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.
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    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.
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    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.
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    3 min
  • From China to Brazil: Navigating ANVISA without NMPA Reliance

    From China to Brazil: Navigating ANVISA without NMPA Reliance
    Sep 6 2025
    This episode clarifies whether a medical device approved by China's NMPA can benefit from an expedited registration process with Brazil's ANVISA. We detail the full Brazilian regulatory requirements, including classification, the role of a Brazil Registration Holder (BRH), B-GMP certification, and the AREE program, explaining why NMPA approval doesn't currently offer a shortcut. • Can my Chinese NMPA approval speed up device registration in Brazil? • What is the AREE program, and which countries does ANVISA recognize for faster review? • What are the two main registration pathways for medical devices in Brazil? • Why is a Brazilian Registration Holder (BRH) mandatory for foreign manufacturers? • Do all medical devices require a Brazilian Good Manufacturing Practice (B-GMP) certificate? • What is the key regulation that governs medical device classification and registration in Brazil? • What are INMETRO and ANATEL certifications, and when are they required? • What is the difference between the *Notificação* and *Registro* pathways? • Does having MDSAP certification replace the need for a B-GMP audit? 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
  • From Brazil to the US: Unpacking ANVISA and FDA 510(k) Pathways

    From Brazil to the US: Unpacking ANVISA and FDA 510(k) Pathways
    Sep 5 2025
    This episode tackles a common question from MedTech manufacturers: can a successful ANVISA registration in Brazil streamline the path to FDA 510(k) clearance in the United States? We explore the reality of regulatory reliance between these two key markets, clarifying the one-way nature of current frameworks and outlining how your existing ANVISA technical documentation can still provide a significant advantage for your US submission. • Does the FDA recognize or have a reliance pathway for ANVISA-approved medical devices? • What is Brazil's new "Reliance" program (IN 290/2024) and how does it affect US manufacturers? • Can the technical dossier created for ANVISA be used for an FDA 510(k) submission? • What are the fundamental differences between an ANVISA registration and an FDA 510(k)? • How does the concept of a "predicate device" make the 510(k) process unique? • Can my BGMP (Brazilian Good Manufacturing Practices) certification help with FDA QSR compliance? • What parts of my ANVISA submission, like clinical data and risk analysis, can be repurposed? • What are the critical gaps I need to fill when moving from a Brazilian approval to a US submission? 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
  • From NMPA to CE Mark: Bridging the Regulatory Gap

    From NMPA to CE Mark: Bridging the Regulatory Gap
    Sep 4 2025
    This episode breaks down the essential differences between China's NMPA approval and the EU's rigorous MDR CE marking process. We explore the key gaps in regulatory philosophy, clinical data requirements, and post-market surveillance that manufacturers must bridge to expand from the Chinese to the European market. Key Questions: • Is my NMPA approval enough to get a CE mark in Europe? • What is the difference between a Notified Body and the NMPA? • How do EU MDR requirements for a Clinical Evaluation Report (CER) differ from China's? • Why is Post-Market Surveillance (PMS) more demanding under the EU MDR? • What is a Person Responsible for Regulatory Compliance (PRRC) and do I need one? • How does the approach to the Quality Management System (QMS) vary between the two regions? • Can I reuse my technical documentation from China for my EU submission? 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
  • From Tokyo to Brussels: Navigating the EU MDR After Japan Shonin

    From Tokyo to Brussels: Navigating the EU MDR After Japan Shonin
    Sep 3 2025
    Securing Shonin approval in Japan is a huge regulatory achievement, but it doesn’t guarantee a simple path to the European market. This episode breaks down the key differences between Japan's PMD Act and the EU's demanding Medical Device Regulation (MDR). We explore the critical gaps manufacturers must address in their Quality Management System, technical documentation, clinical evidence, and post-market surveillance strategies to successfully obtain a CE Mark. Key Questions: • Can I reuse my Japanese technical documentation for my CE Mark application? • Why is the EU's Clinical Evaluation Report (CER) more demanding than Japanese requirements? • What is a Periodic Safety Update Report (PSUR) and do I need one for Europe? • How does a Japanese Marketing Authorization Holder (MAH) differ from an EU Authorised Representative? • Is my Japanese QMS automatically compliant with EU standards? • What are the biggest hurdles when moving from the Japanese market to the EU? • Does Shonin approval shorten the timeline for getting an EU CE Mark? 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 NMPA to FDA: Leveraging China Approval for U.S. Market Entry

    From NMPA to FDA: Leveraging China Approval for U.S. Market Entry
    Sep 3 2025
    This episode details the process for medical device manufacturers to obtain FDA 510(k) clearance in the United States after securing Class III approval from China's NMPA. We explain that there is no direct reciprocity and outline how to strategically leverage existing Chinese technical documentation, clinical data, and testing reports. The focus is on conducting a thorough gap analysis to meet the FDA's unique requirements, particularly the concept of "substantial equivalence" to a predicate device and compliance with 21 CFR Part 820 for quality management systems. • Does my NMPA Class III approval guarantee FDA clearance? • How can I use my clinical trial data from China for an FDA submission? • What is a "predicate device" and why is it crucial for a 510(k)? • Do I need to repeat all my device testing for the U.S. market? • What are the key differences between China's GMP and the FDA's Quality System Regulation? • What is a gap analysis and why is it the most critical step? • Is it mandatory to submit my 510(k) electronically? • What is a U.S. Agent and do I need to have one? 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