Episodi

  • Pure Global: Brazil's 3D-Printed MedTech Scramble - Inside ANVISA's Surprise Rule Shake-up.

    Pure Global: Brazil's 3D-Printed MedTech Scramble - Inside ANVISA's Surprise Rule Shake-up.
    Jan 22 2026
    Brazil's regulatory agency, ANVISA, has just released a surprise draft guidance for personalized, 3D-printed medical devices, sending shockwaves through the MedTech industry. With a very short 30-day window for public feedback, international companies are now scrambling to understand the complex new rules for software validation and data privacy that could disrupt their market access strategies. This episode dives deep into the specific challenges and hidden opportunities within this proposal. We analyze the potential requirement for Brazil-specific software validation, which may conflict with existing FDA or CE Mark approvals. We also unpack the ambiguous data localization clauses that could threaten the global operational models of many manufacturers. **Case Study Spotlight:** Imagine your company has perfected a workflow for creating patient-specific implants in a central European facility. You're on the verge of expanding into Brazil, but ANVISA's new rules could suddenly make your data transfer processes non-compliant, forcing a multi-million dollar investment in local infrastructure. Is your current regulatory strategy agile enough to handle this? **Key Questions Answered:** * Is ANVISA's 30-day feedback window a genuine consultation or a new barrier to entry? * What are the specific cybersecurity and data privacy risks hidden in the new draft? * How can you effectively challenge a proposed regulation that conflicts with your global model? * What are the unwritten rules for submitting feedback to ANVISA that actually gets considered? * Could Brazil's new framework for personalized devices set a new, complex standard for all of LATAM? Pure Global offers end-to-end regulatory consulting to help MedTech innovators navigate precisely these kinds of challenges. We combine local, in-country expertise with advanced AI tools to streamline global market access and ensure you're always ahead of regulatory changes. Don't let surprise regulations derail your expansion. Contact us at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 min
  • Pure Global: Brazil's SaMD Shift - Unpacking ANVISA's Hidden Hurdles for Foreign Tech

    Pure Global: Brazil's SaMD Shift - Unpacking ANVISA's Hidden Hurdles for Foreign Tech
    Jan 21 2026
    In this episode of LATAM MedTech Insights, we dissect the critical regulatory updates from Brazil's ANVISA that are reshaping the landscape for Software as a Medical Device (SaMD). This is not a minor tweak; it's a fundamental shift demanding that foreign manufacturers, especially in the AI and digital health sectors, rethink their entire market entry strategy. We explore the immediate implications of these new clarifications, focusing on the heightened demands for localized clinical data and the stringent requirements of Brazil's data privacy laws. This episode provides essential insights for any company looking to stay compliant and competitive in Latin America's largest and most complex market. **A Real-World Challenge:** Imagine you are a US-based scale-up with a revolutionary AI diagnostic tool, poised to enter the Brazilian market. Suddenly, you discover your extensive US and EU clinical data is deemed insufficient by ANVISA. You are now facing an unexpected, year-long delay to conduct local studies, jeopardizing your funding and first-mover advantage. How do you navigate this without derailing your entire LATAM launch? **Key Takeaways From This Episode:** * What specific clinical evidence is ANVISA now demanding for foreign SaMD? * How does Brazil's data privacy law (LGPD) impact your software's architecture? * Why is the risk classification for your AI-driven device more complex than you think? * What is the biggest mistake companies make when interpreting these new guidelines? * Could these stricter regulations hide unforeseen opportunities for well-prepared companies? * How can you leverage regulatory reliance pathways to potentially streamline this process? * What are the three essential questions to ask your local regulatory partner today? Pure Global offers 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. We help you turn regulatory hurdles into market opportunities. To learn more about navigating Brazil's evolving landscape or expanding into over 30 other global markets, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 min
  • Brazil's AI MedTech Surprise: Decoding ANVISA's New Rules with Pure Global

    Brazil's AI MedTech Surprise: Decoding ANVISA's New Rules with Pure Global
    Jan 20 2026
    This week, we dissect the breaking news from Brazil's regulatory landscape. ANVISA has just rolled out RDC 884, a new resolution that specifically targets AI and machine learning-powered medical software. This move signals a profound shift, moving Brazil away from reliance on foreign approvals and establishing a new, sophisticated framework for digital health technology. In this episode, we explore the critical details of this new regulation. We break down the stricter classification system, the controversial new requirements for localized clinical data, and the tough cybersecurity standards now being enforced. Learn what this means for MedTech innovators and how it will redefine the pathway to one of Latin America's largest markets. **Case Study:** Imagine you're a successful SaMD scale-up with FDA clearance, eyeing expansion. Your entire Brazilian market entry plan, built on leveraging your existing approvals, was just upended by ANVISA's announcement last week. Are you now required to run a costly and time-consuming local clinical trial? How do you prove your algorithm works for Brazil's unique population demographics? **This episode will answer:** - What are the three biggest changes in ANVISA's new AI software regulation? - Why might your existing FDA or CE Mark documentation now be rejected in Brazil? - Is a local clinical investigation mandatory for all AI-driven medical devices? - How can the new cybersecurity rules impact your product's architecture? - What are the hidden costs associated with the new data validation requirements? - Does this resolution create a new competitive advantage for locally-developed AI? - How should this change your strategic approach to the entire LATAM region? Struggling to keep up with regulatory shifts in Latin America? Pure Global offers end-to-end solutions for MedTech and IVD companies, combining local expertise with advanced AI tools to streamline global market access. Whether it's market strategy, local representation, or technical dossier submission, we make global expansion clear and efficient. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    2 min
  • Pure Global: Brazil's MedTech Renewal Ambush & ANVISA's Costly Registration Traps

