Épisodes

  • FDA vs. EU: Decoding Medical Device Risk and Classification Pathways

    FDA vs. EU: Decoding Medical Device Risk and Classification Pathways
    Jun 26 2025
    This episode demystifies the critical process of medical device classification in the US and EU. Learn the principles behind risk-based classification and how it directly impacts your path to market, from documentation to regulatory scrutiny. Key Questions: • What are the three medical device risk classes in the United States? • How does the EU's four-class system (I, IIa, IIb, III) differ from the FDA's? • Why is a device's classification the single most important factor for its regulatory strategy? • What is a 510(k) and when is it required? • What is a Premarket Approval (PMA) application? • How does risk level determine the need for a Notified Body in Europe? • What is a CE Mark and how is it related to device class? • What are the consequences of misclassifying your medical device? 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 min
  • The Gatekeepers of Global MedTech: Decoding the FDA, EMA, and NMPA

    The Gatekeepers of Global MedTech: Decoding the FDA, EMA, and NMPA
    Jun 25 2025
    This episode demystifies the world's leading medical device regulatory bodies. We break down the distinct structures, approval pathways, and critical requirements of the FDA (USA), the EMA (EU), and the NMPA (China), providing the essential knowledge needed to begin crafting a global market strategy. Key Questions: • What are the fundamental differences between the FDA's centralized system and the EMA's Notified Body approach? • How does a device's risk classification impact its path to market in the US, EU, and China? • What is a 510(k) clearance, and when is a more stringent Premarket Approval (PMA) required by the FDA? • Why is the CE Mark essential for European market access? • What unique challenges, like local clinical trial requirements, does China's NMPA present? • What is the importance of the FDA's Quality Management System Regulation update, effective February 2, 2026? • What are the roles of other key agencies like Health Canada and Japan's PMDA? 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 min
  • From Stressed to Prepared: A Guide to Acing MedTech Audits

    From Stressed to Prepared: A Guide to Acing MedTech Audits
    Jun 24 2025
    This episode provides a comprehensive, step-by-step guide to achieving and maintaining medical device audit readiness. The host outlines how to move beyond last-minute preparation by embedding a culture of quality and compliance into your daily operations. Key topics include implementing a robust QMS, conducting proactive internal audits, leveraging technology for documentation, and managing the audit process from preparation to post-audit actions. Key Questions: • How can you transform audit preparation from a last-minute scramble into a daily practice? • What are the essential components of a robust Quality Management System that satisfies auditors? • Why are regular internal audits your most powerful tool for proactive compliance? • How do you effectively train your team to be confident and competent during an inspection? • What specific documentation must be perfectly organized and accessible before an auditor arrives? • How can technology streamline your audit readiness and ensure traceability? • What are the key strategies for managing the audit day itself to ensure a smooth process? • How should you respond to audit findings to demonstrate continuous improvement? 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 min
  • South Asia's MedTech Surge: A Guide to Market Trends & Opportunities

    South Asia's MedTech Surge: A Guide to Market Trends & Opportunities
    Jun 23 2025
    This episode provides a comprehensive overview of the South Asian medical device market, highlighting key growth drivers, market size projections, and regulatory trends. We explore the unique dynamics of countries like India, Pakistan, and Bangladesh, comparing the region's trajectory with that of Southeast Asia and identifying the most promising sectors for manufacturers and investors. • How large will the South Asian medical device market be by 2025? • What key factors are fueling the rapid expansion of India's MedTech sector? • How do customer preferences in South Asia balance technology with affordability? • What is the current state of medical device regulation across the region? • How does South Asia's market differ from the more digitally advanced Southeast Asian market? • Which medical device segments are experiencing the fastest growth? • What role is India's 80% import dependency playing in its push for domestic manufacturing? • Where do the biggest opportunities lie for MedTech companies in the coming years? 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 min
  • Unlocking Indonesia: Your MedTech Entry Strategy

