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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

Post-Brexit MedTech: Your Guide from FDA to UKCA Marking

Medical Device Global Market Access ·

2025/08/09

This episode breaks down the essential steps for medical device manufacturers with FDA clearance to successfully enter the post-Brexit UK market. We clarify why FDA approval isn't recognized by the MHRA and detail the two main pathways to achieving UKCA certification: leveraging the CE mark transition period and direct conformity assessment. Learn about critical deadlines, the role of the UK Responsible Person, and how to stay compliant. Key Questions: • Does my FDA 510(k) clearance fast-track UK

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03:14

One Audit, Five Markets: Navigating the Medical...

Medical Device Global Market Access ·

2025/08/08

This episode demystifies the Medical Device Single Audit Program (MDSAP), a unified approach that allows MedTech manufacturers to satisfy the quality management system requirements of five major markets—Australia, Brazil, Canada, Japan, and the U.S.—through a single audit. Learn about its history, the audit cycle, and the specific benefits for accessing each market, including its mandatory status in Canada.• What exactly is the Medical Device Single Audit Program (MDSAP)? • Which five major global

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03:23

Beyond FDA Approval: Unlocking the Saudi Arabian...

Medical Device Global Market Access ·

2025/08/07

Securing FDA approval is a major milestone, but it's only the first step for entering the Saudi Arabian market. This episode breaks down the essential, non-negotiable requirements of the Saudi Food and Drug Authority (SFDA) for medical device listing. We detail the mandatory Technical File Assessment (TFA) route, the crucial role of the in-country Authorized Representative, and the specific documentation that goes beyond your FDA submission.Key Questions: • Is my US FDA approval enough to sell my

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03:28

Beyond FDA Clearance: Unlocking Japan's PMDA Approval

Medical Device Global Market Access ·

2025/08/06

This episode demystifies the process of obtaining medical device approval in Japan for companies that already have FDA clearance. We explore the critical differences between the two systems and outline the essential steps manufacturers must take, from appointing a local representative to preparing a Japan-specific submission dossier and navigating clinical data requirements for either Shonin or Ninsho approval.Key Questions: • Does FDA clearance guarantee market access in Japan? • What is a

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03:11

Beyond FDA: Securing Your Medical Device Import...

Medical Device Global Market Access ·

2025/08/05

This episode demystifies the process for medical device manufacturers who have U.S. FDA approval and are targeting the Indian market. We clarify that while FDA registration is beneficial, it does not replace the mandatory import license from India's Central Drugs Standard Control Organization (CDSCO). We outline the essential steps, including appointing an Authorized Indian Agent, understanding India's risk-based device classification, and preparing the required Device and Plant Master Files for a

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03:25

Cracking the Code: South Korea's MFDS for...

Medical Device Global Market Access ·

2025/08/04

This episode explores the process for medical device manufacturers to enter the South Korean market after receiving FDA approval. We delve into the specifics of the Ministry of Food and Drug Safety (MFDS) requirements, comparing its risk-based classification and submission pathways to the U.S. system. The discussion focuses on the practical steps for leveraging existing FDA testing data, the critical need for Korea Good Manufacturing Practice (KGMP) certification, and the role of a local Korea

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03:21

The Human Factor: A Practical Guide to IEC 62366-1...

Medical Device Global Market Access ·

2025/08/03

This episode demystifies the globally recognized standard IEC 62366-1:2015, which governs the application of usability engineering to medical devices. We explore how this process-oriented standard is critical not just for user satisfaction, but for ensuring patient safety by minimizing use-related risks. Learn about the key phases, from defining use specifications and conducting formative evaluations to performing final summative validation, all of which are essential for securing market access in

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03:09

Unlocking Global Markets with the New Health Software...

Medical Device Global Market Access ·

2025/08/02

This episode delves into the critical cybersecurity standard IEC 81001-5-1, published in 2021. We explore its origins, its comprehensive lifecycle approach to securing health software, and its growing importance for regulatory approval in key global markets like the EU, US, and Japan. Manufacturers will learn what the standard requires and why compliance is no longer optional but a strategic advantage. Key Questions: • What is IEC 81001-5-1 and why was it created? • How does this standard change

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02:50

One Audit, Five Markets: Unlocking Global Access with...

Medical Device Global Market Access ·

2025/08/01

This episode demystifies the Medical Device Single Audit Program (MDSAP), a framework allowing a single audit to satisfy the regulatory requirements of five different countries. We explore its history, the participating authorities, the benefits for manufacturers—including reduced audit fatigue and faster market access—and how the program streamlines global compliance.• What is the Medical Device Single Audit Program (MDSAP)? • Which five major global markets can you access with a single audit? •

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03:26

From FDA Clearance to TGA Inclusion: Navigating the...

Medical Device Global Market Access ·

2025/07/31

This episode details the specific steps and documentation required to list an FDA-cleared medical device on Australia's Australian Register of Therapeutic Goods (ARTG). We explore how leveraging your existing FDA approval can streamline the TGA inclusion process, the critical role of an Australian Sponsor, and the importance of recent regulatory updates effective in late 2024.• Is my FDA clearance automatically accepted in Australia? • What is the very first step for a foreign manufacturer to

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03:43

From FDA PMA to Health Canada: A Guide to Licensing...

