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PODCAST

Medical Device Global Market Access

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

technology

All Episodes

04:25

ISO 13485 Explained: Your Key to MedTech Compliance...

Medical Device Global Market Access ·

2025/06/12

This episode demystifies ISO 13485 certification, explaining how it signifies a robust Quality Management System for medical device organizations. We explore the certification process, its broad applicability across the device lifecycle, the stringent requirements for risk management and regulatory compliance, and its crucial role in ensuring product safety, facilitating market access, and building stakeholder trust.Key Questions: • What does it truly mean for a medical device company to be "ISO

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05:08

Unlock Global MedTech Markets: Finding Your Ideal...

Medical Device Global Market Access ·

2025/06/11

This episode delves into proven strategies for medical device companies to identify, vet, and secure local importers and distributors worldwide. We explore a multifaceted approach, combining digital tools, key industry events, professional networks, and crucial due diligence steps to help you effectively expand your product's global reach and navigate market entry complexities.Key Questions: • How can specialized online databases supercharge your distributor search? • What is the unique value of

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04:00

The Multi-Billion Dollar Diagnosis: Unpacking...

Medical Device Global Market Access ·

2025/06/10

This episode delves into the dominant force in medical device revenue: In Vitro Diagnostics (IVDs). We uncover why IVDs consistently lead the global market, highlighting key drivers like early disease detection and the rise of chronic illnesses. We also explore the geographical strongholds, with a focus on the U.S. market's supremacy, and identify the leading corporations such as Abbott, Roche, and Siemens Healthineers shaping this lucrative sector. Key Questions: • Which medical device category

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04:18

Beyond EU Bottlenecks: MedTech's New Global Market...

Medical Device Global Market Access ·

2025/06/09

This episode explores the evolving global market entry strategies for medical devices. We discuss the significant regulatory hurdles in the EU due to MDR/IVDR, leading manufacturers to increasingly prioritize the U.S. market. We also delve into the burgeoning opportunities in high-growth emerging markets across Asia-Pacific and Latin America, offering insights into strategic planning for today's complex MedTech landscape. Key Questions: • Why is the EU becoming a less attractive first-launch market

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02:37

MedTech Goes Global: Top 3 Expansion Strategies

Medical Device Global Market Access ·

2025/06/08

This episode delves into the three essential pillars for medical device companies aiming to expand their reach from local to international markets. We discuss the critical nature of understanding diverse international regulatory landscapes and the role of harmonization efforts. We also explore the importance of in-depth market research, effective product localization, and cultural adaptation. Finally, we cover the strategic value of forming local partnerships and developing a robust go-to-market

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04:40

CE Marking: The Golden Key for Global MedTech Entry

Medical Device Global Market Access ·

2025/06/07

CE marking is a crucial certification for medical devices, acting as a legal key to the European market and a global benchmark for safety and quality. It signifies compliance with strict EU regulations (MDR/IVDR), offers competitive advantages, and provides a solid foundation for other international regulatory approvals, making it essential for manufacturers aiming for worldwide market access.Key Questions: • Why is CE marking mandatory for selling medical devices in the 30+ countries of the

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03:29

Decoding High-Risk Medical Device Classifications...

Medical Device Global Market Access ·

2025/06/06

This episode unpacks the significant variations in "Class III" and "Class IV" medical device classifications across key global markets like the US, EU, Canada, China, and Saudi Arabia. We explore why a device's risk class in one country doesn't automatically apply elsewhere and what this means for manufacturers seeking international market access.Key Questions: • Why isn't a Class III device in the USA treated the same as a Class III in the European Union or Canada? • Which major global markets

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05:41

2025 MedTech Fast Track: FDA Breakthroughs & CMS...

Medical Device Global Market Access ·

2025/06/05

This episode unpacks the 2025 landscape for the FDA's Breakthrough Devices Program and the transformative new CMS Transitional Coverage for Emerging Technologies (TCET) pathway. We explore how these initiatives are accelerating device clearance and Medicare coverage, including the impact of over 1,000 Breakthrough designations granted by September 2024 and TCET's August 2024 finalization. We delve into the benefits, eligibility, and current limitations, such as TCET's five-device annual cap and

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04:34

Unlocking Global Markets: SaMD, AI, and Regulatory...

Medical Device Global Market Access ·

2025/06/04

This episode provides a comprehensive guide to navigating the complex global regulatory landscape for Software as a Medical Device (SaMD), with a special focus on AI-enabled technologies. We explore SaMD risk classifications in key markets like the US, EU, and Canada, discuss recent AI-specific guidance from bodies like the FDA (including the December 2024 updates and PCCPs) and MHRA (June 2024 updates), and highlight available fast-track options. We also offer practical strategies for a successful

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05:07

China's 2025 MedTech Surge: NMPA's New Fast-Track for...

Medical Device Global Market Access ·

2025/06/03

This episode delves into China's transformative 2025 NMPA Roadmap, detailing how the "NMPA regulation 2025" aims to accelerate approvals for innovative medical devices. We explore the new Special Review Pathway, shortened clinical trial timelines, priority review categories, and expanded domestic production opportunities, offering insights for manufacturers navigating this evolving regulatory landscape.Key Questions: • What are the headline changes in China's NMPA 2025 roadmap for medical

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03:55

Saudi MedTech Breakthrough: Understanding the SFDA's...

