Episodes

  • Cracking COFEPRIS: The Critical Stages After Your Mexican Device Submission

    Cracking COFEPRIS: The Critical Stages After Your Mexican Device Submission
    Jul 5 2025
    This episode demystifies the complex journey a medical device registration takes in Mexico *after* the initial dossier is submitted to COFEPRIS. We explore the critical post-submission phases, from the initial review and the dreaded 'prevención' (request for information) to the final certificate issuance and vital post-market responsibilities. Learn about the different review pathways, including the Standard, Equivalency, and Third-Party Reviewer (TPR) routes, and understand the crucial steps needed to maintain your registration long-term. Key Questions: • What really happens after you click "submit" on your COFEPRIS application? • How can a 'prevención' (request for information) impact your registration timeline? • Is a manufacturing facility inspection always required? • What are the differences between the Standard, Equivalency, and Third-Party Review pathways? • Why is checking your final registration certificate for errors so critical? • How long is a COFEPRIS registration valid and what does the renewal process involve? • What changes to your device or company require a formal modification with COFEPRIS? • Can using a Third-Party Reviewer (TPR) actually speed up your approval? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 mins
  • Beyond the Hospital: The Rise of Long-Term Care Devices

    Beyond the Hospital: The Rise of Long-Term Care Devices
    Jul 4 2025
    This episode delves into the rapidly growing Long-Term Care (LTC) market, explaining what it is, the demographic shifts driving its expansion, and its critical link to the medical device industry. We explore the evolution from basic equipment to advanced technologies like IoT, remote patient monitoring, and AI, highlighting the future trends and opportunities for MedTech manufacturers. • What is Long-Term Care (LTC) and why is it becoming a critical healthcare sector? • What global demographic trends are causing the LTC market to skyrocket? • How large is the market projected to be by 2030? • How is the role of medical devices in LTC evolving beyond basic mobility aids? • What are the key technology trends, like remote monitoring and telehealth, shaping the future of care? • How will Artificial Intelligence transform device capabilities and patient outcomes? • Why is the "aging in place" phenomenon a major opportunity for MedTech innovation? • What new types of devices are in high demand for home healthcare settings? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 mins
  • Beyond the Great Wall: Unlocking China's Medical Device Market in 2025

    Beyond the Great Wall: Unlocking China's Medical Device Market in 2025
    Jul 3 2025
    China's medical device market is poised for significant growth leading into 2025, driven by an aging population and government initiatives like "Healthy China 2030." However, foreign manufacturers face new challenges, including fierce local competition, pro-domestic procurement policies, and the complexities of the NMPA regulatory system. This episode breaks down the market outlook for 2025, exploring the key drivers, the critical challenges, and the localized strategies required to succeed in this evolving landscape. Key Questions: • What are the latest growth forecasts for China's MedTech market in 2025 and beyond? • How is the "Healthy China 2030" policy impacting opportunities for foreign companies? • Why is a "Made in China" strategy becoming essential for market access? • What are the biggest regulatory hurdles presented by the NMPA? • How is the rise of local competitors and Volume-Based Procurement (VBP) affecting pricing and strategy? • Which device categories, such as AI and robotics, show the most promise for foreign brands? • What are the most effective market entry models for navigating the 2025 landscape? • Is it still possible for international medical device companies to succeed in China? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 mins
  • MedTech Compliance 101: Your Guide to Entering Global Markets

    MedTech Compliance 101: Your Guide to Entering Global Markets
    Jun 30 2025
    This episode provides a foundational guide for MedTech companies looking to export their devices. We break down the essential first steps of global regulatory compliance, from understanding device classification and risk levels to implementing a robust Quality Management System (QMS) based on ISO 13485. We’ll also touch on the specific requirements of major markets like the United States (FDA) and the European Union (EU MDR). Key Questions: • What is the absolute first step before exporting a medical device? • How does a device's risk level impact its regulatory journey? • What is a Quality Management System (QMS) and why is ISO 13485 the gold standard? • What are the key differences between the US FDA and EU MDR requirements? • How did the EU MDR, effective May 2021, change the game for manufacturers? • Why is risk management (ISO 14971) a continuous process? • How can a company prepare for audits in multiple countries? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 mins
  • Unlocking Market Access: A Guide to Clinical Evaluation & Investigations

    Unlocking Market Access: A Guide to Clinical Evaluation & Investigations
    Jun 29 2025
    This episode demystifies the essential processes of Clinical Evaluation and Clinical Investigation under the EU's Medical Device Regulation (MDR). We break down the entire lifecycle, from creating a Clinical Evaluation Plan (CEP) and gathering sufficient clinical data to compiling the Clinical Evaluation Report (CER) and executing Post-Market Clinical Follow-up (PMCF) to ensure long-term safety and performance. • What is a Clinical Evaluation, and why is it a continuous process? • When can you use existing literature versus needing a full clinical investigation? • What are the essential components of a Clinical Evaluation Plan (CEP)? • How has the EU MDR changed the requirements for demonstrating device equivalence? • What is the role of ISO 14155 in conducting clinical investigations? • How does the Clinical Evaluation Report (CER) prove a device's benefit-risk profile? • What is Post-Market Clinical Follow-up (PMCF), and how does it connect to vigilance? • How do you navigate the data requirements for legacy and high-risk devices? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 mins
  • From Dossier to Dominance: Mastering Pre-Market Submissions

    From Dossier to Dominance: Mastering Pre-Market Submissions
    Jun 28 2025
    This episode breaks down the essential pre-market requirements for medical devices, from compiling robust technical documentation to navigating the distinct submission pathways in major global markets. We explore the critical components of a design dossier, including the 510(k), PMA, and CE marking processes, and offer strategies for efficient device grouping and dossier management. • What are the foundational elements of technical documentation for a medical device? • How do EU MDR requirements for CE marking differ from the FDA's 510(k) and PMA pathways? • What is the importance of the General Safety and Performance Requirements (GSPRs)? • How can device grouping principles streamline your regulatory submissions? • What makes a clinical evaluation report compelling to regulators? • Why is a comprehensive risk management file (ISO 14971) non-negotiable? • How can you create a master dossier to simplify global submissions? • What are the latest transition deadlines under the EU MDR that you must be aware of? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 mins