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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

02:44

ANVISA's Gateway to Brazil: Why Korean MFDS Approval...

Medical Device Global Market Access ·

2026/01/14

This episode delves into the single most critical requirement for Korean medical device manufacturers entering the Brazilian market: providing proof of country of origin market authorization. We explain why Brazil's ANVISA requires official approval from Korea's Ministry of Food and Drug Safety (MFDS) and how this documentation serves as vital evidence of a device's safety and efficacy. We also explore the direct impact that your domestic regulatory timeline in Korea has on your ability to access

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03:01

Brazil's INMETRO Certification: A Guide for Korean...

Medical Device Global Market Access ·

2026/01/13

This episode focuses on a critical regulatory hurdle for Korean medical device companies entering the Brazilian market: the mandatory INMETRO certification for electro-medical devices. We break down why this certification, which requires local testing in Brazil, is often an unexpected challenge for manufacturers accustomed to the MFDS system. We cover the specific devices affected, the typical timelines of three to twelve months, and the ongoing costs associated with maintenance audits, providing a

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02:47

Cracking the Code: Brazil's Complex Import Taxes for...

Medical Device Global Market Access ·

2026/01/12

This episode delves into the single most significant barrier for Korean medical device manufacturers entering the Brazilian market: the intricate and burdensome import taxation system. We break down the multiple federal and state-level taxes—including II, IPI, PIS, COFINS, and ICMS—that can collectively exceed 60% of a product's value, and explain why a nuanced understanding of landed costs and product classification is essential for success.- Why is Brazil's import tax system so challenging for

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02:51

Brazil's ANVISA: The Portuguese Language Barrier for...

Medical Device Global Market Access ·

2026/01/11

This episode details the single most critical challenge for Korean medical device manufacturers entering Brazil: ANVISA's strict Portuguese-only documentation requirement. We explore why this is a major hurdle, how it differs from Korea's MFDS policies, and the significant risks of improper translation, including costly delays and registration failures.Key Questions: - Why is entering the Brazilian market uniquely challenging for Korean medical device companies? - What is ANVISA's strictest

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02:43

Korean MedTech in Brazil: Navigating ANVISA's B-GMP...

Medical Device Global Market Access ·

2026/01/10

This episode unpacks the most critical step for Korean medical device companies entering the Brazilian market: ANVISA's Brazilian GMP (B-GMP) certification. We detail the mandatory B-GMP requirements for Class III and IV devices and compare the two main compliance pathways. Discover the significant time and cost advantages of leveraging MDSAP certification, which can extend certificate validity to four years and potentially waive on-site inspections, versus the timeline and costs associated with a

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02:51

Korean MedTech in Brazil: Unlocking ANVISA Approval...

Medical Device Global Market Access ·

2026/01/09

This episode explores the single most critical regulatory requirement for Korean medical device companies entering the Brazilian market: the mandatory appointment of a Brazilian Registration Holder (BRH). We delve into why foreign companies cannot register directly with ANVISA, contrast Brazil's system with Korea's MFDS, and outline the extensive legal and operational responsibilities of a BRH, from registration and GMP inspections to post-market surveillance. Learn why selecting the right local

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03:34

EU MDR Clinical Investigations: Navigating Deadlines...

Medical Device Global Market Access ·

2026/01/08

This episode provides a detailed overview of the clinical investigation requirements under the European Union's Medical Device Regulation (MDR). We explore the critical distinctions between pre-market clinical investigations and post-market clinical follow-up (PMCF), the role of the Clinical Evaluation Report (CER) as a living document, and the key transitional deadlines that manufacturers of legacy devices must meet to maintain market access. We also touch on the function of the EUDAMED database in

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02:57

Navigating COFEPRIS: A Guide to Dental Device...

Medical Device Global Market Access ·

2026/01/07

This episode provides a comprehensive guide to the regulatory landscape for dental devices in Mexico. We delve into the role of the national regulatory body, COFEPRIS, and explore the classification system for dental equipment and supplies. The discussion covers the essential requirements for market entry, including the mandatory appointment of a Mexican Registration Holder (MRH), the different registration pathways available—such as the Standard and Equivalency routes—and the critical importance of

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03:01

Accessing Mexico's Dental Market: A Guide to COFEPRIS...

Medical Device Global Market Access ·

2026/01/06

This episode provides a detailed guide for dental device manufacturers on navigating the regulatory landscape in Mexico. We cover the role of the national authority, COFEPRIS, the critical process of appointing a Mexico Registration Holder (MRH), device classification, and the strategic advantages of using the Equivalency Pathway for faster market approval. We also discuss essential post-market obligations, including Technovigilance and registration renewal.- What is the role of COFEPRIS in

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03:21

COFEPRIS Approval: Your Strategy for the Mexican...

Medical Device Global Market Access ·

2026/01/05

This episode explores the strategic pathway for bringing dental devices to the Mexican market. We delve into the regulatory framework managed by COFEPRIS, the risk-based device classification system, and the critical role of a local partner or Mexican Registration Holder (MRH). Learn how leveraging existing approvals from the USA, Canada, or Japan can create an efficient entry strategy and what post-market responsibilities are essential for maintaining compliance. - What makes Mexico an attractive

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03:22

Navigating Mexico's IVD Market: COFEPRIS Compliance...

Medical Device Global Market Access ·

2026/01/04

This episode explores the strategic necessity for In-Vitro Diagnostic (IVD) manufacturers to partner with specialized, full-service distributors when entering the Mexican market. We discuss the regulatory landscape governed by COFEPRIS, the critical role of the Mexican Registration Holder (MRH), and how an integrated distributor model not only facilitates market entry but also provides essential post-market support, including installation, maintenance, and navigating recent regulatory updates like

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03:00

Mexico's IVD Market: Mastering COFEPRIS & Distributor...

Medical Device Global Market Access ·

2026/01/03

This episode explores the process of entering Mexico's In-Vitro Diagnostics (IVD) market. We examine the regulatory landscape managed by COFEPRIS, the critical role of a Mexico Registration Holder (MRH), and the strategic implications of choosing a local partner. Using the prominent distributor DIAC as an example, we differentiate between the regulatory and commercial functions essential for success in this major Latin American market.- What is COFEPRIS and how does it regulate IVD devices in

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03:25

Mexico's IVD Market Expansion: A Distributor Strategy...

Medical Device Global Market Access ·

2026/01/02

This episode explores the pivotal role of local distributors in Mexico's burgeoning in-vitro diagnostics (IVD) market, using Proveedor Integral de Diagnóstico (PIDSA) as a case study. We analyze how specialized distributors provide essential infrastructure, including cold chain logistics and technical support, to help foreign medical device manufacturers successfully navigate and access the growing Mexican clinical laboratory sector.- What is the projected value of Mexico's clinical diagnostics

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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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311 results

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