Episodes

  • 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.
    Show More Show Less
    2 mins
  • Pure Global: Mexico's COFEPRIS Shortcut - A New MedTech Backdoor for US/EU Devices?

    Pure Global: Mexico's COFEPRIS Shortcut - A New MedTech Backdoor for US/EU Devices?
    Jan 12 2026
    This week, we dive into the groundbreaking news from Mexico's regulatory agency, COFEPRIS. A new fast-track "equivalency agreement" has been announced, set to revolutionize market access for medical device companies with existing US FDA or European CE Mark approval. This episode unpacks the details of this new pathway, exploring the immense opportunities it creates for international MedTech firms. We break down what this regulatory shift means for your business strategy in Latin America. This isn't just a minor update; it's a strategic move by Mexico to become the primary landing spot for MedTech innovation and investment in the region. We analyze the immediate benefits and the potential long-term competitive advantages for companies that act quickly. ## What You'll Learn: * What is the new COFEPRIS "equivalency agreement" and how does it actually work? * Which specific device classes are eligible for this new fast-track process? * How does this change Mexico's position against other LATAM markets like Brazil? * What are the critical documentation requirements needed to leverage your existing FDA or CE approval? * Are there any hidden pitfalls or new compliance details to watch out for in this streamlined process? * How can this new rule drastically reduce your company’s time-to-market and registration costs? * What does this mean for local Mexican manufacturers and the competitive landscape? * Is this the first step toward broader regulatory harmonization across Latin America? Navigating these complex changes requires local expertise and a global perspective. Pure Global offers end-to-end regulatory consulting for MedTech companies, combining local experts with AI tools to streamline global market access. We act as your local representative to ensure you can capitalize on new regulations efficiently. To learn how we can accelerate your entry into the Mexican market, contact us at info@pureglobal.com or visit https://pureglobal.com/.
    Show More Show Less
    2 mins
  • Brazil's AI MedTech Gold Rush: ANVISA's Hidden Rules | Pure Global Insights

    Brazil's AI MedTech Gold Rush: ANVISA's Hidden Rules | Pure Global Insights
    Jan 11 2026
    This week, we dissect the groundbreaking news from Brazil's ANVISA: a new fast-track approval pathway for AI-powered medical devices. This move promises to slash approval times and revolutionize the digital health landscape, but the opportunities are wrapped in complex new challenges. We go beyond the headlines to explore the intricate new requirements for clinical data, cybersecurity, and local data privacy laws that could derail even the most prepared global companies. Discover why this "shortcut" might be a longer road than expected without the right local strategy. A specific case: A successful European AI diagnostic tool, fully approved in the EU, gets rejected by ANVISA's new fast-track system. The fatal flaw? Its clinical data wasn't validated on Brazil's diverse population demographics, making it unusable in the local context. This is the exact pitfall we help you avoid. Key Takeaways This Episode: - What are the three specific types of AI software ANVISA is prioritizing? - Why might the 90-day approval promise be misleading for foreign manufacturers? - How does Brazil's LGPD data privacy law create new compliance traps in the fast-track application? - What's the number one mistake companies make when submitting clinical data for the Brazilian market? - How can you prove your algorithm is free from demographic bias for ANVISA's review? - Which specific cybersecurity protocols are now mandatory for the fast-track application? - Is it now easier or harder for startups to compete with established players under this new system? Navigating the complexities of market access in Latin America requires localized expertise and a strategic partner. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, using local experts and advanced AI to streamline your path to market. To tackle challenges like ANVISA's new regulations and accelerate your entry into Brazil, contact us at info@pureglobal.com or visit https://pureglobal.com/.
    Show More Show Less
    2 mins
  • Brazil's AI MedTech Shake-Up: Pure Global on Cracking ANVISA's New Cybersecurity Code

