Episodes

  • UAE Regulatory Overhaul: Unpacking Federal Decree-Law 38 for MedTech

    UAE Regulatory Overhaul: Unpacking Federal Decree-Law 38 for MedTech
    Sep 24 2025
    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.
    Show More Show Less
    3 mins
  • UAE MedTech Market Entry: A Guide to Timelines and Costs

    UAE MedTech Market Entry: A Guide to Timelines and Costs
    Sep 23 2025
    This episode provides a detailed breakdown of the timelines and costs associated with registering a medical device in the United Arab Emirates. We explore the two main regulatory pathways, the specific government fees in AED, and the often-overlooked indirect costs like translation and notarization that manufacturers must budget for. We also break down the review timelines based on MOHAP’s risk classification system. Key Questions: • What is the first step for any manufacturer entering the UAE market? • How does the device risk class affect the MOHAP review timeline? • What are the specific government fees in Emirati Dirhams for device registration? • Are there different regulatory pathways for professional-use versus home-use devices? • What are the "hidden costs" that can impact your budget? • How long is a medical device registration certificate valid for in the UAE? • Who is the primary regulatory authority for medical devices 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.
    Show More Show Less
    3 mins
  • Beyond the Sale: The Critical Role of MedTech Service and Logistics

    Beyond the Sale: The Critical Role of MedTech Service and Logistics
    Sep 22 2025
    A successful product launch goes far beyond the initial sale. For manufacturers of high-complexity analyzers and consumables, the true test of a distribution partner lies in their logistical prowess and service support infrastructure. This episode explores the essential, non-negotiable support functions that ensure your device not only reaches the customer but operates reliably to meet the demanding uptime requirements of modern clinical laboratories. Key Questions: • Does your distribution strategy account for the entire product lifecycle? • How vital is unbroken cold-chain logistics for your reagents and consumables? • What does on-site installation and performance validation truly entail for complex instruments? • Can your support network provide immediate, 24-hour technical assistance to a lab in crisis? • Is your distributor equipped with the warehousing and field-service engineers needed to guarantee nationwide uptime? • How quickly can you deliver critical replacement parts to any clinical lab? • Are you prepared to meet the stringent uptime and quality standards mandated by regulations like the Clinical Laboratory Improvement Amendments (CLIA) of 1988? 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.
    Show More Show Less
    3 mins
  • Distributor Contracts: Your Performance Shield or a Risky Gamble?

    Distributor Contracts: Your Performance Shield or a Risky Gamble?
    Sep 22 2025
    This episode dives into the critical components of medical device distributor agreements that protect manufacturers from underperformance. We explore how to structure contracts with specific Key Performance Indicators (KPIs) and robust termination clauses, turning your agreement into a tool for accountability and market success, rather than a liability. • How can an exclusive distributor agreement backfire and trap your product? • What are the most effective KPIs to include beyond simple sales numbers? • Why should you define targets for marketing spend and demo placements? • What specific performance failures should trigger a termination clause? • How can you structure a termination clause that is both fair and firm? • What is a "cure period" and why is it essential for a healthy partnership? • How do you ensure your distributor's sales team is properly trained and certified? • What other triggers, like insolvency, should be included in your agreement? 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.
    Show More Show Less
    3 mins
  • U.S. Agent vs. Initial Importer: A Critical Choice for FDA Import Success

    U.S. Agent vs. Initial Importer: A Critical Choice for FDA Import Success
    Sep 21 2025
    This episode demystifies the distinct and critical roles of the FDA U.S. Agent and the Initial Importer for medical device manufacturers entering the U.S. market. We explore the specific regulatory responsibilities of each, highlighting why appointing a distributor without proven compliance expertise can jeopardize your import success and post-market standing. • What is the fundamental difference between an FDA U.S. Agent and an Initial Importer? • Who is legally responsible for reporting adverse device events to the FDA? • Can your distributor also act as your Initial Importer? • What are the risks of choosing an Initial Importer without proven regulatory processes? • Which entity is responsible for verifying a device's 510(k) or PMA status upon import? • How do these roles directly impact whether your shipments clear U.S. customs? • What specific post-market surveillance duties does an Initial Importer have? • Why is this distinction crucial for maintaining compliance once your device is in the U.S. market? 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.
    Show More Show Less
    3 mins
  • The Distributor Mismatch: Finding Your IVD's Champion in the U.S. Market

    The Distributor Mismatch: Finding Your IVD's Champion in the U.S. Market
    Sep 20 2025
    Choosing the right U.S. distributor is a make-or-break decision for IVD manufacturers. This episode moves beyond big names to focus on the critical importance of aligning with a distributor's specific customer focus and sales structure. We explore why understanding "call points"—whether in hospital labs, reference labs, or physician offices—and ensuring a distributor will dedicate resources to champion your new device are non-negotiable steps for a successful market launch. • What are "call points" and why do they determine your product's success? • Is your potential distributor a strategic partner or just a logistics provider? • How can you ensure your new IVD device won't get lost in a massive product catalog? • Will a distributor allocate dedicated sales reps to champion your new technology? • What tough questions must you ask a distributor before signing any agreement? • Does the distributor's existing portfolio create a conflict of interest for your product? • How do you identify a partner who is genuinely invested in your growth in the U.S. market? 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.
    Show More Show Less
    3 mins
  • From Code to Cash: A Guide to U.S. Medical Device Reimbursement Rates

    From Code to Cash: A Guide to U.S. Medical Device Reimbursement Rates
    Sep 19 2025
    Securing a U.S. medical device code is only half the battle; the next challenge is determining its payment rate. This episode breaks down the three primary pathways for setting reimbursement rates in the United States. We explore the roles of CMS and private payers, detailing the specifics of the cross-walking and gap-filling processes, including key timelines like the annual summer public meetings. We also uncover the most common pitfalls that can delay or diminish your device's earning potential, from unfavorable comparisons to the complexities of negotiating with hundreds of individual payers. Key Questions: * Once a device has a code, how is its reimbursement rate actually set? * What is CMS's "cross-walk" process, and what are its biggest risks? * How does "gap-filling" work for novel technologies without a comparator? * What is the typical timeline for the gap-fill process and when do key decisions happen? * How do private payers determine payment rates, and how does it differ from Medicare? * What are the most common pitfalls that can undervalue a new medical device? * Why is the first year of a new code often financially unpredictable? * How can you build a strategy to navigate both CMS and private payer negotiations? 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.
    Show More Show Less
    3 mins
  • FDA Import Readiness: U.S. Agent vs. Initial Importer Explained

    FDA Import Readiness: U.S. Agent vs. Initial Importer Explained
    Sep 18 2025
    Navigating the FDA's import regulations requires a clear understanding of two critical, yet distinct, roles: the U.S. Agent and the Initial Importer. This episode breaks down their specific responsibilities, explaining how confusing them can lead to costly customs delays and compliance failures. We explore the specific regulatory burdens of the Initial Importer, including Medical Device Reporting and device listing, and highlight why manufacturers must verify their distributor’s capabilities to ensure smooth market entry. • What is the fundamental difference between an FDA U.S. Agent and an Initial Importer? • Why is the U.S. Agent's role primarily administrative and not related to compliance? • What specific regulatory responsibilities, like MDR, does an Initial Importer handle? • How can selecting the wrong Initial Importer halt your device shipments at the border? • What are the most common errors in entry filings related to import roles? • How do you verify if your distributor is truly ready to act as your Initial Importer? • What post-market surveillance duties fall on the Initial Importer? 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.
    Show More Show Less
    3 mins