Medical Device Global Market Access ·

2025/07/30

Holding FDA PMA approval is a significant achievement, but what does it mean for entering the Canadian market? This episode breaks down the essential steps and requirements for obtaining a Health Canada Medical Device Licence for your high-risk device. We explore how to leverage your existing FDA data while navigating Canada's unique regulatory landscape.• Does FDA PMA guarantee a Health Canada licence? • What are the Canadian device classifications for high-risk products? • Is an FDA-compliant

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03:49

From FDA 510(k) to EU CE Mark: Bridging the...

Medical Device Global Market Access ·

2025/07/29

Think your FDA 510(k) is a fast track to a European CE Mark? This episode uncovers the critical gaps between the two regulatory systems. We explore the fundamental differences in philosophy, from the FDA's "substantial equivalence" model to the EU MDR's lifecycle approach, and detail the extra work required in quality management, clinical evidence, technical documentation, and post-market surveillance to achieve compliance in Europe. Key Questions: • Is a 510(k) clearance a shortcut to getting an

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03:31

Leveraging Your FDA De Novo for Brazilian Market Access

Medical Device Global Market Access ·

2025/07/28

This episode breaks down how to leverage an FDA De Novo grant to achieve medical device registration in Brazil with ANVISA. We explain that while the De Novo is a powerful asset, it does not grant automatic approval. We cover the essential steps, from determining your device's risk classification under Brazilian regulations to understanding the different registration pathways (*Notificação* vs. *Registro*), the mandatory requirement of a Brazil Registration Holder (BRH), and the importance of

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03:18

Beyond FDA Clearance: A Guide to China's NMPA Medical...

Medical Device Global Market Access ·

2025/07/27

This episode demystifies the process for registering an FDA-cleared medical device in China. We explore why FDA approval is only the first step and detail the unique requirements of the National Medical Products Administration (NMPA), including classification, local agent representation, in-country testing, and clinical data validation for the Chinese market. Key Questions: • Is my US FDA clearance sufficient for selling my device in China? • What is an NMPA Legal Agent and why do I need one? •

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03:47

Beyond the Lab: Mastering Clinical Trials with ISO...

Medical Device Global Market Access ·

2025/07/26

This episode provides a detailed overview of ISO 14155:2020, the international standard for Good Clinical Practice in medical device investigations. We explore the key updates from the previous version, focusing on the integration of risk management, new planning requirements, and operational changes that impact how manufacturers design and conduct clinical trials. Learn what your team needs to know to ensure compliance and generate robust clinical data for global regulatory submissions.Key

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03:27

Navigating the New Rules of Medical Device Risk: ISO...

Medical Device Global Market Access ·

2025/07/25

This episode demystifies the latest version of the essential risk management standard, ISO 14971:2019. We explore the critical updates manufacturers must understand, from the expanded scope covering the entire device lifecycle to the proactive requirements for post-market activities. Learn about the key definition changes and the enhanced focus on benefit-risk analysis that are shaping global regulatory compliance and patient safety. Key Questions: • What prompted the update from the 2007 version

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03:25

From EC REP to EU REP: Decoding Critical Medical...

Medical Device Global Market Access ·

2025/07/24

This episode breaks down the essential updates from ISO 15223-1:2021 and its recent 2025 amendment. We explore the new symbols for medical devices, translations, and sterilization, and detail the critical shift from the 'EC REP' to the 'EU REP' symbol, explaining the reasons and the compliance timeline for manufacturers.Key Questions: • What is ISO 15223-1:2021 and why is it essential for medical device labeling? • Which new symbols were introduced in the latest version? • Why is the 'EC REP'

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03:45

Unpacking IEC 60601-1 Edition 3.2: The New Standard...

Medical Device Global Market Access ·

2025/07/23

This episode breaks down the critical updates in IEC 60601-1 Edition 3.2, the mandatory electrical safety standard for medical devices. We cover the key changes from Amendment 2, including alignment with ISO 14971, the adoption of IEC 62368-1 for IT equipment, and refined requirements for Means of Protection (MOP), helping manufacturers understand the impact on new device submissions, particularly since the FDA's enforcement date of December 17, 2023.• What is the primary goal of IEC 60601-1 and

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03:36

The Golden Key: How ISO 13485 Unlocks Global MedTech...

Medical Device Global Market Access ·

2025/07/22

This episode demystifies ISO 13485:2016, the internationally recognized standard for Quality Management Systems (QMS) in the medical device industry. We explore the standard's core requirements, the critical changes introduced in the 2016 revision, and why compliance is the essential key for any MedTech company aiming to achieve regulatory approval and unlock access to markets across the globe, from the EU to the United States. Key Questions • What is ISO 13485 and how does it differ from the more

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03:12

Intuitive's Newest Robot: A Surgeon's Sense of Touch

Medical Device Global Market Access ·

2025/07/21

This episode unpacks the landmark FDA clearance of Intuitive Surgical's da Vinci 5, the next generation in soft-tissue robotics. We explore its groundbreaking features, including Force Feedback technology that gives surgeons a sense of touch, a 10,000-fold increase in computing power, and enhanced 3D visualization. We also analyze its strategic importance in a competitive market and what it means for the future of surgery. Key Questions: • What is the most significant upgrade in Intuitive's da

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260 results

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