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  • Navigating Brazil's ANVISA RDC 751 & RDC 830: A Pure Global Guide to LATAM MedTech & IVD Market Access Success

    Navigating Brazil's ANVISA RDC 751 & RDC 830: A Pure Global Guide to LATAM MedTech & IVD Market Access Success
    2025/10/17
    This episode of LATAM MedTech Insights dives deep into the most significant regulatory shift in the region's largest market: Brazil. We explore ANVISA's new regulations, RDC 751/2022 for medical devices and RDC 830/2023 for IVDs, which align Brazil's framework more closely with international standards like the EU MDR. This is a critical update for any MedTech company looking to enter or expand its footprint in Latin America. We unpack what this harmonization means in practical terms. Consider this: a medical device company with CE marking for its product previously faced a complex, 18-month process to reformat its entire technical dossier for Brazil. Today, that same dossier can be leveraged to gain market access in a fraction of the time and cost. This episode explains how you can capitalize on this change and avoid common pitfalls during the transition. Key Takeaways: * How does Brazil's new RDC 751/2022 fundamentally change the market entry strategy for your medical device? * What is the critical June 1, 2024 deadline for IVD manufacturers under RDC 830/2023 and what must be done? * Can your existing EU or FDA technical documentation be used for a submission in Brazil now? * How does Brazil's regulatory shift compare to changes happening in Mexico and Colombia? * What are the key differences between the old 'cadastro' system and the new 'notificação' pathway? * Why is having an expert local representative in Brazil more crucial than ever under these new rules? * What are the most common mistakes companies make when transitioning their legacy products to the new regulations? Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies. We combine local expertise with advanced AI and data tools to streamline your global market access, from initial strategy to post-market surveillance. To navigate the complexities of the LATAM market, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分
  • Unlocking LATAM MedTech: How Pure Global Leverages Market Intelligence on Colombia and Brazil for Strategic Entry

    Unlocking LATAM MedTech: How Pure Global Leverages Market Intelligence on Colombia and Brazil for Strategic Entry
    2025/10/16
    In this episode of LATAM MedTech Insights, we explore why a one-size-fits-all approach to entering the Latin American medical technology market is a recipe for failure. The region is not a monolith but a collection of unique countries, each with its own distinct regulatory, economic, and healthcare systems. Success depends on moving beyond surface-level data and leveraging deep market intelligence. We dissect how granular market briefs provide the critical insights needed to build a winning go-to-market strategy. We contrast the opportunities in a market like Colombia, which heavily relies on imports, with the complex regulatory hurdles of a giant like Brazil. This episode will show you how the right data can illuminate your path, save you from costly mistakes, and give you a decisive competitive advantage. A Tale of Two Markets: Imagine targeting Colombia, where an 80% import dependency for medical devices signals a ready-made demand for your product. Now, picture Brazil, where your market entry is halted before it begins because you were unaware of the mandatory pre-submission GMP inspection by ANVISA. This single regulatory detail could delay your launch by over a year and add tens of thousands to your budget. Which path would you rather take? Key Takeaways: * Why is treating LATAM as a single market the most common strategic error? * What does Colombia's 80% import dependency really mean for your sales strategy? * How can Brazil's ANVISA pre-registration requirements completely alter your budget and timeline? * Beyond market size, what are the most critical data points a market brief must contain? * How does deep market intelligence inform your choice between direct entry and a distributor model? * What hidden regulatory hurdles could derail your launch in promising markets? * How can you leverage existing international approvals to potentially fast-track your LATAM entry? * What economic indicators should you monitor that directly impact medical device reimbursement? At Pure Global, we transform this critical data into actionable strategy. We offer end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline your global market access. Stop guessing and start strategizing. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can help you succeed in Latin America and beyond.
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    2 分
  • Pure Global's Deep Dive into Brazil: Mastering ANVISA MedTech Regulations with an Integrated Registration & PMS Strategy

