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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

04:33

From NMPA to FDA: Leveraging China Approval for U.S....

Medical Device Global Market Access ·

2025/09/03

This episode details the process for medical device manufacturers to obtain FDA 510(k) clearance in the United States after securing Class III approval from China's NMPA. We explain that there is no direct reciprocity and outline how to strategically leverage existing Chinese technical documentation, clinical data, and testing reports. The focus is on conducting a thorough gap analysis to meet the FDA's unique requirements, particularly the concept of "substantial equivalence" to a predicate device

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03:27

From Europe to Down Under: A Guide to TGA Approval...

Medical Device Global Market Access ·

2025/09/02

This episode breaks down the process of using your existing European CE Marking to register a medical device in Australia. We cover the essential role of Manufacturer's Evidence, the TGA's application process and timelines, potential audits, and the latest on fees and charges, providing a clear roadmap for MedTech companies looking to enter the Australian market.Key Questions: • What is "Manufacturer's Evidence" and why is it the key to TGA approval? • How does my EU device classification

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03:48

De Novo Submissions: Will Your CE Mark Data Pass FDA...

Medical Device Global Market Access ·

2025/09/01

This episode explores how medical device manufacturers can effectively use their existing CE mark clinical data for an FDA De Novo submission for a novel technology. We delve into the FDA's expectations for foreign data, common gaps between EU and US requirements, and the strategic importance of the Pre-Submission program to de-risk market entry. • Can you directly use your CE mark clinical study for an FDA De Novo submission? • What are the most common data gaps the FDA identifies in European

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03:24

CE Mark to FDA 510(k): A Guide for MedTech Manufacturers

Medical Device Global Market Access ·

2025/08/31

This episode demystifies the process for manufacturers who have an EU CE mark under the MDR and are seeking FDA 510(k) clearance. We break down the crucial differences and similarities between the two regulatory systems, explaining how to leverage existing technical documentation and what new requirements and strategic considerations, like selecting a predicate device, you will face when entering the United States market.Key Questions: • Does an EU CE mark give my device an advantage with the

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03:53

From Europe to Japan: Leveraging Your CE Mark for...

Medical Device Global Market Access ·

2025/08/31

Navigating Japan's rigorous PMDA approval process can be challenging, even for devices that already have a CE mark. This episode demystifies the requirements for a Shonin application, explaining how manufacturers can leverage their existing CE mark data. We break down the critical differences and synergies between the EU and Japanese regulatory systems, from Quality Management Systems and technical documentation to the all-important clinical data requirements and the mandatory role of a local

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03:09

From Europe to Brazil: Bridging the CE Mark and...

Medical Device Global Market Access ·

2025/08/30

This episode demystifies the process of bringing a CE-marked medical device to the Brazilian market. We break down the critical differences between European requirements and Brazil's ANVISA regulations, focusing on the essential documentation, testing, and certification gaps that manufacturers must address for successful registration. • Is a CE mark enough to sell your medical device in Brazil? • What is a Brazil Registration Holder (BRH) and why is it mandatory? • How does ANVISA's technical

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03:22

From MDR to NMPA: A Strategic Guide to China Market...

Medical Device Global Market Access ·

2025/08/29

This episode details the strategic process for transitioning a medical device with a European CE mark under MDR to achieve Class II or III registration with China's NMPA. We break down the unique requirements, from local representation to in-country testing and clinical evaluation pathways, providing a clear roadmap for manufacturers looking to enter the complex but lucrative Chinese market. Key Questions: • Is a CE mark sufficient for selling a medical device in China? • What is a Product

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03:30

Unlocking the Canadian MedTech Market: Beyond the CE...

Medical Device Global Market Access ·

2025/08/28

This episode demystifies the process for CE-marked device manufacturers to obtain a Health Canada Medical Device Establishment Licence (MDEL) for selling in Canada. We break down the crucial differences between an MDEL and a product-specific Medical Device Licence (MDL), clarify who needs to hold an MDEL, and explain why having a CE mark is not a substitute for this essential Canadian requirement. Learn about the key procedural documentation needed for a successful application and the latest

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03:49

From CE to UKCA: Navigating the UK Medical Device...

Medical Device Global Market Access ·

2025/08/28

This episode breaks down the essential steps for medical device manufacturers with a CE mark to comply with UK regulations for Great Britain. We cover the extended deadlines for CE mark recognition, the immediate requirements for MHRA registration and appointing a UK Responsible Person (UKRP), and the process for achieving UKCA conformity assessment. Learn the key dates and actions you need to take to ensure uninterrupted market access.Key Questions: • Is my CE mark still valid for selling medical

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03:25

Cracking the Code: Japan's PMD Act & QMS Requirements

Medical Device Global Market Access ·

2025/08/27

This episode provides a focused guide to Japan's medical device regulations. We explore the relationship between the overarching PMD Act and the detailed QMS requirements of MHLW Ordinance 169. Learn about the crucial 2021 harmonization with ISO 13485:2016, the key differences that remain, and how the Japanese audit process presents unique challenges for foreign manufacturers, including an expanded audit scope and specific documentation demands.Key Questions: • What is the relationship between

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03:19

China's Regulatory Overhaul: Your Guide to NMPA Order...