    Brazil's AI MedTech Shake-Up: Pure Global on Cracking ANVISA's New Cybersecurity Code
    Jan 9 2026
    This week, we dive into a major regulatory shift in Brazil that's sending shockwaves through the digital health sector. ANVISA, the national health surveillance agency, has just released RDC 899, a groundbreaking resolution that imposes stringent new cybersecurity and data privacy rules for all Software as a Medical Device (SaMD). This update creates immediate challenges for MedTech companies, especially those leveraging AI and machine learning. The resolution requires deep integration with Brazil's data protection laws (LGPD) and demands unprecedented transparency into algorithm validation. We break down the core components of RDC 899 and what they mean for your products, whether you're seeking new registration or preparing for a renewal. A European AI diagnostics company, with a device already successful in the Brazilian market, is now facing a critical challenge. Their upcoming registration renewal requires them to retroactively create an entire cybersecurity risk portfolio and provide detailed validation data for their proprietary algorithms. This unexpected task threatens to delay their renewal, potentially costing them millions in revenue and market position. How can you avoid this costly pitfall? Key Takeaways This Episode: * What are the three mandatory documents now required under ANVISA's RDC 899? * How does Brazil's data protection law, the LGPD, now directly impact your SaMD's software architecture? * For AI-driven devices, what specific information about your training datasets must now be submitted to ANVISA? * What is the immediate risk for devices that are already registered and approaching their renewal date? * How can you turn this new regulatory hurdle into a competitive advantage in the Brazilian market? * What are the unwritten expectations from ANVISA when reviewing these new cybersecurity files? 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 act as your local representative in over 30 markets, including Brazil, ensuring you can navigate complex changes like RDC 899 without delaying your growth. Don't let regulatory surprises derail your launch. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your market presence.
    Show More Show Less
    2 mins
  • Pure Global: Brazil's ANVISA 2025 Regs - Navigating Hidden Compliance Traps.

    Pure Global: Brazil's ANVISA 2025 Regs - Navigating Hidden Compliance Traps.
    Jan 8 2026
    This week on LATAM MedTech Insights, we dissect the latest 2025 medical device registration guidance from Brazil's ANVISA. While the new framework aims to streamline market access, it has introduced a host of undocumented challenges that are causing significant delays for international manufacturers. We explore the gap between the official regulations and the practical hurdles companies are facing right now. From the specific demands of the new digital submission portal to the increased technical scrutiny placed on local representatives, this episode provides a crucial look at the unwritten rules of Brazilian MedTech regulation. We uncover the real reasons behind recent submission rejections and offer insights into how companies can avoid common pitfalls and accelerate their path to market in Latin America's largest economy. **Case Study:** A US-based orthopedic device company prepared their ANVISA submission based on their recent FDA 510(k) clearance. They were confident in their data, but their application was stalled for months. The issue? Their designated Brazil Registration Holder (BRH) was unable to adequately respond to ANVISA's technical questions regarding the specific biomechanical properties of the device, a level of scrutiny the company had never anticipated, forcing them to find a new, technically proficient local partner and restart the clock on their review. **Key Takeaways This Episode:** * Is your technical dossier truly prepared for ANVISA's new, unwritten formatting rules for 2025? * How can you adapt your existing FDA or CE Mark data to satisfy Brazil-specific risk analysis requirements? * Is your chosen Brazil Registration Holder (BRH) merely an administrative contact, or a true technical expert? * What are the most common, unexpected reasons for rejection under the new digital submission system? * How do you build a realistic timeline that accounts for unpredictable INMETRO certification delays? * Are you prepared for ANVISA's increasingly deep technical questions during the review phase? Navigating these regulatory mazes is our expertise. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining deep local expertise in markets like Brazil with advanced AI tools to streamline your global market access. Don't let regulatory hurdles derail your launch. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can help.
    Show More Show Less
    2 mins
  • Pure Global: Decoding Brazil's Shock ANVISA Shift on MedTech Clinical Data.

    Pure Global: Decoding Brazil's Shock ANVISA Shift on MedTech Clinical Data.
    Jan 7 2026
    This week, we dissect the surprise technical note from Brazil's ANVISA that just reshaped the rules for market entry. This clarification to RDC 751 demands more stringent, localized clinical evidence for high-risk devices, creating a significant new hurdle for international MedTech manufacturers looking to enter Latin America's largest market. We explore the immediate impact on companies that have long relied on their FDA or CE Marking data for Brazilian submissions. This isn't just a new piece of paperwork; it represents a fundamental shift in regulatory philosophy that could delay product launches, inflate budgets, and force a complete strategic rethink for companies targeting Brazil. **Case In Point:** A US-based orthopedic device manufacturer was weeks away from submitting their ANVISA application for a novel spinal implant. Their entire submission was built on extensive US and EU clinical trials. The new guidance has put their entire launch on hold, forcing them to confront the unexpected need for a local bridging study, potentially setting their timeline back by over a year and adding millions to their budget. **In this episode, you will learn:** - What specific clinical evidence is ANVISA now demanding under the new RDC 751 clarification? - Why is your existing international clinical data suddenly not enough for the Brazilian market? - Which high-risk device categories are most affected by this regulatory shift? - How can you determine if your current technical dossier meets these new, stricter requirements? - What are the strategic options for generating Brazil-specific clinical evidence without breaking the bank? - Is this new stance from ANVISA a leading indicator for similar changes in other LATAM countries? - How can proactive regulatory planning turn this potential barrier into a competitive advantage? At Pure Global, we specialize in transforming these complex regulatory challenges into clear market access strategies. With our end-to-end consulting, local expertise in over 30 markets, and advanced AI data tools, we streamline the path for MedTech and IVD companies entering markets like Brazil. We act as your local representative, manage technical dossiers, and provide the continuous regulatory monitoring needed to stay ahead of changes like this one. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your market presence.
    Show More Show Less
    2 mins
  • Pure Global | Brazil's MedTech Shift: Cracking ANVISA's New Digital Certificate Code