    Pure Global's Deep Dive into Brazil: Mastering ANVISA MedTech Regulations with an Integrated Registration & PMS Strategy
    2025/10/15
    Brazil's MedTech market offers immense opportunity, but its regulatory body, ANVISA, demands flawless execution. A fragmented approach, where different teams handle registration and post-market compliance, often leads to costly delays and strategic dead ends. This episode explores why an integrated strategy is non-negotiable for success. We break down the four pillars of Brazilian MedTech regulation: correct device classification, meticulous technical documentation in Portuguese, the critical choice of a Brazil Registration Holder (BRH), and robust post-market surveillance. Learn how these elements are interconnected and why managing them under one expert team provides a significant competitive advantage in this complex market. **A cautionary tale:** Imagine spending over a year and thousands of dollars to prepare your device registration, only to discover that the distributor you appointed as your local representative (BRH) has decided to partner with a competitor. Because they legally own your registration license, you have completely lost market access and must start the entire process from scratch, giving your competition a two-year head start. **In this episode, you will learn:** * Why is Brazil's four-class risk system more nuanced than it appears? * What are the most common documentation mistakes that lead to ANVISA rejections? * How can the choice of your Brazil Registration Holder (BRH) make or break your entire LATAM strategy? * Are you truly in control of your device registration if your distributor is your BRH? * What specific post-market surveillance activities does ANVISA require beyond simple adverse event reporting? * Why is having a single, integrated team for registration and post-market support a competitive advantage in Brazil? * What is BGMP certification and why is it non-negotiable for higher-risk devices? At Pure Global, we offer end-to-end regulatory solutions for MedTech and IVD companies. Our integrated approach combines local Brazilian expertise with advanced AI tools to streamline market access, from initial strategy to post-market surveillance. Contact us to learn how our unified team can de-risk and accelerate your entry into the Brazilian market. Email us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分
  • Fast-Track Your LATAM Entry: Pure Global’s Guide to Colombia’s Automatic Registration for Low-Risk MedTech and Navigating High-Risk Approvals.

    Fast-Track Your LATAM Entry: Pure Global’s Guide to Colombia’s Automatic Registration for Low-Risk MedTech and Navigating High-Risk Approvals.
    2025/10/14
    In this episode of LATAM MedTech Insights, we dive deep into the unique regulatory landscape of Colombia, a pivotal market for any device manufacturer looking to enter Latin America. We uncover how INVIMA's dual-track system offers a strategic gateway for MedTech companies that know how to leverage it. We explore the powerful "automatic registration" pathway for low-risk devices that can get your product to market and generating revenue faster than you think. We also break down the complexities and extended timelines associated with the rigorous pre-approval process for high-risk technologies, and how to plan for them effectively. A Case for Strategy: Imagine trying to launch your entire device portfolio, from simple monitors to complex implants, into a new continent at once. The pain point is the immense upfront cost and the years of waiting for approvals before seeing a single dollar in return. One company flipped this challenge on its head. They launched their Class I device in Colombia in just a few months, using the immediate cash flow to fund the lengthy, data-intensive registration for their groundbreaking Class III product. This is how a regulatory landscape becomes a competitive advantage. This episode's key takeaways: 1. What is Colombia's "automatic registration" and which specific devices qualify? 2. How can a fast-track for low-risk products actually fund your entire LATAM expansion? 3. What are the most common documentation pitfalls that lead to rejection in an "automatic" submission? 4. How do you prepare a technical dossier for a high-risk Class III device that satisfies INVIMA's stringent review? 5. Why is a staggered, portfolio-based market entry strategy essential for success in Colombia? 6. How does your Colombian approval act as a potential stepping stone for other LATAM markets? 7. What are the critical roles and responsibilities of a local Legal Representative in the INVIMA process? At Pure Global, we specialize in transforming complex regulatory landscapes into clear, actionable market access strategies. Our teams of local experts, powered by advanced AI and data tools, offer end-to-end solutions for MedTech and IVD companies. Whether you are navigating Colombia's INVIMA for the first time or expanding across the continent, we streamline your path to market. Ready to build your LATAM strategy? Contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分
  • Cracking Argentina's ANMAT: A MedTech Manufacturer's Guide to Local Registration Success with Pure Global

