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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

03:55

The African MedTech Market: Your 2025 Growth and...

Medical Device Global Market Access ·

2025/07/02

Africa's medical device market is set for major growth in 2025, but what's truly driving this expansion? This episode explores the latest market size projections, the key factors fueling demand, and the critical infrastructural and regulatory challenges that MedTech companies must navigate. We dissect whether Africa is the industry's next frontier or a complex web of risks and rewards, providing a data-driven outlook for the coming years.Key Questions: • What are the reliable market size and

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03:18

The Asian MedTech Frontier: Seizing Opportunity in a...

Medical Device Global Market Access ·

2025/07/01

This episode explores the burgeoning medical device market in South and Southeast Asia, a key segment of the high-growth APAC region. We analyze the market size, key drivers like government policy and digital transformation, and the immense potential of powerhouse nations like India and the unified ASEAN bloc. We also dissect the primary challenges, from regulatory fragmentation to pricing pressures, offering a clear view of what it takes to succeed in this dynamic frontier.Key Questions: • How

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03:17

MedTech Compliance 101: Your Guide to Entering Global...

Medical Device Global Market Access ·

2025/06/30

This episode provides a foundational guide for MedTech companies looking to export their devices. We break down the essential first steps of global regulatory compliance, from understanding device classification and risk levels to implementing a robust Quality Management System (QMS) based on ISO 13485. We’ll also touch on the specific requirements of major markets like the United States (FDA) and the European Union (EU MDR).Key Questions: • What is the absolute first step before exporting a

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03:41

Unlocking Market Access: A Guide to Clinical...

Medical Device Global Market Access ·

2025/06/29

This episode demystifies the essential processes of Clinical Evaluation and Clinical Investigation under the EU's Medical Device Regulation (MDR). We break down the entire lifecycle, from creating a Clinical Evaluation Plan (CEP) and gathering sufficient clinical data to compiling the Clinical Evaluation Report (CER) and executing Post-Market Clinical Follow-up (PMCF) to ensure long-term safety and performance. • What is a Clinical Evaluation, and why is it a continuous process? • When can you use

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03:34

From Dossier to Dominance: Mastering Pre-Market...

Medical Device Global Market Access ·

2025/06/28

This episode breaks down the essential pre-market requirements for medical devices, from compiling robust technical documentation to navigating the distinct submission pathways in major global markets. We explore the critical components of a design dossier, including the 510(k), PMA, and CE marking processes, and offer strategies for efficient device grouping and dossier management. • What are the foundational elements of technical documentation for a medical device? • How do EU MDR requirements

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03:50

FDA's New QMSR: A Practical Guide to Harmonization...

Medical Device Global Market Access ·

2025/06/27

This episode unpacks the FDA's new Quality Management System Regulation (QMSR), a landmark change that harmonizes U.S. medical device regulations with the international standard ISO 13485:2016. We cover the specifics of the final rule issued on February 2, 2024, the critical transition timeline ending on February 2, 2026, and the key differences manufacturers must address. Learn about the new requirements for records, labeling, packaging, and how the QMSR will fundamentally change FDA inspections

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03:20

FDA vs. EU: Decoding Medical Device Risk and...

Medical Device Global Market Access ·

2025/06/26

This episode demystifies the critical process of medical device classification in the US and EU. Learn the principles behind risk-based classification and how it directly impacts your path to market, from documentation to regulatory scrutiny.Key Questions: • What are the three medical device risk classes in the United States? • How does the EU's four-class system (I, IIa, IIb, III) differ from the FDA's? • Why is a device's classification the single most important factor for its regulatory

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03:18

The Gatekeepers of Global MedTech: Decoding the FDA,...

Medical Device Global Market Access ·

2025/06/25

This episode demystifies the world's leading medical device regulatory bodies. We break down the distinct structures, approval pathways, and critical requirements of the FDA (USA), the EMA (EU), and the NMPA (China), providing the essential knowledge needed to begin crafting a global market strategy.Key Questions: • What are the fundamental differences between the FDA's centralized system and the EMA's Notified Body approach? • How does a device's risk classification impact its path to market in

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03:02

From Stressed to Prepared: A Guide to Acing MedTech...

Medical Device Global Market Access ·

2025/06/24

This episode provides a comprehensive, step-by-step guide to achieving and maintaining medical device audit readiness. The host outlines how to move beyond last-minute preparation by embedding a culture of quality and compliance into your daily operations. Key topics include implementing a robust QMS, conducting proactive internal audits, leveraging technology for documentation, and managing the audit process from preparation to post-audit actions. Key Questions: • How can you transform audit

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03:24

South Asia's MedTech Surge: A Guide to Market Trends...

