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  • Pure Global: Brazil's SaMD Surprise—Decoding ANVISA's Hidden Cybersecurity Rules

    Pure Global: Brazil's SaMD Surprise—Decoding ANVISA's Hidden Cybersecurity Rules
    2026/02/13
    Brazil's digital health market is booming, but a recent regulatory update from its agency, ANVISA, has changed the rules of the game for 2026. The new guidance for Software as a Medical Device (SaMD) goes far beyond basic registration, introducing stringent cybersecurity and lifecycle management requirements that are catching many international companies off guard. In this episode, we break down what these changes mean for you. We explore why your existing FDA or CE Mark documentation is no longer sufficient for Brazil and how adapting to these new rules can become your key competitive advantage in Latin America's largest market. **Case Study:** Imagine your company has a cutting-edge AI diagnostic tool, ready to conquer the Brazilian market. You’ve prepared your clinical data, but you suddenly face a rejection because your submission lacks a detailed cybersecurity vulnerability report adapted to Brazil's data privacy laws (LGPD). This unexpected roadblock could delay your launch by over a year, allowing local competitors to capture the market first. Are you prepared for this new reality? **Key questions answered in this episode:** * What specific cybersecurity standards has ANVISA recently mandated for SaMD? * How can you leverage your existing technical file for a successful Brazilian submission? * What are the three most common pitfalls for foreign firms under the new guidelines? * Why is post-market surveillance now as critical as the initial registration? * How does Brazil's new framework signal a larger regulatory trend across LATAM? * What is the crucial first step to take before submitting your digital health product to ANVISA? At Pure Global, we specialize in demystifying these complex regulatory landscapes. Our local experts in Brazil, combined with our AI-driven data tools, provide end-to-end support for your MedTech and IVD products. We transform regulatory hurdles into market opportunities. Ready to accelerate your entry into Brazil? Contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分
  • Brazil's SaMD Surprise: Hacking ANVISA's New Rules | A Pure Global LATAM MedTech Insight

    Brazil's SaMD Surprise: Hacking ANVISA's New Rules | A Pure Global LATAM MedTech Insight
    2026/02/12
    This episode of LATAM MedTech Insights dives into the critical new regulatory guidance from Brazil's ANVISA for Software as a Medical Device (SaMD). As Brazil doubles down on localized requirements, we explore why simply having FDA or CE approval is no longer enough to guarantee market access. We uncover the hidden complexities of ANVISA's risk classification and the growing importance of local data and cybersecurity compliance. We examine a case study of a digital health company whose market launch was delayed by nine months due to unexpected data privacy requirements. This costly setback highlights a critical pain point: underestimating Brazil's unique regulatory interpretation can derail your entire market entry strategy, even with a globally successful product. Key Questions Answered: - Is ANVISA's evolving SaMD framework a hidden barrier or a clear pathway for prepared companies? - How can your SaMD's risk classification unexpectedly change when entering Brazil? - What are the three most common LGPD (Brazil's Data Protection Law) mistakes foreign MedTech firms make? - Why is your choice of a local Brazil Registration Holder (BRH) more critical than ever for software devices? - What post-market surveillance strategies for SaMD will satisfy ANVISA's new focus? - How can you leverage your existing clinical data for the Brazilian market without starting from scratch? Navigating global markets requires more than just a great product; it demands expert regulatory strategy. Pure Global offers end-to-end solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline market access in over 30 countries, including Brazil. Whether you're a startup or a multinational, we are your local representative, ensuring a clear path to registration and post-market compliance. Don't let regulatory hurdles block your growth. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more.
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    2 分
  • Pure Global: Brazil's AI Software Maze - Cracking ANVISA's New Unspoken Code

    Pure Global: Brazil's AI Software Maze - Cracking ANVISA's New Unspoken Code
    2026/02/11
    Brazil's regulatory landscape for AI and software medical devices just got a lot more complex. In this episode, Pure Global dives into ANVISA's latest unspoken rules that demand localized clinical data and stricter adherence to Brazil's data privacy laws, moving beyond simple acceptance of FDA or CE marks. We explore why your existing global dossiers might now be insufficient for the Brazilian market. We break down the new expectations for cybersecurity and the critical importance of validating your technology on local patient populations to ensure a successful product registration. **Case Study:** A U.S. diagnostics firm with a breakthrough AI-powered imaging tool had their Brazilian market entry delayed by six months. Their mistake? They submitted their FDA-cleared validation package without a supplemental study on a Brazilian patient cohort, leading to a cascade of questions from ANVISA that brought their launch to a halt. **Key Takeaways:** * Why is ANVISA now looking beyond FDA and CE approvals for SaMD? * What specific type of local clinical data can make or break your AI device submission in Brazil? * How can Brazil's data privacy law (LGPD) unexpectedly block your medical device approval? * What are the new cybersecurity vulnerabilities ANVISA is actively screening for? * Is it possible to use this regulatory shift to gain an advantage over slower competitors? * What is the number one assumption foreign companies make that leads to rejection? Struggling to keep up with the fast-paced changes in LATAM's regulatory landscape? Pure Global offers end-to-end regulatory consulting, combining local expertise with advanced AI tools to streamline your market access. We act as your local representative, manage technical submissions, and ensure post-market compliance. Don't let regulatory hurdles block your expansion. Contact us for a strategic consultation at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 分
  • Pure Global: Brazil's AI Medical Software Rules - ANVISA's Surprise Roadblock.

