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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

03:21

Accessing Mexico’s MedTech Scene: A Case Study in...

Medical Device Global Market Access ·

2025/12/25

This episode explores Mexico's advanced medical device market through a case study of Endomédica, a leading distributor in interventional cardiology and radiology. We analyze how their specialized focus, clinical support, and integrated solutions model make them a key player and an ideal partner for international manufacturers seeking to enter the dynamic Latin American market.- What makes Mexico a strategic market for advanced medical devices? - How does a specialized distributor operate in the

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03:17

Mexico's COFEPRIS Approval: Fast-Tracking Cardiology...

Medical Device Global Market Access ·

2025/12/24

This episode explores the lucrative Mexican market for interventional cardiology and radiology devices, detailing the COFEPRIS registration process. We cover the mandatory appointment of a Mexico Registration Holder (MRH), device classification, and the critical differences between the standard and expedited Equivalency Pathways. Learn how leveraging prior approvals from the US, Canada, or Japan can fast-track your market entry and what key regulatory changes are coming in 2025.- What is COFEPRIS

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03:04

Brazil's Dental Market: Unlocking Access with Key...

Medical Device Global Market Access ·

2025/12/23

This episode explores Brazil's lucrative dental device market, highlighting the critical role of established local distributors for successful market entry. We focus on Dental Speed, a principal distributor founded in 1996, as a case study to understand how strategic partnerships are essential for navigating Brazil's complex regulatory landscape, managed by ANVISA, and achieving commercial success through effective sales channels like e-commerce and telesales.- Why is Brazil a critical market for

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02:54

Brazil's Dental Market: Unlocking Access with Dental...

Medical Device Global Market Access ·

2025/12/22

This episode provides a deep dive into Dental Cremer, a Henry Schein company, and its dominant role in the Brazilian dental device market. We explore how its massive e-commerce platform, sophisticated nationwide logistics, and unique financing options create a powerful distribution channel. For international MedTech manufacturers, understanding Dental Cremer's strategy is crucial for successfully navigating market entry and expansion in Latin America's largest economy. Key Questions: - Who is

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03:16

Brazil's Diagnostic Imaging Boom: Navigating Market...

Medical Device Global Market Access ·

2025/12/21

This episode explores Brazil's rapidly growing diagnostic imaging market, a key area for global MedTech companies like Philips Healthcare. We analyze the market's projected growth to USD 1.73 billion by 2030, the primary drivers behind this expansion, and the significant impact of ANVISA's June 2024 regulatory changes, which now recognize approvals from the US, Canada, Japan, and Australia. The discussion covers the opportunities and persistent challenges, such as import dependency and the demand

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02:57

Siemens Healthineers: AI, CT, and Cardiology Imaging...

Medical Device Global Market Access ·

2025/12/20

This episode explores Siemens Healthineers' significant role in Brazil's diagnostic imaging market. We cover their extensive portfolio of CT, MR, angiography, and ultrasound systems, their strategic expansion into diverse regions of the country, and their focus on integrating advanced technologies like Artificial Intelligence. Learn about specific innovations for radiology and cardiology, such as the AI-Rad Companion and the TrueFusion imaging system for complex cardiac procedures. - How is Siemens

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02:57

GE HealthCare's Brazil Strategy: Localizing...

Medical Device Global Market Access ·

2025/12/19

This episode delves into GE HealthCare's strategic investment in Brazil, examining the establishment of its first diagnostic imaging manufacturing facility in South America. We explore the timeline, from the 2008 announcement to the 2010 factory opening in Contagem, and analyze the "In Latin America, For Latin America" initiative. The discussion covers the types of equipment produced, such as X-ray, CT, and MRI systems, and the broader impact on the Brazilian healthcare market, including increased

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04:05

DePuy Synthes in Brazil: Navigating ANVISA's RDC...

Medical Device Global Market Access ·

2025/12/18

This episode examines the Brazilian market for orthopedic medical devices, using DePuy Synthes (a J&J MedTech company) as a case study. We break down the essential regulatory requirements set by ANVISA, including the pivotal RDC 751/2022 resolution, device classification, the mandatory Brazilian Registration Holder (BRH), and Good Manufacturing Practice (B-GMP) certification. Learn how a global leader successfully navigates one of Latin America's most challenging yet rewarding markets.Key

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03:11

Zimmer Biomet in Brazil: A Blueprint for Orthopedic...

Medical Device Global Market Access ·

2025/12/17

This episode explores the strategic pathway for medical device market entry into Brazil, the largest MedTech market in Latin America. We analyze the case of Zimmer Biomet Brasil Ltda. to illustrate the critical importance of establishing a local subsidiary, securing a Brazil Registration Holder (BRH), and navigating the complex regulatory landscape governed by ANVISA, including requirements like Brazilian Good Manufacturing Practice (BGMP) and INMETRO certification.- What makes Brazil an

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03:17

Cracking the Brazilian Market: How Stryker Dominates...

Medical Device Global Market Access ·

2025/12/16

This episode examines Stryker do Brasil's successful strategy for dominating the Brazilian orthopedics market. We explore their extensive national distributor network, the specific product lines covered, and how their transparent, service-oriented approach provides crucial support to surgical teams, offering a powerful case study for medical device manufacturers looking to penetrate complex international markets.Key Questions: - How does a MedTech giant like Stryker structure its distribution in a

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03:13

Unlocking the Brazilian MedTech Market: ANVISA's...