    Pure Global: Brazil's MedTech Renewal Ambush & ANVISA's Costly Registration Traps
    Jan 19 2026
    This week, we dive into a silent but significant threat to MedTech companies in Brazil: the complexities of ANVISA's registration renewal process. Many manufacturers of Class I and II devices are unaware of the critical differences between a 'Notificação' and a 'Cadastro' approval, leading to a false sense of security. We explore how this simple misunderstanding can lead to the sudden cancellation of a product license, halting all sales and imports. This episode is a crucial guide for any company that wants to maintain its foothold and avoid the costly pitfalls of non-compliance in Latin America's largest market. **Case Study:** Imagine your company's Class II device has been successful in Brazil for nine years. Business is stable. Suddenly, you discover that your ANVISA registration is about to be cancelled permanently because your team missed the one-year deadline for the mandatory renewal application. Your entire Brazilian operation is now at risk from a single administrative oversight. **Key Questions from this Episode:** * Is your Brazilian device approval a one-time 'Notificação' or a time-limited 'Cadastro'? * Do you know the exact expiration date of your current ANVISA registration? * When is the final deadline to submit your renewal application before you risk cancellation? * What key documents are required for re-registration that weren't needed for the initial approval? * How can your local Brazil Registration Holder (BRH) fail to protect you from this risk? * Could this simple administrative mistake cost your company millions in lost revenue? * What is the first step to take today to audit your compliance status? Navigating the complexities of global markets is our expertise. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining local experts with advanced AI to streamline market access. From acting as your local representative to managing the entire submission and renewal process, we ensure your market presence is secure. Don't let regulatory surprises disrupt your business. Contact us for a consultation at info@pureglobal.com or visit https://pureglobal.com/.
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    2 min
  • Pure Global: Brazil's New SaMD Rules - Unseen Compliance Traps for Innovators.

    Pure Global: Brazil's New SaMD Rules - Unseen Compliance Traps for Innovators.
    Jan 18 2026
    Brazil is tightening its grip on the rapidly growing Software as a Medical Device (SaMD) market. A recent clarification from its regulatory agency, ANVISA, has introduced new, more stringent requirements for clinical evidence and cybersecurity, creating unexpected hurdles for global MedTech innovators. This move, aimed at increasing patient safety, could stall market entry plans for companies unprepared for this new level of scrutiny. This episode of LATAM MedTech Insights dives deep into what this new guidance practically means for manufacturers. We break down the specific documentation changes, analyze the strategic implications for companies targeting Brazil, and discuss the broader trend of increasing regulatory sophistication across Latin America. Case Study Spotlight: Imagine your cutting-edge diagnostic AI, already cleared in the US, is ready to launch in Brazil. Suddenly, ANVISA releases this new guidance demanding extensive local clinical data and cybersecurity protocols you don't have. Your launch is now stalled, and your investors are asking questions. This episode tackles that exact scenario. Key Takeaways in this Episode: * What are the three new documentation requirements for SaMD in Brazil that most companies will miss? * How does ANVISA's new cybersecurity expectation differ from the FDA's framework? * Is your existing clinical data from Europe or the US sufficient for a Brazilian submission now? * What specific local factors must be addressed in your risk management file for Brazil? * Could this new guidance actually create an advantage for companies that are prepared? * How will this impact the timeline and cost for registering a new SaMD product? At Pure Global, we specialize in demystifying complex regulatory landscapes. We offer end-to-end solutions for MedTech and IVD companies, leveraging local expertise and advanced data tools to streamline market access in over 30 countries, including Brazil. Don't let regulatory surprises derail your expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can help.
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    2 min
  • Pure Global: Brazil's MedTech Shift - Cracking ANVISA's New Digital Labyrinth.