    Unlocking Indonesia: Your MedTech Entry Strategy
    Jun 22 2025
    This episode delves into the critical factors for introducing medical devices to the Indonesian market. We cover the regulatory framework, including the role of the Ministry of Health and the necessity of a Local Authorized Representative. We also discuss device classification, licensing, extensive documentation requirements like ISO 13485 and CSDT, labeling in Bahasa Indonesia/English, the new Halal certification mandate from January 2023, import restrictions, taxes, post-market surveillance, and license validity. Practical advice is offered to help manufacturers navigate this complex landscape. Key Questions: • What is the role of Indonesia's NADFC/BPOM in medical device registration? • Why is a Local Authorized Representative essential for foreign manufacturers in Indonesia? • How does device classification (Class A-D) impact your market entry strategy? • What are the key documents needed for the CSDT dossier, including ISO 13485? • What are the language and labeling requirements for medical devices in Indonesia? • Is Halal certification now mandatory for medical devices in Indonesia, and since when? • What import restrictions and taxes should manufacturers anticipate? • What are the post-market surveillance obligations in Indonesia? • How long are medical device licenses valid in Indonesia and what's the renewal process? 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 min
  • U.S. MedTech Marketing: Navigating FDA & FTC Rules

    U.S. MedTech Marketing: Navigating FDA & FTC Rules
    Jun 21 2025
    This episode delves into the essential U.S. regulations governing medical device marketing and advertising. We explore the roles of the FDA and FTC, key requirements for truthful and substantiated claims, the prohibition of off-label promotion, and how device classification impacts oversight. Learn about navigating online advertising, social media compliance, and the potential consequences of non-adherence, ensuring your promotional activities are both effective and lawful. Key Questions: • What are the primary goals of U.S. medical device marketing regulations? • How do the roles of the FDA and FTC differ in overseeing medical device advertising? • What constitutes a "restricted" versus a "non-restricted" medical device, and how does this affect marketing rules? • What kind of evidence is required to substantiate marketing claims for medical devices? • Is it permissible to promote a medical device for uses not approved by the FDA? • How should risks and benefits be presented in medical device advertising? • What are the specific considerations for advertising medical devices on social media? • What are the potential penalties for non-compliant medical device marketing in the U.S.? • How can companies ensure their marketing materials meet regulatory standards before publication? 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 min
  • Unlocking Markets: Navigating Medical Device Certifications

    Unlocking Markets: Navigating Medical Device Certifications
    Jun 20 2025
    This episode provides a comprehensive overview of the critical certification requirements for medical devices across key global markets. We explore the significance of ISO 13485 for quality management, the process of obtaining CE marking for European Union access, and the various FDA pathways for the United States market, along with other country-specific certifications. Understanding these frameworks is crucial for ensuring device safety, quality, and successful international market entry. Key Questions: • What is the role of ISO 13485 in global medical device compliance? • How does CE marking open doors to the European Union market? • What are the different FDA approval pathways for medical devices in the USA? • Are there specific certifications required for In-Vitro Diagnostic (IVD) devices? • Why is understanding country-specific regulations vital for global expansion? • How can robust certification strategies build trust and ensure regulatory acceptance? • What are the key steps involved in obtaining CE marking or FDA approval? • Do all medical devices require the same level of scrutiny for certification? 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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    6 min
  • EU Market Entry: Mastering CE Marking for Medical Devices

    EU Market Entry: Mastering CE Marking for Medical Devices
    Jun 19 2025
    This episode provides a comprehensive guide to CE Marking for medical devices, a mandatory certification for accessing the European Economic Area. We cover the essential requirements, including device classification, Quality Management Systems, technical documentation, conformity assessments by Notified Bodies, clinical evaluations, the role of the EU Authorized Representative, and post-market surveillance. Learn about the benefits, such as expanded market access and enhanced patient safety, as well as key considerations like ongoing compliance under regulations like MDR 2017/745 and IVDR 2017/746. Key Questions: • What is CE Marking and why is it essential for medical devices in Europe? • How does the EU's Medical Device Regulation (MDR 2017/745) impact CE certification? • What are the different risk classifications for medical devices and how do they affect the CE process? • What is the role of a Notified Body in obtaining CE Marking? • What key documentation, like the Technical File and Clinical Evaluation Report, is required? • Do non-EEA manufacturers need a European Authorized Representative? • What are the ongoing responsibilities after a device receives its CE mark? • How does CE Marking contribute to patient safety and broader market access? 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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    5 min