    Pure Global: Brazil's AI Medical Software Rules - ANVISA's Surprise Roadblock.
    2026/02/10
    This week, we dive into a sudden and impactful regulatory shift in Brazil. ANVISA, the country's health agency, released a new resolution last week that specifically targets Software as a Medical Device (SaMD), creating significant new hurdles for manufacturers, especially those using AI and machine learning. This update introduces stringent cybersecurity protocols, challenging data localization laws, and a more rigid process for software updates. We explore what these changes mean on the ground through a practical case study. A U.S. diagnostics company, on the verge of launching its FDA-cleared AI cardiac software in Brazil, now finds its entire market entry strategy jeopardized by these new rules. Their reliance on U.S.-based cloud servers and agile development cycles directly conflicts with ANVISA's new mandates, forcing them to consider a costly strategic pivot or abandon the market. Key Takeaways: - What are the three core pillars of ANVISA's new SaMD regulation announced last week? - Why is the new data sovereignty rule a major obstacle for global MedTech companies? - How does the updated change control process impact companies using agile development? - What specific cybersecurity standards are now mandatory for software devices in Brazil? - Can you still leverage your FDA or CE marking for an expedited review under these new rules? - What is the first step you should take if your product is affected by this sudden change? Navigating the complexities of LATAM's regulatory environment is critical for success. At Pure Global, we offer 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. Whether you're dealing with new software regulations in Brazil or planning a multi-market launch, we provide the strategic guidance and in-country representation you need. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    2 分
  • Pure Global: Brazil's AI Software Maze - Cracking ANVISA's New Code

    Pure Global: Brazil's AI Software Maze - Cracking ANVISA's New Code
    2026/02/08
    In this episode, we dissect the breaking news from Brazil where the regulatory agency, ANVISA, has just rolled out a comprehensive and stricter framework for AI-powered Software as a Medical Device (SaMD). This sudden move creates significant new barriers to entry in Latin America's most lucrative MedTech market. We explore the immediate and costly implications for international manufacturers, whose existing global dossiers and market-entry strategies may now be insufficient. We use the real-world example of a company poised to launch its innovative diagnostic software, only to be stopped in its tracks by a new, unexpected demand for local clinical data and cybersecurity compliance, forcing a difficult decision between a costly new trial or abandoning the market. Key Takeaways: - What are the three most critical changes in ANVISA's new SaMD regulation? - Why is Brazil now demanding local clinical data for AI algorithm validation? - How does this new framework impact your existing device classification and submission strategy? - What specific cybersecurity protocols are now mandatory for market access? - Can your existing technical file from the US or EU be leveraged, or must you start from scratch? - What are the hidden costs and timelines associated with this new regulation? - How can you turn this regulatory hurdle into a long-term competitive advantage in the LATAM region? Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI tools to streamline global market access. We act as your local representative in Brazil and over 30 other markets, developing efficient pathways for regulatory approval. Turn regulatory complexity into a strategic advantage. Contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分
  • Pure Global: Mexico's MedTech Shortcut - Unpacking COFEPRIS's New Hurdles