Medical Device Global Market Access ·

2025/06/23

This episode provides a comprehensive overview of the South Asian medical device market, highlighting key growth drivers, market size projections, and regulatory trends. We explore the unique dynamics of countries like India, Pakistan, and Bangladesh, comparing the region's trajectory with that of Southeast Asia and identifying the most promising sectors for manufacturers and investors. • How large will the South Asian medical device market be by 2025? • What key factors are fueling the rapid

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03:23

Unlocking Indonesia: Your MedTech Entry Strategy

Medical Device Global Market Access ·

2025/06/22

This episode delves into the critical factors for introducing medical devices to the Indonesian market. We cover the regulatory framework, including the role of the Ministry of Health and the necessity of a Local Authorized Representative. We also discuss device classification, licensing, extensive documentation requirements like ISO 13485 and CSDT, labeling in Bahasa Indonesia/English, the new Halal certification mandate from January 2023, import restrictions, taxes, post-market surveillance, and

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03:53

U.S. MedTech Marketing: Navigating FDA & FTC Rules

Medical Device Global Market Access ·

2025/06/21

This episode delves into the essential U.S. regulations governing medical device marketing and advertising. We explore the roles of the FDA and FTC, key requirements for truthful and substantiated claims, the prohibition of off-label promotion, and how device classification impacts oversight. Learn about navigating online advertising, social media compliance, and the potential consequences of non-adherence, ensuring your promotional activities are both effective and lawful.Key Questions: • What

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05:38

Unlocking Markets: Navigating Medical Device...

Medical Device Global Market Access ·

2025/06/20

This episode provides a comprehensive overview of the critical certification requirements for medical devices across key global markets. We explore the significance of ISO 13485 for quality management, the process of obtaining CE marking for European Union access, and the various FDA pathways for the United States market, along with other country-specific certifications. Understanding these frameworks is crucial for ensuring device safety, quality, and successful international market entry.Key

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05:03

EU Market Entry: Mastering CE Marking for Medical...

Medical Device Global Market Access ·

2025/06/19

This episode provides a comprehensive guide to CE Marking for medical devices, a mandatory certification for accessing the European Economic Area. We cover the essential requirements, including device classification, Quality Management Systems, technical documentation, conformity assessments by Notified Bodies, clinical evaluations, the role of the EU Authorized Representative, and post-market surveillance. Learn about the benefits, such as expanded market access and enhanced patient safety, as well

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03:29

Decoding FDA Medical Device Pathways

Medical Device Global Market Access ·

2025/06/18

This episode provides a comprehensive overview of the U.S. FDA's medical device approval process. We break down the three device risk classifications, detail the primary regulatory pathways including Premarket Notification (510(k)), Premarket Approval (PMA), De Novo, and Humanitarian Device Exemption (HDE). Listeners will also learn about the general steps from device conception to market, typical timelines for each class, and key considerations for manufacturers seeking FDA clearance or

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03:32

Decoding MedTech Regulations: QMSR, ISO 13485 &...

Medical Device Global Market Access ·

2025/06/17

This episode unpacks the evolving world of medical device regulatory compliance. We explore crucial updates, including the FDA's QMSR Final Rule effective February 2026 and its alignment with ISO 13485:2016. We also cover diverse global frameworks, core compliance components like QMS and risk management, common challenges, and strategic approaches to ensure market success while prioritizing patient safety.Key Questions: • What is the significance of the FDA’s QMSR Final Rule for medical device

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04:26

Wearable Health: Revolutionizing Patient Care and...

Medical Device Global Market Access ·

2025/06/16

This episode explores the dynamic field of wearable medical devices. The host discusses the various types, from smartwatches to specialized sensors, their key functions in monitoring, screening, detection, and prediction, and the significant benefits they offer for patient empowerment, remote care, and chronic disease management. The discussion also covers critical challenges like data accuracy, privacy, and system integration, while looking towards future advancements driven by AI and IoMT. Key

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04:41

2024-2025 MedTech Frontier: Devices Changing Patient...

Medical Device Global Market Access ·

2025/06/15

This episode explores the cutting-edge medical device technologies set to revolutionize healthcare in 2024 and 2025. We delve into advancements in noninvasive wearables, home care systems, surgical tools, AI-driven diagnostics, and specialized treatments for cardiovascular, orthopedic, and neurological conditions, highlighting how these innovations are paving the way for more personalized, efficient, and patient-centric care. Key Questions: • What are the most exciting wearable health monitors

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03:05

Protect & Prosper: Insurance Essentials for US MedTech

Medical Device Global Market Access ·

2025/06/14

This episode delves into the critical role of insurance for medical device companies in the USA. We explore the two main facets: securing product liability insurance to mitigate operational and legal risks, and navigating the health insurance reimbursement landscape to ensure patient access and commercial viability. We cover key steps like FDA approval, coding, coverage determination by payers including Medicare and Medicaid, and the importance of demonstrating clinical and economic value.Key

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03:28

Navigating US Health Data Privacy: Is Your Device...

Medical Device Global Market Access ·

2025/06/13

This episode demystifies "HIPAA compliance" for medical devices. The host explores when manufacturers become subject to HIPAA, the essential administrative, physical, and technical safeguards for protecting patient health information (PHI), patient rights regarding their data, requirements for data sharing and Business Associate Agreements, and the critical role of ongoing cybersecurity. Key considerations and common misconceptions about HIPAA applicability are also discussed.Key Questions: • What

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260 results

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