エピソード

  • Your Blueprint for Global MedTech Compliance

    Your Blueprint for Global MedTech Compliance
    2025/09/29
    Choosing the right international standards is a critical strategic decision for any medical device manufacturer. This episode provides a clear framework for navigating the complex world of MedTech standards, starting with the foundational requirements for quality management (ISO 13485), risk management (ISO 14971), and software (IEC 62304). We explore how to build upon this core to select device-specific standards that ensure safety, efficacy, and smoother regulatory submissions worldwide, including the latest implications of the FDA's alignment with ISO 13485. Key Questions: • Which single standard forms the bedrock of a global medical device Quality Management System? • How will the FDA’s new rule, effective February 2, 2026, change quality system requirements in the US? • What is the required process for systematically identifying and controlling device risks for regulators? • If your device has software, which standard is absolutely essential for compliance? • Why is the ISO 10993 series on biocompatibility critical for ensuring patient safety? • How do you move beyond foundational standards to select ones specific to your device's technology, like sterilization or usability? • What are the strategic benefits of integrating standards compliance early in the design 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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    4 分
  • Is Your MedTech Firm Ready for Europe? Avoiding Critical EU MDR Pitfalls

    Is Your MedTech Firm Ready for Europe? Avoiding Critical EU MDR Pitfalls
    2025/09/28
    This episode delves into the most common and costly mistakes medical technology companies make when seeking EU MDR compliance. We break down the complexities of technical documentation, clinical evidence requirements, risk management, and post-market surveillance, offering actionable strategies to avoid these pitfalls, streamline your submission process, and prevent significant delays and rejections from Notified Bodies. Key Questions: • Is your technical documentation truly 'reviewer-ready'? • Are you underestimating the new bar for clinical evidence under the MDR? • Does your risk management file accurately reflect your device's entire lifecycle? • Is your Post-Market Surveillance (PMS) plan proactive or just reactive? • How can you avoid the most common reasons for Notified Body pushback? • What makes a Clinical Evaluation Report (CER) robust enough for the MDR? • Are inconsistencies in your documentation putting your submission at risk? 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 分
  • Regulatory Foresight: A Blueprint for Global MedTech Success

    Regulatory Foresight: A Blueprint for Global MedTech Success
    2025/09/27
    This episode provides MedTech innovators with a foundational blueprint for embedding a global regulatory strategy into their product development process from the very beginning. We explore why a reactive, market-by-market approach fails and outline the critical early-stage decisions in market selection, quality management, and clinical evidence that pave the way for faster, more efficient international market access. Key Questions: • Why is a 'launch and learn' regulatory approach so risky for new devices? • How can early market selection influence your core product design? • What is the single most important standard to build your global strategy upon? • How do you design a clinical trial to satisfy multiple global regulators simultaneously? • What are the hidden costs of ignoring labeling and translation requirements until the last minute? • How has the EU MDR changed the game for clinical evidence worldwide? • When should you really start budgeting for global regulatory submissions? 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 分
  • Local Reps, Global Reach: The Unseen Gatekeepers of MedTech Access

    Local Reps, Global Reach: The Unseen Gatekeepers of MedTech Access
    2025/09/26
    This episode explores the critical, often mandatory, role of in-country representatives for medical device manufacturers entering foreign markets. We cover their functions from initial product registration and labeling to post-market vigilance and adverse event reporting. The episode also highlights the strategic pitfalls of using a distributor as a representative and the benefits of appointing an independent professional to maintain control and flexibility. • What is an in-country representative and why is it mandatory in most markets? • How does a local representative facilitate the product registration process? • What are their legal responsibilities for post-market surveillance and vigilance? • Why could appointing your distributor as your representative be a costly mistake? • How does an independent representative give you more control over your business? • What information must be included on the product labeling regarding the representative? • Who do national authorities contact if there is a safety issue with your device? • How can you switch distributors without having to re-register your product? 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 分
  • UAE MedTech Approval: Decoding the MOHAP Process