    Pure Global: Mexico's MedTech Shortcut - Unpacking COFEPRIS's New Hurdles
    2026/02/07
    Mexico just opened a new door for MedTech companies. Last week, the country's health authority, COFEPRIS, launched an accelerated approval pathway for devices with existing FDA or CE credentials. This could slash market entry timelines from years to months, but it comes with a catch. This episode dives deep into the opportunities and the hidden compliance traps of this new regulation. We uncover the specific requirements for data privacy and cybersecurity that are unique to Mexico, creating unforeseen challenges for even the most prepared global firms. A US-based company with an innovative, FDA-cleared diagnostic tool sees the news from Mexico and rushes to apply through the new fast-track system. They submit their existing technical file, assuming their robust cybersecurity measures will suffice. Two months later, their application is stalled. The reason: their documentation fails to address Mexico’s specific laws on patient data rights, a nuance they completely overlooked. Now they face significant delays and the costly process of redrafting their submission. Key Questions from this Episode: * Is your medical device eligible for Mexico's new fast-track approval pathway? * What specific documentation from your FDA or CE submission will COFEPRIS accept? * Why is the new 'Cybersecurity and Data Privacy Addendum' the most critical new hurdle? * How do Mexico's data protection laws for medical devices differ from HIPAA and GDPR? * What are the common pitfalls that can lead to rejection under this new system? * How can you leverage your existing approvals to gain a competitive advantage in LATAM? * What are the key responsibilities of a local representative in this new process? Don't let regulatory shifts derail your market entry. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise with advanced AI tools to streamline your access to markets like Mexico. Contact us at info@pureglobal.com or visit https://pureglobal.com/ for a strategic consultation.
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    2 分
  • Pure Global: Brazil's AI MedTech Maze - Cracking ANVISA's New SaMD Rules.

    Pure Global: Brazil's AI MedTech Maze - Cracking ANVISA's New SaMD Rules.
    2026/02/06
    This week, we dive into a major regulatory shift in Latin America's largest MedTech market. Brazil's agency, ANVISA, has just released new, stringent guidance for AI-powered Software as a Medical Device (SaMD). This development creates significant new barriers for foreign manufacturers, moving beyond simple acceptance of international certifications and demanding a highly localized compliance strategy. We explore the three core pillars of this new update: the requirement for clinical data representative of the Brazilian population, specific cybersecurity mandates for data privacy, and the complex new rules for managing self-learning AI algorithms post-market. This episode is essential for any MedTech innovator targeting Brazil. Case Study Spotlight: A French MedTech scale-up, celebrated for its AI diagnostic software with a CE mark, was planning an aggressive Brazilian launch this quarter. Their strategy relied on leveraging their European clinical data. The new ANVISA guidance has abruptly halted their plans, as their data is now deemed insufficient, forcing a costly and time-consuming local validation study they were unprepared for. Key Takeaways: - Does your AI's training data meet ANVISA's new demographic requirements for Brazil? - Is your global cybersecurity plan adequate for Brazil's new, specific reporting protocols? - How will you manage and document post-market changes for your 'learning' algorithm? - Is your existing technical dossier now obsolete under these new SaMD guidelines? - What constitutes a "significant change" for an AI algorithm that requires re-submission to ANVISA? - How can you build a compliant Algorithm Change Protocol from scratch? Navigating the complexities of Brazil's evolving regulatory landscape requires deep local expertise and a proactive strategy. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies. Our team of local experts, combined with advanced AI tools, helps you develop efficient pathways for regulatory approval, compile technical dossiers, and act as your official in-country representative. We turn regulatory hurdles into market opportunities. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your market access.
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    2 分
  • Pure Global: Brazil's ANVISA Shift & The Hidden Dossier Trap

    Pure Global: Brazil's ANVISA Shift & The Hidden Dossier Trap
    2026/02/05
    This week, we dive into a major regulatory shift in Brazil that is catching international MedTech companies off guard. ANVISA's RDC 751/2022 is entering a critical new phase, and the latest clarifications on technical dossier requirements are creating significant hurdles for manufacturers seeking market access. We break down what these changes mean and why your existing FDA or CE mark documentation may no longer be enough. We explore the challenges through a common scenario. Imagine a successful European MedTech company, confident in their CE-marked diagnostic tool, targeting Brazil for their next big expansion. They suddenly face a submission rejection from ANVISA due to "insufficient clinical data" under the new RDC 751 rules. Their launch is now stalled, competitors are gaining ground, and they face the costly, time-consuming task of generating new evidence for a market they don't fully understand. Key Takeaways: * What is the crucial difference between an EU technical file and a Brazilian dossier under RDC 751? * Why is ANVISA's new classification system causing unexpected delays for device makers? * Is your clinical data robust enough for Brazil's heightened scrutiny? * What is the number one documentation mistake companies make when submitting to ANVISA? * How can you turn Brazil's tough regulatory environment into a competitive advantage? * Why might your risk management file be non-compliant, even if it was accepted elsewhere? * What are the unwritten rules for expediting your registration process in Brazil? Navigating the complexities of global markets like Brazil is what we do best. Pure Global offers end-to-end regulatory consulting, combining local expertise with advanced AI tools to streamline market access. Don't let regulatory hurdles derail your expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can secure your entry into Latin America.
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    2 分