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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

03:06

COFEPRIS & MFDS: A New 30-Day Fast-Track for Korean...

Medical Device Global Market Access ·

2026/01/21

This episode explores the transformative Abbreviated Regulatory Pathway being launched by Mexico's COFEPRIS in September 2025. We detail how this new 30-day process specifically benefits Korean medical device manufacturers holding MFDS approval, outlining the immense opportunity for accelerated market entry. The discussion also covers critical challenges, such as proving product equivalency and navigating submission requirements, to help companies leverage this shortcut effectively.- What is

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03:16

Mexico's COFEPRIS Regulations: A Guide for Korean...

Medical Device Global Market Access ·

2026/01/20

This episode explains the mandatory requirement for foreign medical device manufacturers to appoint a Mexico Registration Holder (MRH) to register products with COFEPRIS. It highlights the specific challenges Korean companies face in finding a reliable partner and the risks of appointing a distributor for this role. The host details how a dedicated, professional MRH provides a secure and compliant pathway to the Mexican market.- What is the single most critical step for Korean MedTech companies

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03:10

Cracking COFEPRIS: Spanish Language Strategy for...

Medical Device Global Market Access ·

2026/01/19

This episode focuses on the single most critical challenge for Korean medical device companies entering the Mexican market: the stringent Spanish language requirements mandated by the regulatory authority, COFEPRIS. We explore how this impacts the entire registration process, from technical documentation to labeling, and why overcoming this linguistic barrier is fundamental for successful market access. Key Questions: - Why is Spanish proficiency the top regulatory hurdle for Korean device

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02:40

Brazil & MERCOSUR: A Strategic Gateway for Korean...

Medical Device Global Market Access ·

2026/01/18

This episode explores why Brazil is a critical entry point for Korean medical device companies looking to expand into South America. We discuss how to leverage Brazil's position within the MERCOSUR trade bloc to access markets like Argentina, Paraguay, and Uruguay, turning a single-country registration into a regional strategy.- Why is Brazil more than just a large domestic market for Korean medical device firms? - What is MERCOSUR and how does it benefit MedTech companies entering South

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02:38

Brazil's SUS & ANVISA: A Guide for Korean MedTech

Medical Device Global Market Access ·

2026/01/17

This episode provides a strategic overview for Korean medical device companies targeting the Brazilian market. We explore the critical process of navigating Brazil's Unified Health System (SUS) to gain market access and secure reimbursement. The discussion covers the key differences between Brazil's public tender process and Korea's HIRA system, recent modernizing changes by ANVISA that impact international companies, and the strategic importance of understanding both the public and private

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02:51

Korea to Brazil: Bridging the Cultural Divide in...

Medical Device Global Market Access ·

2026/01/16

This episode explores the critical cultural challenges Korean medical device companies face when entering the Brazilian market. We delve into why a transactional business approach often fails and highlight the paramount importance of relationship-building, patience, and understanding Brazil's unique business etiquette for a successful market entry.Key Questions - Why do fast-paced Korean business strategies often fail in the Brazilian market? - What is the single most important factor for a

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02:33

Korea to Brazil: Navigating ANVISA's Extended Medical...

Medical Device Global Market Access ·

2026/01/15

This episode explores the significant regulatory hurdles Korean medical device manufacturers face when entering the Brazilian market. We detail the extended approval timelines and unpredictable delays from Brazil's ANVISA, contrasting them with the more streamlined processes of Korea's MFDS. Learn about the different registration pathways for various device classes and the strategic adjustments necessary for a successful market entry.Key Questions: - Why is Brazil's regulatory timeline a major

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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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258 results

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