    UAE MedTech Approval: Decoding the MOHAP Process
    2025/09/25
    This episode demystifies the medical device approval process in the United Arab Emirates. We explain the central role of the Ministry of Health and Prevention (MOHAP), the mandatory manufacturer registration, and how the formal risk-based classification system (Classes I-IV) dictates your entire path to market, from evidence requirements to review timelines. Key Questions: • Who is the single regulatory authority for medical devices in the UAE? • What is the first step a manufacturer must take before submitting a product for approval? • How does the UAE classify medical devices based on risk? • Why is receiving a formal risk classification from MOHAP so critical for your submission strategy? • What does your device's classification determine about your evidence and documentation requirements? • How do international approvals like CE marking influence the UAE process? • What is the typical validity period for a medical device registration certificate in the UAE? 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 分
  • UAE MedTech Approval: Your MOHAP Dossier and Simplified Pathway Guide

    UAE MedTech Approval: Your MOHAP Dossier and Simplified Pathway Guide
    2025/09/25
    This episode breaks down the essential documentation required for medical device registration with the UAE's Ministry of Health and Prevention (MOHAP). We explore the complete technical dossier, from the Free Sale Certificate and ISO 13485 to bilingual labeling and clinical data. A key focus is clarifying the "simplified pathway" for devices with prior CE or FDA approval, explaining how it impacts the review process without reducing the amount of paperwork required for a successful submission. Key Questions: • What is the UAE's key regulatory authority for medical devices? • What core documents are required in a MOHAP technical dossier? • Do device labels and instructions need to be in Arabic? • Can a prior CE Mark or FDA clearance get you to the UAE market faster? • What does the "simplified pathway" for MOHAP registration really mean? • Do you still need to submit a full technical file even with prior FDA/CE approval? • Why is robust clinical and risk data non-negotiable for the UAE? 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 分
  • The Gatekeeper: Unlocking the UAE MedTech Market with the Right Local Partner

    The Gatekeeper: Unlocking the UAE MedTech Market with the Right Local Partner
    2025/09/25
    This episode delves into the mandatory requirement for a Local Authorized Representative (LAR) when bringing a medical device to the United Arab Emirates market. We explore the critical functions of the LAR as the interface with the Ministry of Health and Prevention (MOHAP), their legal responsibilities for product registration and post-market vigilance, and the strategic importance of selecting an independent representative over a commercial distributor. Key Questions: • Is a local representative mandatory for selling medical devices in the UAE? • What are the core responsibilities of a Local Authorized Representative (LAR)? • Who legally holds the medical device registration license in the UAE? • How does an LAR interact with the UAE's Ministry of Health and Prevention (MOHAP)? • What is the LAR's role in post-market surveillance, vigilance, and recalls? • What are the risks of appointing a commercial distributor as your authorized representative? • Why is selecting an LAR a critical strategic decision for market access and control? • Can you change distributors if your device registration is held by them? 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 分
  • UAE Regulatory Overhaul: Unpacking Federal Decree-Law 38 for MedTech

    UAE Regulatory Overhaul: Unpacking Federal Decree-Law 38 for MedTech
    2025/09/24
    This episode delves into the landmark changes introduced by the UAE's Federal Decree-Law 38 of 2024, which took effect on January 2, 2025. We explore the creation of the new Emirates Drug Establishment (EDE), the critical new requirements for importers and distributors, and what the one-year grace period means for medical device manufacturers looking to enter or remain in the UAE market. • What is the new Federal Decree-Law 38 of 2024 and when does it become effective? • How does the new Emirates Drug Establishment (EDE) change the regulatory landscape in the UAE? • What specific new rules apply to Marketing Authorisation Holders regarding importers and distributors? • Are both pharmaceuticals and medical devices now governed by the same law? • How long is the grace period for companies to comply with the new regulations? • What key areas, like contracts and quality systems, must be updated before the January 2, 2026 deadline? • Why is the UAE making these significant changes to its regulatory framework? 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 分