    Cracking Argentina's ANMAT: A MedTech Manufacturer's Guide to Local Registration Success with Pure Global
    2025/10/13
    In this episode of LATAM MedTech Insights, we demystify the complex process of medical device registration in Argentina. We provide a detailed guide on navigating the requirements of the national regulatory authority, ANMAT, from appointing a local registration holder to preparing a compliant technical dossier in Spanish. We break down the critical steps and common pitfalls that can lead to costly delays and rejections. Learn why your choice of a local partner can make or break your market access strategy and how your existing international approvals, like CE or FDA, fit into the Argentinian framework. We share a real-world case where a simple oversight in device grouping strategy tripled a company's registration costs and delayed market entry by a full year, highlighting the financial and strategic importance of local know-how. Key questions answered in this episode: - Why is selecting the right Argentina Registration Holder (ARH) your most critical first step? - What are the specific Spanish language requirements for your technical file that most companies miss? - How can a proper device family strategy cut your ANMAT submission costs and timeline? - What is the one common document error that causes the longest delays with ANMAT's review clock? - Are your existing CE or FDA approvals enough to guarantee a smooth registration in Argentina? - What are the realistic timelines you should expect for ANMAT approval for different device classes? - How can you avoid having your registration "held hostage" by a local commercial partner? At Pure Global, we provide end-to-end regulatory solutions for MedTech companies seeking to enter or expand in Latin America. Our local experts in Argentina, combined with our advanced AI tools, streamline the ANMAT registration process, from strategy and dossier preparation to post-market compliance. Let us be your dedicated partner in unlocking this key market. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    2 分
  • Pure Global's Guide to Peru: Navigating DIGEMID and the Essential Role of a Local Registration Holder for MedTech Success

    Pure Global's Guide to Peru: Navigating DIGEMID and the Essential Role of a Local Registration Holder for MedTech Success
    2025/10/12
    Peru's MedTech market offers immense growth opportunities, but entry is strictly controlled by its regulatory authority, DIGEMID. A critical step for any foreign manufacturer is appointing a local representative, known as a Peru Registration Holder. This isn't just a formality—it's a foundational strategic decision that dictates your control over your own products in the country. In this episode, we explore why the common shortcut of letting a distributor hold your product registration can lead to significant business risks, including a complete loss of market access. We'll walk through the strategic advantages of appointing an independent, professional representative to ensure you maintain full control over your commercial strategy and long-term success in Peru. Here is a situation we explore: Imagine your medical device has been selling in Peru for two years. Your relationship with your distributor, who also holds your DIGEMID registration, has broken down. You decide to switch partners, only to discover the distributor refuses to transfer the registration. They legally own your access to the market. You are now faced with a devastating choice: stay with an underperforming partner or pull your product and start the costly, year-long registration process all over again. This is a real and preventable crisis. Key Takeaways: 1. What is the precise function of a "Peru Registration Holder" for DIGEMID? 2. Why is it a significant risk to let your distributor be your registration holder? 3. What are the legal implications of who owns your product registration in Peru? 4. How does an independent local representative provide crucial commercial flexibility? 5. What happens to your market access if your relationship with your distributor-holder ends? 6. What are the key steps in the DIGEMID registration process that a local representative handles? 7. How does having a dedicated representative help in navigating post-market surveillance in Peru? At Pure Global, we specialize in demystifying complex regulatory landscapes like Peru's. We provide independent, expert local representation, ensuring you retain full control over your assets while we handle the complexities of DIGEMID. Secure your market access and build a flexible, scalable LATAM strategy. Contact us to learn more at info@pureglobal.com or visit our website at https://pureglobal.com/.
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    2 分
  • Pure Global's LATAM MedTech Insights: Unlocking a Decade of Market Access with Colombia's 10-Year INVIMA Registration.

