x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

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

03:28

EU Legacy Devices: Navigating the 'Significant...

Medical Device Global Market Access ·

2026/02/03

This episode delves into the critical definition of a "significant change" for legacy medical devices and IVDs under the EU MDR and IVDR. We explore the official MDCG guidance, outlining what types of modifications can end a device's transitional grace period, forcing an early and costly move to full certification. Learn about the high-stakes impact on market access and the importance of a robust change control process.- What is a "legacy device" and what are the new transition timelines? - How

en

03:21

Beyond the Barcode: Mastering MedTech UDI for EUDAMED...

Medical Device Global Market Access ·

2026/02/02

This episode delves into the complex realities of Unique Device Identification (UDI) strategy for medical devices. The host explores common blockers that go beyond simple barcode generation, including the nuanced rules for UDI assignment across different packaging configurations, the challenges of carrier placement, and the critical importance of database submission readiness for platforms like EUDAMED. We uncover why mistakes in UDI can cascade into significant traceability and recall issues, and

en

03:41

EU MDR Vigilance & Trend Reporting: A Deep Dive into...

Medical Device Global Market Access ·

2026/02/01

This episode explores the critical operational hotspots in medical device vigilance under regulations like the EU MDR. We examine the pressures for faster, higher-quality incident investigations, the complexities of making accurate MDR reportability decisions, and the nuances of establishing effective trend reporting thresholds. Discover how these vigilance activities are directly linked to your CAPA system, FSCA decisions, and the overall credibility of your Post-Market Surveillance (PMS) system

en

03:13

Beyond the Plan: Mastering PMS and PMCF Execution...

Medical Device Global Market Access ·

2026/01/31

This episode explores the critical shift in regulatory focus from Post-Market Surveillance (PMS) planning to execution. We discuss why Notified Bodies and regulators, particularly under the EU MDR, are no longer accepting PMS and Post-Market Clinical Follow-up (PMCF) as a paperwork exercise. Learn about the concept of a “silent nonconformity” and how a weak, poorly executed surveillance strategy can lead to major issues during surveillance audits and certificate renewals, jeopardizing your market

en

03:08

EU MDR Clinical Evidence: Mastering CERs, PMCF, and...

Medical Device Global Market Access ·

2026/01/30

This episode delves into the stringent clinical evidence requirements under the European Union's Medical Device Regulation (MDR 2017/745). We explore the top challenges manufacturers face, including the heightened standards for clinical evaluation plans and reports (CEPs/CERs), the complexities of justifying 'sufficient data,' the difficulties in making equivalence arguments, and the continuous nature of Post-Market Clinical Follow-up (PMCF).Key Questions - What does "sufficient clinical evidence"

en

03:02

EU MDR & IVDR Certification: Navigating the Notified...

Medical Device Global Market Access ·

2026/01/29

This episode delves into the ongoing Notified Body capacity crisis for EU MDR and IVDR certification. Despite extended transition deadlines, significant bottlenecks in audit scheduling and technical documentation review are creating a "timeline compression" risk. We explore why manufacturers must strategically prioritize their product portfolios and engage with Notified Bodies much earlier than planned to avoid jeopardizing market access as deadlines approach.- Why is Notified Body availability

en

02:59

EU MDR & IVDR Simplification: What the 2025 Proposal...

Medical Device Global Market Access ·

2026/01/28

This episode unpacks the European Commission's significant proposal of December 16, 2025, aimed at the targeted simplification of the MDR and IVDR. We explore the potential impacts on documentation, digitalization through EUDAMED, and what these changes could mean for manufacturers, especially SMEs, as they navigate the complex European regulatory landscape.Key Questions: - What specific changes are included in the EU Commission's "targeted simplification" proposal? - How could the proposed

en

02:44

EU Supply Chain Alert: Navigating Medical Device...

Medical Device Global Market Access ·

2026/01/27

This episode unpacks the critical amendments introduced by Regulation (EU) 2024/1860, focusing on the new obligations for medical device manufacturers to notify authorities about supply interruptions and discontinuations. We explore why this has become a major compliance challenge, touching on its impact on portfolio management, distributor relations, and the necessity for early risk detection systems to prevent shortages and ensure market stability in the European Union.- What are the new supply

en

02:57

EU IVDR Extension: Key Conditions & Deadlines Under...

Medical Device Global Market Access ·

2026/01/26

This episode details the crucial extension of the In-Vitro Diagnostic Regulation (IVDR) transition periods under the EU's Regulation 2024/1860. We explore the specific, time-sensitive conditions manufacturers must meet to benefit from this extension, including Quality Management System requirements and mandatory engagement with a Notified Body. This is essential information for any IVD manufacturer looking to maintain market access in the European Union. - What is Regulation (EU) 2024/1860 and how

en

03:08

The EUDAMED Clock is Ticking: Understanding the EU's...

Medical Device Global Market Access ·

2026/01/25

This episode details the crucial update on the EUDAMED gradual roll-out. We explain the impact of the European Commission's Implementing Decision (EU) 2025/2371, which confirms the functionality of the first four EUDAMED modules. The discussion covers which modules are now live, the official start date for mandatory use—May 28, 2026—and what actions medical device and IVD manufacturers must take to ensure compliance for market access in the European Union. Key Questions: - What is Commission

en

03:24

COFEPRIS Uncovered: Comparing Mexico's Device...

Medical Device Global Market Access ·

2026/01/24

This episode provides a detailed overview of Mexico's three-tiered medical device classification system managed by COFEPRIS. We explore how Class I, Class II, and Class III devices are defined by risk and highlight the key differences between Mexico's framework and the systems used by the US FDA and the European Union. Understanding these nuances is the critical first step for successful market entry. - How does Mexico's COFEPRIS classify medical devices? - What are the three risk-based classes for

en

03:04

MFDS to COFEPRIS: Why Your Korean Medical Device...

Medical Device Global Market Access ·

2026/01/23

This episode details the critical error of applying South Korea's four-tier MFDS medical device classification directly to Mexico's three-tier COFEPRIS registration system. We explain why the differing regulatory frameworks, classification rules, and risk criteria make a direct transfer impossible and discuss the severe consequences of such a mistake, including immediate rejection, costly delays, and reputational damage with the regulatory authority.- Why is it a mistake to use a Korean device

en

02:47

Korean Devices in Mexico: Mastering COFEPRIS...

Medical Device Global Market Access ·

2026/01/22

This episode focuses on the critical regulatory hurdles Korean medical device companies face when entering the Mexican market. We delve into the specifics of COFEPRIS's three-tier classification system, highlighting its key differences from Korea's four-class MFDS framework. Listeners will learn why misclassification is a primary cause of submission rejections and how a strategic approach to device grouping can significantly reduce registration costs and timelines, ensuring a smoother and more

en

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

en

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

en

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

en

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

en

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

en

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

en

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

en

311 results

Similar Podcasts

Lead With AI

Tamara Nall

Linux in the Ham Shack

Black Sparrow Media

Data Engineering Podcast

Tobias Macey

Eye On A.I.

Craig S. Smith

Reflections

Livewire Labs