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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

03:13

Medical Imaging & Radiology in Mexico: The Medical...

Medical Device Global Market Access ·

2026/01/01

This episode explores Mexico's medical device market through a profile of Medical Prado, a leading distributor for medical imaging and radiology equipment. We analyze their role as an authorized Mindray dealer, the value-added services they provide, and their strategic focus on key regions like CDMX, Edomex, and Jalisco. This case study offers crucial insights for MedTech manufacturers aiming to understand the importance of local distribution partnerships for successful market entry in Mexico.-

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02:51

Partnering for Success: Navigating Mexico's Medical...

Medical Device Global Market Access ·

2025/12/31

This episode explores the strategic advantages of partnering with specialized local distributors to enter Mexico's medical imaging and radiology market. We analyze the case of XRG Especialidades Médicas, a distributor with over 25 years of experience, to understand how their model of providing turnkey solutions, sales, and after-sales service helps foreign manufacturers navigate regulatory complexities with COFEPRIS and achieve sustainable market penetration.- What makes Mexico an attractive

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02:43

Mexico's Radiology Market: A Distributor's Role with...

Medical Device Global Market Access ·

2025/12/30

This episode explores the intricacies of Mexico's medical imaging and radiology market. We focus on the crucial role of local distributors by examining IMADINE, an authorized partner for global giants like Agfa and Philips. We discuss their portfolio, which includes ultrasound, X-ray, CT, and MRI equipment, and their value-added services such as site selection support and procurement assistance for Mexican healthcare facilities. This is a must-listen for any MedTech manufacturer considering entry or

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03:17

Unlocking Mexico: A Strategic Guide to Orthopedic &...

Medical Device Global Market Access ·

2025/12/29

This episode explores the strategic nuances of entering Mexico's orthopedic and trauma medical device market. We analyze the successful distribution model of DAONSA Implantes, a key player that partners with global brands like ConMed and Enovis. We discuss how their focus on specialized clinical support, surgeon education, and workflow integration provides a powerful blueprint for foreign manufacturers seeking to penetrate and thrive in the complex Mexican healthcare landscape.- What makes Mexico

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03:08

COFEPRIS Registration & Market Strategy for...

Medical Device Global Market Access ·

2025/12/28

This episode explores the strategic importance of local partnerships for medical device market access in Mexico, using orthopedic and trauma device distributor IMTRA as a case study. We discuss the role of the Mexican regulatory authority, COFEPRIS, the necessity of holding local registrations, and how a specialized distributor provides essential commercial and technical support to succeed in this key Latin American market.Key Questions - What is COFEPRIS and why is it critical for selling medical

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03:29

Mexico's Orthopedic Implants Market: Navigating...

Medical Device Global Market Access ·

2025/12/27

This episode explores Mexico's dynamic orthopedic and trauma device market, detailing its significant growth drivers, including medical tourism and an expanding private healthcare sector. We provide a clear overview of the regulatory landscape managed by COFEPRIS, including device classification, the crucial role of a Mexican Registration Holder (MRH), and the equivalency pathway for faster market access. We also highlight the indispensable role of experienced local distributors, using the 40-year

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03:01

Mexico Market Access: The Role of Specialized...

Medical Device Global Market Access ·

2025/12/26

This episode examines the strategic importance of specialized local distributors for medical device market access, using DPM Distribuidores de Productos Médicos in Mexico as a case study. We explore how DPM's focus on interventional cardiology and radiology provides a crucial advantage for manufacturers entering the complex Mexican healthcare market.- Why is a specialized distributor essential for niche medical devices? - What specific clinical areas does DPM focus on in Mexico? - How can a local

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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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258 results

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