Page de couverture de Medical Device Global Market Access

Medical Device Global Market Access

Medical Device Global Market Access

Auteur(s): Pure Global
Écouter gratuitement

À propos de cet audio

 Navigate every market. Accelerate every launch. Medical Device Global Market Access by Pure Global is the audio briefing that turns the world’s most confusing regulatory pathways into clear, actionable roadmaps. If you’re a MedTech founder, RA/QA leader, product manager, or investor who needs to get devices cleared anywhere from Austin to Abu Dhabi, this show is your shortcut. Why listen? • Step-by-step playbooks – We decode EU MDR, U.S. 510(k), Brazil’s ANVISA, China’s NMPA, and 25 + other regimes, showing exactly how long each milestone really takes and where companies get stuck. • First-hand war stories – Hear candid interviews with regulatory veterans who have shepherded implants, software, wearables, diagnostics, and AI algorithms to market—and lived to tell the tale. • Real-time intelligence – Every episode covering the week’s new guidances, standards, and enforcement trends so you’re always ahead of the curve. • Actionable templates – From clinical evaluation checklists to technical-file skeletons, we break down the documents you’ll need and the pitfalls reviewers love to flag. • AI-powered insights – Because Pure Global mines millions of public filings, tenders, and recalls, we surface data-backed best practices you won’t hear at conferences—or from competitors. What you’ll hear • Launching SaMD under multiple risk classes in parallel • Surviving an unannounced ISO 13485 audit • Building a “reg-first” QMS that scales • Mastering Latin-American registrations without endless language cycles • Leveraging real-world evidence to shorten clinical timelines • Aligning cybersecurity, privacy, and post-market surveillance rules across regions Whether you’re plotting first entry, managing lifecycle expansions, or rescuing a delayed submission, subscribing could shave months—and millions—off your path to revenue. ⸻ Brought to you by Pure Global – the AI-native consultancy that already guides MedTech innovators through regulatory and market-access hurdles in 30 + countries. Ready for expert help on your next submission? Visit https://pureglobal.com or email info@pureglobal.com to start accelerating today.Copyright 2025 Pure Global
Épisodes
  • Certificate of Free Sale: Who Is Eligible to Apply?

    Certificate of Free Sale: Who Is Eligible to Apply?
    Sep 8 2025
    This episode clarifies the complex eligibility requirements for obtaining a Certificate of Free Sale (FSC) for medical device exports. We dissect the critical differences between the regulatory frameworks in the United States and the European Union, explaining precisely who—from manufacturer to exporter to authorized representative—can legally apply for this essential market access document in each region. Key Questions: • What is a Certificate of Free Sale (FSC) and why do exporters need it? • In the United States, can a distributor or exporter apply directly for an FDA Certificate to Foreign Government (CFG)? • Under the EU's Medical Device Regulation (MDR), who is legally permitted to request a Certificate of Free Sale? • Why are importers and distributors explicitly ineligible to apply for an FSC in Europe? • What is the critical role of an EU Authorized Representative in the FSC application process for non-EU companies? • How did the FDA's process for issuing export certificates change as of January 2024? • What is the key difference between who can apply for an FSC in the US versus the EU? 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.
    Voir plus Voir moins
    3 min
  • Navigating FDA Export Certificates: Timelines, Fees, and 2024 Updates

    Navigating FDA Export Certificates: Timelines, Fees, and 2024 Updates
    Sep 8 2025
    This episode demystifies the process of obtaining a Certificate to Foreign Government (CFG), also known as a Free Sale Certificate (FSC), from the US FDA. We cover the official timelines for issuance, the specific government fees you can expect to pay, and the critical procedural shift to electronic-only certificates that took effect in early 2024. Learn the essential details to plan your international market submissions effectively and avoid costly delays. • What is the official FDA term for a “Free Sale Certificate”? • How long does the FDA have to issue an export certificate once requested? • What is the exact government fee for the first CFG? • How much does each additional certificate from the same request cost? • Is there a page limit that could unexpectedly increase your fees? • What major change did the FDA implement for all export certificates on January 2, 2024? • How can foreign governments now instantly authenticate your certificate? • Why is this certificate a mandatory requirement for market entry in many regions? • How can you efficiently manage product lists to control costs? 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.
    Voir plus Voir moins
    3 min
  • Unlocking the FDA 510(k) with Your Japanese PMDA Approval

    Unlocking the FDA 510(k) with Your Japanese PMDA Approval
    Sep 7 2025
    Many companies believe that getting medical device approval in Japan might fast-track their entry into the U.S. market. This episode breaks down that misconception and reveals the strategic pathway that actually exists. We explore how the FDA’s Abbreviated 510(k) program allows manufacturers to leverage their existing PMDA data, focusing on the crucial role of internationally recognized consensus standards. Learn how this approach can save significant time and resources compared to a traditional submission, without compromising regulatory diligence. Key Questions: • Is there a direct reciprocity agreement between Japan's PMDA and the US FDA for device approvals? • How does an Abbreviated 510(k) submission differ from a Traditional one? • What are "recognized consensus standards," and why are they the key to this strategy? • Can I reuse testing data for biocompatibility and electrical safety from my Japanese submission for the FDA? • What is the Safety and Performance Based Pathway, and how is it related? • Does using the Abbreviated 510(k) program eliminate the need for a predicate device? • How can a declaration of conformity simplify the FDA review process? • What is the most important first step to leveraging a PMDA certification for FDA clearance? 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.
    Voir plus Voir moins
    3 min
Pas encore de commentaire