    Pure Global's LATAM MedTech Insights: Unlocking a Decade of Market Access with Colombia's 10-Year INVIMA Registration.
    2025/10/11
    This episode of LATAM MedTech Insights dives into one of the most stable and attractive regulatory environments in Latin America: Colombia. We explore how INVIMA, the national regulatory authority, offers a clear and predictable pathway for medical device manufacturers, standing in contrast to the complexities found elsewhere in the region. We specifically focus on the significant strategic advantage of Colombia's ten-year registration validity for most medical devices. This episode unpacks how this long-term approval cycle can reduce administrative burdens, lower costs, and enable companies to focus on sustainable market growth instead of constant regulatory upkeep. A real-world pain point we address is the risk of losing market access. Imagine a company thriving in Colombia, only to realize their local partner missed the critical 90-day renewal submission deadline with INVIMA. This oversight forces their product off the market, jeopardizing distributor contracts and revenue streams, all of which could have been avoided with proactive regulatory management. In this episode, you will learn the answers to key questions: 1. Why is a 10-year registration validity a game-changer for your MedTech commercial strategy in LATAM? 2. What is the single most important deadline you cannot miss when renewing your INVIMA registration? 3. How does a reliable local representative in Colombia provide value beyond just submitting paperwork? 4. What are the common pitfalls that cause companies to lose their market access in Colombia, even with a long validity period? 5. How can you leverage your stable Colombian registration to plan for expansion into other Andean markets? 6. What key documents should you be preparing years in advance of your 10-year renewal? 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 Colombia and over 30 other markets, ensuring your registrations are managed proactively and your market presence is secure. To learn more, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分
  • Navigating Brazil's 2025 UDI Mandate: A Pure Global Guide to ANVISA's SIUD for MedTech Success in LATAM

    Navigating Brazil's 2025 UDI Mandate: A Pure Global Guide to ANVISA's SIUD for MedTech Success in LATAM
    2025/10/10
    Brazil, Latin America's largest MedTech market, is implementing a mandatory Unique Device Identification (UDI) system, with a critical deadline for high-risk devices looming in mid-2025. This change, mandated by ANVISA's RDC 591/2021, requires immediate action from manufacturers to ensure their products remain on the market. This episode of LATAM MedTech Insights breaks down the essential steps for preparing for Brazil's UDI rollout. We explore the unique challenge where device labeling is required before the official government database (SIUD) is fully active, creating significant operational hurdles. We'll provide a clear roadmap for what your company needs to do right now to avoid costly disruptions to your Brazilian operations. **Case Study Highlight:** Imagine your company manufactures a Class IV cardiovascular stent. You have all the clinical approvals, but your product is suddenly blocked from entering Brazil on July 11, 2025. The reason is a non-compliant label. Your team waited for final guidance on the UDI database, but the fixed labeling deadline passed, halting your sales and forcing an expensive, rushed relabeling project. This scenario is avoidable, and this episode explains how. **What You'll Learn (本期干货):** * What is the crucial compliance date in 2025 that affects all Class IV medical devices in Brazil? * Why do you need to change your product labels now, even if the SIUD database isn't live? * How do ANVISA's UDI data requirements differ from those of the US FDA or European MDR? * What are the first three steps every manufacturer should take to begin their UDI implementation project? * What is the essential role of a Brazil Registration Holder (BRH) in this new process? * How can you manage the artwork and logistical challenges of a full labeling redesign? * What are the most common pitfalls companies face when preparing for a new UDI system? At Pure Global, we offer end-to-end regulatory consulting to help MedTech and IVD companies navigate complex market access challenges like Brazil's UDI implementation. We combine local expertise with advanced AI tools to streamline your path to compliance. For support with regulatory strategy, technical dossier submission, or local representation in Brazil, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分