Medical Device Global Market Access ·

2025/06/02

This episode delves into the Saudi Food and Drug Authority’s (SFDA) Innovative Medical Devices Pathway (MDS-G002), a strategic initiative designed to significantly accelerate market entry for novel medical technologies in Saudi Arabia. We explore the key features, eligibility criteria, and the profound impact this pathway has on reducing time-to-market in the Gulf region, fostering local manufacturing under Saudi Vision 2030, and positioning the Kingdom as a MedTech innovation hub. Key Questions: •

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03:21

Brazil's RDC 751/2022: Your 2025 MedTech Compliance...

Medical Device Global Market Access ·

2025/06/01

This episode unpacks Brazil's transformative RDC 751/2022 medical device regulation, effective since March 1, 2023. We cover the updated four-tier risk classification system, the 22 detailed classification rules (including those for SaMD and nanomaterials) aligning with EU MDR, and the distinct Notification (Class I/II) versus Registration (Class III/IV) pathways. Exporters will receive essential compliance tips for 2025, focusing on re-classification, technical documentation, labeling in Brazilian

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03:31

FDA's Landmark QMSR Rule: ISO 13485 Harmonization for...

Medical Device Global Market Access ·

2025/05/31

This episode delves into the U.S. FDA's significant 2024 Quality Management System Regulation (QMSR) final rule. We explore how this rule, effective February 2, 2026, aligns 21 CFR Part 820 with the international standard ISO 13485:2016, discuss key changes, FDA-specific additions, and the crucial steps medical device manufacturers must take to prepare for this transition.Key Questions: • What is the FDA's new Quality Management System Regulation (QMSR) issued on January 31, 2024? • How does the

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04:50

EU MDR's New Timetable: Are You Ready for 2025, 2027,...

Medical Device Global Market Access ·

2025/05/30

This episode delves into the crucial extended transition deadlines for the EU Medical Device Regulation (EU MDR), now set for 2027 and 2028. We explore what these extensions mean for manufacturers of legacy medical devices, emphasizing the critical actions that should have been completed by May and September 2024 to benefit from this extra time. The focus for 2025 shifts from new extension-specific filings to the continuous maintenance of an MDR-compliant Quality Management System, robust

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04:43

EU IVDR: Strengthening Your MedTech Supply Chain...

Medical Device Global Market Access ·

2025/05/29

This episode delves into the critical supply chain requirements for Economic Operators under the EU's In Vitro Diagnostic Regulation (IVDR), referencing insights from April 14, 2025. We explore common pitfalls leading to Notified Body non-conformities, the specific obligations for manufacturers, importers, distributors, and authorized representatives, and strategies for ensuring your quality agreements and operational controls meet the stringent IVDR demands for enhanced traceability and patient

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04:03

Unlocking Worldwide IVD Access with Europe's IVDR

Medical Device Global Market Access ·

2025/05/28

This episode explores how the European Union's stringent In Vitro Diagnostic Devices Regulation (IVDR) can strategically benefit IVD manufacturers seeking market access beyond the EU. We discuss leveraging IVDR CE Marking for easier entry into global markets, the role of harmonized quality management systems like ISO 13485, and the importance of a proactive global market access strategy in light of evolving international regulations, including the US FDA's QMSR effective February 2, 2026, and UK

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04:33

Leveraging Real-World Data: MHRA's Blueprint for...

Medical Device Global Market Access ·

2025/05/27

This episode delves into the UK's Medicines and Healthcare products Regulatory Agency (MHRA) guidance, updated 20 May 2025, on utilizing Real-World Data (RWD) in randomised controlled trials for regulatory decisions. We explore the scope, design considerations, safety monitoring, and regulatory acceptability of RWD-based trials, highlighting their potential to streamline drug development, particularly for label expansions and repurposing existing medicines.Key Questions: • What is the MHRA's

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04:03

Navigating MHRA's 2025 Real-World Data Guidance for...

Medical Device Global Market Access ·

2025/05/26

This episode unpacks the UK MHRA's updated May 20, 2025, guidance on employing Real-World Data (RWD) in clinical studies for regulatory approval. We discuss the scope, the critical emphasis on data quality, essential considerations for sponsors using RWD sources like EHRs and wearables, and how the MHRA is shaping the future of evidence generation for medical products. Key Questions: • What exactly is Real-World Data and how is it changing regulatory submissions? • According to the MHRA's 2025

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05:19

Wireless MedTech: Navigating Global RF Compliance

Medical Device Global Market Access ·

2025/05/25

This episode offers medical device manufacturers an essential overview of navigating global wireless compliance when integrating radio frequency (RF) modules. We explore crucial considerations from selecting RF module suppliers and understanding international certification pathways—like modular versus system-level approvals—to compiling necessary documentation and addressing specific restrictions for medical applications. Learn how early planning and a clear understanding of each target market's

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05:10

Brazil's MedTech Pulse: Fresh Registration Insights...

Medical Device Global Market Access ·

2025/05/23

This episode delves into the latest medical device registration data from Brazil, focusing on trends observed in March and April 2025. We explore the prevalence of Class I and II devices, particularly in diagnostics, the types of higher-risk Class IV devices gaining approval, and the manufacturing landscape, highlighting both strong domestic production and key international players from countries like China, Germany, and the USA. The host discusses specific device categories and the implications for

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