Medical Device Global Market Access ·

2025/12/15

This episode explores the lucrative but complex medical device market in Brazil, the largest in Latin America. Using Abbott's Cardiac Rhythm Management (CRM) division as a practical example, we break down the critical regulatory requirements for high-risk devices. We cover the role of the national authority, ANVISA, the essential RDC 751/2022 regulation, the mandatory Brazilian Registration Holder (BRH) system, and the stringent Brazilian Good Manufacturing Practice (B-GMP) certification. We also

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02:56

Brazil Market Access: Boston Scientific's Cardiology...

Medical Device Global Market Access ·

2025/12/14

This episode explores the strategic approach of Boston Scientific in the Brazilian medical device market, focusing on its cardiology and electrophysiology operations. We analyze how Boston Scientific do Brasil functions as a local wholesale trader, supports key product portfolios like stents and balloons, and leverages global resources for physician education and supply chain continuity. Learn how this multinational giant combines local presence with global strength to succeed in Brazil's complex

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02:49

Brazil MedTech Market: A Medtronic Cardiology Case...

Medical Device Global Market Access ·

2025/12/13

This episode analyzes how Medtronic has achieved long-term success in Brazil's complex cardiology device market. We explore their strategy of combining product distribution with extensive clinical support and training to navigate regulatory hurdles and a dual healthcare system, a model established since their entry in 1971.- How did Medtronic build a 50-year legacy in the Brazilian cardiology market? - What is the role of a local subsidiary in navigating ANVISA's regulations? - Why is clinical

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02:59

Global MedTech Expansion: Key Strategies for Market...

Medical Device Global Market Access ·

2025/12/12

This episode breaks down the core components of a successful global market access strategy for MedTech and IVD companies. We explore the importance of building a proactive regulatory roadmap, the challenges of tailoring technical dossiers for different international markets like the US, EU, and Asia, and the critical role of local representation and post-market surveillance in maintaining compliance. Learn how modern AI-driven tools can streamline submissions and help you navigate the complex web of

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03:20

McKesson's 2025 Spin-Off: A New Era for US Medical...

Medical Device Global Market Access ·

2025/12/11

This episode delves into McKesson's major announcement from May 2025 to spin off its Medical-Surgical Solutions (MMS) division into a new, independent company. We explore the strategic rationale behind this decision and what it means for the US medical device distribution landscape. We analyze the specific role of MMS in serving alternate-site providers like physician offices and surgery centers and discuss the significant implications this separation will have for MedTech manufacturers focused on

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02:22

Cardinal Health's GMPD: A Deep Dive into US Medical...

Medical Device Global Market Access ·

2025/12/10

This episode provides a detailed analysis of Cardinal Health's Global Medical Products & Distribution (GMPD) segment, a dominant force in the U.S. medical supply market. We explore its business model, recent financial performance through FY2024 and FY2025, and its strategic importance for healthcare providers. The discussion covers how its private-label brands and national logistics network make it a top-tier distribution partner for cost-conscious and quality-focused sourcing strategies in

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02:34

The Medline Advantage: U.S. Market Dominance and a...

Medical Device Global Market Access ·

2025/12/09

This episode explores Medline Industries, the top medical-surgical distributor in the United States. We uncover the immense scale of its operations, its unique business model that combines distribution with in-house manufacturing, and the significant details surrounding its upcoming high-profile IPO planned for 2025, which is poised to be one of the year's largest listings.- What makes Medline the number one medical-surgical distributor in the U.S.? - How does Medline's manufacturing of its own

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02:53

The US Hearing Aid Boom: Decoding the FDA's OTC Rule...

Medical Device Global Market Access ·

2025/12/08

This episode explores the transformation of the U.S. hearing aid market following the FDA's landmark 2022 rule that established an over-the-counter (OTC) category. We analyze the impact on accessibility, device innovation, and affordability, while also examining the continued importance of the prescription hearing aid channel. The discussion covers early market analyses from 2024 and the outlook for 2025, highlighting the factors that make hearing aids a key medical device category. - What was the

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02:51

CPAP & APAP Technology: Navigating the Booming US...

Medical Device Global Market Access ·

2025/12/07

This episode explores the robust and growing U.S. market for Continuous Positive Airway Pressure (CPAP) and Automatic Positive Airway Pressure (APAP) devices used to treat obstructive sleep apnea (OSA). We delve into the key factors driving sustained, double-digit demand, including the high prevalence of OSA among American adults. The discussion also covers the maturation of the clinical and payer ecosystem, which now better supports long-term patient adherence through innovations like home sleep

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03:00

Pacemakers and ICDs in 2024-2025: Key Global Market...

Medical Device Global Market Access ·

2025/12/06

This episode explores the dynamic landscape of Cardiac Implantable Electronic Devices (CIEDs), including pacemakers, ICDs, and CRT devices. We discuss why these devices are now a routine therapy, driven by an aging population and technological advancements. We cover key innovations like leadless technology, remote monitoring, and MRI-conditional labeling, and examine market trends for 2024-2025, including conduction-system pacing, highlighting how these devices remain a cornerstone of modern

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311 results

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