Medical Device Global Market Access ·

2025/08/26

This episode delves into the landmark revision of China's medical device regulations, State Council Order No. 739, which took effect on June 1, 2021. We break down the critical changes impacting global MedTech manufacturers, from the revolutionary Marketing Authorization Holder (MAH) system to new clinical evaluation pathways and heightened post-market responsibilities. Key Questions: • What is the new Marketing Authorization Holder (MAH) system and how does it change liability? • Can you now use

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03:14

Unlocking the Indian Market: A Guide to the 2017 and...

Medical Device Global Market Access ·

2025/08/25

This episode provides a deep dive into India's Medical Device Rules, 2017, and the subsequent amendments through 2023. We explore the shift to a risk-based classification system, new Quality Management System (QMS) and licensing requirements, and the critical role of the Central Drugs Standard Control Organization (CDSCO). The discussion covers practical implications for manufacturers, including post-market surveillance, vigilance, and the latest 2023 updates to the regulatory framework. • What

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06:04

China's New Electrical Safety Standard: Navigating...

Medical Device Global Market Access ·

2025/08/24

China's new electrical safety standard, GB 9706.1-2020, is now in effect, creating critical deadlines and new requirements for medical device manufacturers. This episode provides a detailed breakdown of the standard, outlining the key changes from the previous version, crucial implementation dates for new and existing products, and the significant impact on market access. We explore the new emphasis on risk management, essential performance, and what you need to do to ensure your devices remain

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03:26

South Korea's Game-Changing 2025 Digital Medical...

Medical Device Global Market Access ·

2025/08/24

This episode unpacks South Korea's pioneering Digital Medical Products Act (DMPA), set to revolutionize the regulatory landscape in January 2025. We explore the act's core components, including its new classification system for digital therapeutics and AI-driven software, the tailored approval processes, and what these changes mean for manufacturers seeking market access.Key Questions: • What is South Korea's new Digital Medical Products Act (DMPA)? • Why is it considered the first comprehensive

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02:55

TGA Approval Down Under: A Guide to the 2002 Medical...

Medical Device Global Market Access ·

2025/08/23

This episode provides a comprehensive overview of Australia's medical device regulations, governed by the Therapeutic Goods Administration (TGA). We explore the Therapeutic Goods (Medical Devices) Regulations 2002, detailing the risk-based classification system, the mandatory Essential Principles for safety and performance, the conformity assessment process, and the critical role of the Australian Register of Therapeutic Goods (ARTG) for market entry. Key Questions: • What is the TGA and what is

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03:22

Decoding NOM-241: Mexico's New GMP Framework for...

Medical Device Global Market Access ·

2025/08/22

This episode unpacks the crucial updates in Mexico's NOM-241-SSA1-2021, the mandatory standard for Good Manufacturing Practices for medical devices. We explore the enhanced Quality Management System (QMS) requirements, the formal inclusion of Software as a Medical Device (SaMD), and the significant decision by COFEPRIS to accept ISO 13485 and MDSAP certifications from foreign manufacturers, streamlining market access.Key Questions: • What is NOM-241-SSA1-2021 and when did it become mandatory for

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02:57

Argentina's MedTech Gateway: Unpacking ANMAT's Key...

Medical Device Global Market Access ·

2025/08/21

This episode demystifies Argentina's medical device registration process under the national regulatory body, ANMAT. We provide a detailed breakdown of the essential framework established by Disposition 9688 of 2019, covering everything from risk classification and registration pathways to the critical requirements for foreign manufacturers seeking market entry.Key Questions: • What is ANMAT Disposition 9688/2019 and why is it essential for MedTech manufacturers? • How does Argentina classify

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03:28

Colombian Market Entry: Your Guide to Decree 4725 and...

Medical Device Global Market Access ·

2025/08/20

This episode provides a comprehensive guide to Colombia's medical device regulations, focusing on the foundational Decree 4725 of 2005 and the role of the regulatory body, INVIMA. We explore the four-tiered risk classification system, the detailed registration process for different device classes, the critical requirement of appointing a local representative, and the importance of post-market surveillance through the Tecnovigilancia program.Key Questions: • What is the foundational law for medical

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03:20

Brazil's Regulatory Reset: A Guide to RDC 751/2022

Medical Device Global Market Access ·

2025/08/20

This episode unpacks Brazil's landmark medical device regulation, RDC 751/2022. We explore the key updates that align Brazil with global standards, including the new risk classification rules, the shift to an IMDRF-based Technical Dossier, and critical transition deadlines for manufacturers. Key Questions: • What major changes does RDC 751/2022 introduce for MedTech companies? • How do the new risk classification rules compare to the EU MDR? • What is the "Table of Contents" format, and how does it

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03:45

Navigating Europe's MedTech Shift: A Guide to EU MDR...

Medical Device Global Market Access ·

2025/08/19

This episode provides a dense overview of the EU Medical Device Regulation (MDR 2017/745), a pivotal shift in European MedTech compliance. We explore the regulation's core pillars, from its emphasis on a total product lifecycle approach and stricter clinical data requirements to the challenges of device reclassification, the Notified Body bottleneck, and new transparency measures like EUDAMED and the UDI system. It’s a crucial guide for any manufacturer navigating this complex landscape.• What is

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329 results

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