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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

02:55

From Lab to Life: The Rise of Bioactive 3D-Printed...

Medical Device Global Market Access ·

2025/07/20

This episode delves into the revolutionary world of personalized 3D-printed spinal implants, highlighting Xenco Medical's TrabeculeX Continuum. We explore how its bioactive matrix eliminates the need for painful bone grafts, significantly reducing surgery time, and how its integrated recovery app is transforming postoperative care through remote monitoring and high patient engagement.Key Questions: • How can 3D printing revolutionize spinal implant surgery? • What are bioactive materials and how

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03:03

The Remote Revolution: How At-Home Devices Are...

Medical Device Global Market Access ·

2025/07/19

This episode explores the rise of remote physical therapy devices like ROMTech's PortableConnect as a direct response to the significant shortage of physical therapists in the United States. We analyze the market drivers, patient benefits, and the critical market access hurdles, including payer reimbursement, that innovative MedTech companies face when introducing disruptive technologies. Key Questions: • What does the latest data from October 2024 reveal about the physical therapist shortage in

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03:05

From Niche to Mainstream: The AI Revolution in...

Medical Device Global Market Access ·

2025/07/19

This episode explores the rapid expansion of AI-integrated wearables, focusing on how continuous glucose monitors (CGMs) are transitioning from clinical devices to mainstream wellness tools. We delve into the technological drivers, such as advanced sensors and on-device AI, and the market catalysts, including the 2024 Medicare coverage expansion, that are fueling a 25.53% CAGR in the wearable medtech market. • How are wearables evolving from simple trackers to predictive health monitors? • Why are

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02:50

AI and the Heart: How 3D Modeling is Transforming...

Medical Device Global Market Access ·

2025/07/18

This episode delves into the revolutionary HeartFlow platform, an AI-powered diagnostic tool that creates personalized 3D models of the heart from CT scans. We explore how this technology is transforming the diagnosis of coronary artery disease by offering a non-invasive, highly accurate alternative to traditional methods, its key regulatory milestones with the FDA, and its rapid adoption in leading U.S. hospitals.Key Questions: • How can artificial intelligence create a 3D digital twin of a

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02:58

KIMES 2025: Your Gateway to South Korea's High-Tech...

Medical Device Global Market Access ·

2025/07/17

This episode explores South Korea's dynamic medical device market, providing a strategic preview of the upcoming Korea International Medical & Hospital Equipment Show (KIMES) in March 2025. We analyze the key growth trends, including the rapid adoption of AI in diagnostic imaging and the boom in portable and wearable health technologies. The discussion covers market drivers like the aging population and high-tech consumer base, while also outlining the regulatory landscape governed by the MFDS and

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03:12

Guangzhou 2024: Inside China's 5G Smart Hospital...

Medical Device Global Market Access ·

2025/07/16

This episode dives into the upcoming Greater Bay Area International Medical Device Expo in Guangzhou, China, scheduled for September 23-25. We explore the event's core themes of "Smart Hospitals" and "5G Medical Ecology," detailing how these trends are shaping the future of MedTech in one of the world's most dynamic economic zones. This is a must-listen for professionals seeking to understand and penetrate the advanced Chinese healthcare market.Key Questions: • What makes China's Greater Bay Area

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02:29

Inside Riyadh's 2024 Global Health Exhibition: Your...

Medical Device Global Market Access ·

2025/07/15

This episode dives into the 2024 Global Health Exhibition in Riyadh, the largest healthcare event in Saudi Arabia. We explore how this event serves as a crucial gateway for medical device companies looking to capitalize on the Kingdom's Vision 2030, focusing on opportunities in government procurement, high-end equipment imports, and partnerships driven by massive national investment in healthcare transformation.• Why is the Global Health Exhibition a must-attend event for MedTech in 2024? • How is

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02:50

Your Gateway to Japan's Healthcare Market: Navigating...

Medical Device Global Market Access ·

2025/07/14

This episode provides a detailed guide to the upcoming MEDICAL JAPAN trade show in Tokyo, a vital event for MedTech companies targeting the Japanese and Asian markets. We explore the event's scale, the diverse sectors it covers, and the strategic opportunities it offers for networking, partnerships, and market entry. Key Questions: • What is MEDICAL JAPAN and why is it considered a gateway to Asia's healthcare industry? • When and where will the MEDICAL JAPAN 2025 Tokyo event take place? • How many

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02:32

Accessing Latin America: Key Insights from Hospitalar...

Medical Device Global Market Access ·

2025/07/14

This episode unpacks Hospitalar 2024, the most influential healthcare trade fair in Latin America. We explore the key trends, market demands, and strategic opportunities that emerged from the event in São Paulo, Brazil, providing essential insights for any MedTech company targeting the region. • What makes Hospitalar the most important healthcare event in Latin America? • What were the key technology and product trends on display from May 21-24, 2024? • How does the event cater to both basic and

en

02:58

Arab Health 2025: Your Strategic Gateway to the MENA...