    Pure Global | Brazil's MedTech Shift: Cracking ANVISA's New Digital Certificate Code
    Jan 6 2026
    Brazil's health agency, ANVISA, has just launched a new digital portal, ending weeks-long delays for essential medical device certificates. This major shift from paper to a fully online system promises to accelerate market access, enhance transparency, and slash the administrative burden that has long frustrated manufacturers trying to enter Latin America's largest market. This episode breaks down what this digital transformation truly means for the industry. Consider a company whose multi-million dollar product launch was stalled for two months, not by regulatory hurdles, but by the wait for a single, physical GMP certificate. We explore how the new instant, online process eliminates this critical bottleneck, changing the game for logistics, sales, and getting vital medical technology to patients faster. **Key Takeaways:** * Which specific certificates are now available through ANVISA's new digital portal? * How does this change impact the timeline for post-approval market launch in Brazil? * What are the immediate operational steps your company must take to use this new system? * Does the digital certificate hold the same legal weight for customs and distributors? * How can this move signal broader digital transformation trends within other LATAM agencies? * What are the potential cybersecurity concerns with a fully digital certification process? * Are there new fees associated with these online requests compared to the old system? At Pure Global, we offer end-to-end regulatory solutions to navigate these changes seamlessly. Our local experts in Brazil and advanced AI tools streamline market access, from registration strategy to post-market surveillance. Let us help you turn regulatory updates into a competitive advantage. Contact us at info@pureglobal.com or visit https://pureglobal.com/.
    Show More Show Less
    2 mins
  • Pure Global: Mexico's DigiReg Shift - Navigating COFEPRIS's Simplification Paradox

    Pure Global: Mexico's DigiReg Shift - Navigating COFEPRIS's Simplification Paradox
    Jan 3 2026
    In this episode of LATAM MedTech Insights, we dissect the chaotic rollout of COFEPRIS's new mandatory digital platform, 'DigiReg'. Launched in the last week of December 2025, this platform was meant to be the final step in simplifying medical device registration in Mexico. Instead, it has created a maze of technical glitches and undocumented requirements. We explore how this "simplification paradox" is catching foreign manufacturers off guard. For instance, a leading European diagnostics firm found their application for a new IVD product stalled. They were perfectly compliant with the rules published just months ago, but the DigiReg platform is now rejecting their submission due to cryptic data validation errors, with no clear guidance from COFEPRIS on how to resolve them, putting their entire market entry strategy at risk. Key Takeaways for this episode: - What are the top three undocumented requirements in the new DigiReg platform causing immediate rejections? - How has the supposedly 'simplified' registration pathway become more complex for foreign manufacturers? - Why is your existing technical dossier suddenly non-compliant with the new digital standards? - What are the critical advantages of having a local representative to navigate DigiReg's interface and communication hurdles? - How can you adapt your submission strategy to avoid the common pitfalls of this new system? - Are there any workarounds for the platform’s current technical glitches to keep your registration on track? Navigating sudden regulatory shifts in fast-moving markets like Mexico is our expertise. Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies. With our local experts in Mexico and advanced AI tools, we streamline the entire submission process, ensuring your technical dossier meets the latest digital requirements of platforms like DigiReg. Don't let regulatory surprises delay your market access. Contact Pure Global at info@pureglobal.com or visit us at https://pureglobal.com/.
    Show More Show Less
    2 mins