strategic shift that will influence the entire LATAM region. **Case Study:** Imagine your AI-powered diagnostic tool, which has been operating in a regulatory gray area, is suddenly reclassified as a high-risk device under the new ANVISA framework. You now face urgent demands for more extensive clinical data, a formal algorithm change protocol, and stricter cybersecurity measures, potentially delaying your market access by months. Are you prepared to meet this new, higher standard. **Key Takeaways:** * What are the most significant changes in ANVISA's new SaMD regulation. * How does Brazil's new AI framework compare to the FDA and EU MDR standards. * Why might your SaMD's risk classification change overnight in Brazil. * What specific cybersecurity vulnerabilities is ANVISA now targeting. * Has the Brazilian market become more challenging or more predictable for foreign SaMD companies. * How will this decision impact regulatory trends in other LATAM markets like Mexico and Colombia. * What are the immediate next steps your regulatory team must take to ensure compliance. Navigating these regulatory shifts requires local expertise and a global strategy. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, using advanced AI and data tools to streamline global market access. We help you turn regulatory complexity into a competitive advantage. To secure your position in the evolving Latin American market, contact us at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 m