    Pure Global: Brazil's MedTech Shift - Cracking ANVISA's New Digital Labyrinth.
    Jan 17 2026
    This week on LATAM MedTech Insights, we dive into the mandatory transition to ANVISA's new digital submission platform in Brazil. While the goal is to accelerate approvals, the reality is a wave of new, technical challenges stalling market access for many MedTech companies. We explore the hidden pitfalls of this digital shift, moving beyond traditional regulatory concerns to the critical importance of technical and IT compliance. Discover why perfectly valid clinical dossiers are being rejected for reasons like metadata errors and incompatible file formats, and what this means for your 2026 registration strategy. **Case Study Spotlight:** A European manufacturer of advanced diagnostic software had their Brazilian market entry delayed by over six months. Their clinically-sound dossier was rejected three times by ANVISA's new platform. The problem? Not their data, but undocumented digital formatting requirements. Find out what they were and how to avoid them. **Key Questions Answered:** * Why is ANVISA’s promise of faster digital approvals leading to unexpected delays? * What are the most common, yet undocumented, digital errors causing submission rejections? * How must you adapt your dossier preparation strategy for a digital-first review? * Is your current local partner in Brazil equipped to handle these new IT challenges? * What specific metadata is causing the most frequent mismatches in the new portal? * How can you pre-validate your submission package to avoid cryptic platform errors? * What is the true cost of a failed digital submission in terms of time and resources? Struggling to navigate the complexities of global market access? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We combine local expertise in over 30 markets, including Brazil, with advanced AI and data tools to streamline your registration and ensure compliance. Let us be your local representative and technical navigator. Contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 min
  • Pure Global: Brazil's AI MedTech Rush—Fast-Track or Data Privacy Trap?

    Pure Global: Brazil's AI MedTech Rush—Fast-Track or Data Privacy Trap?
    Jan 16 2026
    This week, we dissect a major regulatory shift in Latin America's largest market. Brazil's ANVISA has just launched RDC 987, a new fast-track approval process for AI-powered medical devices. While this promises to slash market entry timelines, it also introduces complex and unprecedented data privacy requirements tied to the LGPD. This episode explores the dual nature of this regulation. It is both a golden opportunity for tech-forward companies and a potential minefield of compliance. We uncover the hidden challenges that could stall even the most innovative products, turning a supposed shortcut into a costly detour. **Case Study:** Imagine a European AI diagnostics firm, ready to capitalize on Brazil's new fast-track lane. They've prepared their technical dossier, but their submission is suddenly halted. The reason? The patient data used to train their groundbreaking algorithm years ago doesn't meet Brazil's strict new LGPD-based anonymization rules. Their multi-million dollar expansion is now trapped in a web of data compliance they never anticipated. **Key Takeaways:** * What specific documentation is now required under ANVISA's RDC 987? * How can you verify if your AI's legacy training data meets Brazil's new LGPD standards? * Is the "fast-track" a genuine opportunity or a resource trap for non-local companies? * What are the legal liabilities and costs of appointing a local Data Privacy Representative? * Can you leverage your existing FDA or CE marking to simplify this new process? * What are the new post-market surveillance requirements for AI devices under this rule? * How will this change impact reimbursement and market adoption in Brazil? At Pure Global, we specialize in turning these regulatory complexities into clear market access strategies. With our deep local expertise in Brazil and our advanced AI-driven data tools, we help MedTech and IVD companies navigate regulations like RDC 987 efficiently. Our end-to-end solutions cover everything from initial regulatory strategy and technical dossier submission to serving as your official local and data representative. Don't let compliance hurdles block your expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn how we can streamline your entry into over 30 global markets.
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    2 min
  • Pure Global: Brazil's ANVISA Shockwave - Navigating the New Digital MedTech Registration Chaos.

    Pure Global: Brazil's ANVISA Shockwave - Navigating the New Digital MedTech Registration Chaos.
    Jan 13 2026
    In this episode, we dissect the sudden and disruptive launch of ANVISA's new mandatory digital submission platform in Brazil, which has caught many international MedTech manufacturers off guard. We explore the immediate operational challenges, from language barriers to technical glitches, and discuss the strategic implications for companies planning to enter or expand within Latin America's largest market. We delve into the real-world impact through the case of a European firm whose multi-million dollar product launch was jeopardized overnight. Their meticulously prepared technical dossier was rendered incompatible with the new system, forcing them into a desperate race against time to reformat and resubmit, highlighting the critical need for regulatory agility and expert local representation. 本期干货 1. What are the three most critical technical changes in ANVISA's new PDR platform? 2. Why was no grace period offered for such a major regulatory transition? 3. How does this shift specifically impact the approval timeline for high-risk devices? 4. What are the hidden documentation requirements not listed in the official guidance? 5. How can AI-powered tools accelerate the adaptation of your technical dossier for the new format? 6. Is your current local representative equipped to handle this digital-only transition? 7. What are the key financial risks associated with submission errors on the new platform? 8. How can you leverage this regulatory shift as a competitive advantage? Struggling with market access in Latin America? Pure Global offers end-to-end regulatory consulting, leveraging local expertise and advanced AI to streamline your path to market in over 30 countries, including Brazil, Mexico, and Colombia. Don't let regulatory surprises derail your launch. Contact our experts at info@pureglobal.com or visit https://pureglobal.com/ to secure your market presence.
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    2 min