Medical Device Global Market Access ·

2025/07/13

This episode explores the immense strategic importance of the Arab Health exhibition, taking place in Dubai from January 27-30, 2025. We delve into why this event is the premier gateway for medical device companies, particularly those in high-end imaging, to access the rapidly growing Middle East and North Africa (MENA) market. Discover the key trends, the scale of the opportunity, and how to effectively prepare for this critical industry gathering.Key Questions: • What makes Arab Health the

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02:52

Decoding CMEF 2025: Your Gateway to China's MedTech Boom

Medical Device Global Market Access ·

2025/07/12

The China International Medical Equipment Fair (CMEF) in Shanghai is the premier gateway to the Asia-Pacific's booming MedTech sector. This episode offers a deep dive into the upcoming 2025 event, exploring its massive scale, dual focus on primary and high-end care, and its unique role in integrating the entire industry supply chain. We highlight the surge in domestic innovation, from surgical robots to advanced imaging, and explain why the new manufacturing technology section is a game-changer for

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04:11

One Audit, Six Markets? MDSAP vs. ISO 13485 in...

Medical Device Global Market Access ·

2025/07/11

We explore the Quality Management System requirements for medical device manufacturers in six key Southeast Asian markets: Singapore, Malaysia, Vietnam, the Philippines, Thailand, and Indonesia. The episode details the mandatory ISO 13485 standard and clarifies where the Medical Device Single Audit Program (MDSAP) is, and importantly, where it isn't, a valid substitute for market access.Key Questions: • What is the fundamental difference between ISO 13485 and an MDSAP audit? • Is ISO 13485

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03:02

Unlocking Global Opportunities at MEDICA 2024

Medical Device Global Market Access ·

2025/07/10

This episode provides a comprehensive guide to MEDICA 2024 in Düsseldorf, the world's leading trade fair for the medical technology industry. We explore the event's massive scale, its key focus areas, the hot topics for this year like AI and digital health, and why it is a critical event for any company looking to succeed in the global MedTech market.Key Questions: • What makes MEDICA the most important medical trade fair in the world? • When and where will MEDICA 2024 take place? • What are the

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03:20

The Titans of MedTech: A Guide to the World's 3...

Medical Device Global Market Access ·

2025/07/09

This episode unpacks the three largest and most influential medical device trade shows on the planet. We explore the unique characteristics of MEDICA in Germany, Arab Health in Dubai, and CMEF in China, providing medical device professionals with the essential intelligence needed to strategically plan their global outreach, networking, and market expansion efforts.Key Questions: • Which European trade show is considered the largest in the world for medical technology? • What makes Arab Health a

en

02:36

Unlocking the Malaysian Medical Device Market: A 2024...

Medical Device Global Market Access ·

2025/07/08

This episode provides a detailed guide to Malaysia's medical device registration process. We explore the role of the Medical Device Authority (MDA), the foundational Medical Device Act 2012, and the critical steps manufacturers must take, from risk classification and conformity assessments to submission via the MeDC@St online system, including recent 2024 updates.• What is the primary legislation governing medical devices in Malaysia? • How does the risk classification (A, B, C, D) impact your

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03:53

Brazil's New MedTech Timeline: Understanding ANVISA...

Medical Device Global Market Access ·

2025/07/07

This episode provides a detailed overview of the medical device registration process in Brazil under the new RDC 751/2022 regulation. We explore the two primary regulatory pathways, Notificação and Registro, their associated timelines, and the structure of official ANVISA fees. Learn about the critical role of risk classification and Brazilian Good Manufacturing Practice (B-GMP) certification for successful market entry. Key Questions: • What is the new key regulation for medical devices in Brazil

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03:06

Malaysia MedTech: The Risks and Rewards of...

Medical Device Global Market Access ·

2025/07/06

This episode delves into the strategic option for foreign MedTech companies to use their own Malaysian subsidiary as the official license holder for their medical devices. We unpack the regulatory framework under the Medical Device Act 2012, highlighting the complete control this model offers over registrations and commercial activities. However, it also brings significant legal and operational responsibilities, including mandatory GDPMD certification and full liability for post-market surveillance

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03:19

Cracking COFEPRIS: The Critical Stages After Your...

Medical Device Global Market Access ·

2025/07/05

This episode demystifies the complex journey a medical device registration takes in Mexico *after* the initial dossier is submitted to COFEPRIS. We explore the critical post-submission phases, from the initial review and the dreaded 'prevención' (request for information) to the final certificate issuance and vital post-market responsibilities. Learn about the different review pathways, including the Standard, Equivalency, and Third-Party Reviewer (TPR) routes, and understand the crucial steps needed

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03:13

Beyond the Hospital: The Rise of Long-Term Care Devices

Medical Device Global Market Access ·

2025/07/04

This episode delves into the rapidly growing Long-Term Care (LTC) market, explaining what it is, the demographic shifts driving its expansion, and its critical link to the medical device industry. We explore the evolution from basic equipment to advanced technologies like IoT, remote patient monitoring, and AI, highlighting the future trends and opportunities for MedTech manufacturers.• What is Long-Term Care (LTC) and why is it becoming a critical healthcare sector? • What global demographic

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03:56

Beyond the Great Wall: Unlocking China's Medical...

Medical Device Global Market Access ·

2025/07/03

China's medical device market is poised for significant growth leading into 2025, driven by an aging population and government initiatives like "Healthy China 2030." However, foreign manufacturers face new challenges, including fierce local competition, pro-domestic procurement policies, and the complexities of the NMPA regulatory system. This episode breaks down the market outlook for 2025, exploring the key drivers, the critical challenges, and the localized strategies required to succeed in this

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260 results

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