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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

03:19

EU IVDR: Navigating New Deadlines and Stricter Rules

Medical Device Global Market Access ·

2025/08/18

The European Union's In Vitro Diagnostic Regulation (IVDR) has replaced the IVDD, introducing a stricter, risk-based classification system and increasing Notified Body oversight for most devices. This episode breaks down the fundamental changes, the expanded scope that now includes software and genetic tests, and the critical extended transition deadlines established in July 2024, providing manufacturers with a clear roadmap for compliance. • What is the EU IVDR and how does it differ from the

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03:09

Navigating Canada's MedTech Market: A Guide to the CMDR

Medical Device Global Market Access ·

2025/08/17

Canada's medical device market is a significant opportunity, but navigating its regulatory framework, the CMDR (SOR/98-282), is essential for market entry. This episode provides a comprehensive overview of the Canadian Medical Devices Regulations, from its risk-based classification system to licensing, quality management, and post-market surveillance obligations for manufacturers and importers.• What are the four risk classes for medical devices in Canada? • What is the difference between a

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03:19

EU Clinical Trial Blueprint: Unpacking the MDCG...

Medical Device Global Market Access ·

2025/08/16

This episode dissects the critical MDCG 2024-3 guidance issued in March 2024, which outlines the European Union's expectations for a Clinical Investigation Plan (CIP). We explore how this document harmonizes the EU MDR and ISO 14155:2020, establishing the best-practice blueprint for planning medical device studies. We break down the essential components your CIP must include, from the benefit-risk analysis and statistical design to data management and safety reporting, to ensure a successful

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02:55

Navigating the UKCA Transition: Key Deadlines for...

Medical Device Global Market Access ·

2025/08/15

This episode breaks down the essential requirements of the UK MDR 2002, outlining the critical transition deadlines for moving from CE marking to the new UKCA mark. We cover the specific dates manufacturers need to know for 2028 and 2030, the mandatory role of the UK Responsible Person (UKRP), and the conformity assessment process with UK Approved Bodies. Learn the key steps to ensure your medical devices remain compliant for access to the Great Britain market. Key Questions: • What is the UKCA

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03:31

Unlocking U.S. Clinical Studies: A Deep Dive into 21...

Medical Device Global Market Access ·

2025/08/14

This episode demystifies the U.S. FDA's 21 CFR Part 812 regulation for Investigational Device Exemptions (IDEs). We explore the purpose of an IDE, the critical differences between significant and non-significant risk device studies, and the corresponding regulatory requirements for sponsors, investigators, and IRBs to ensure compliance during clinical trials.Key Questions: • What is an Investigational Device Exemption (IDE) and when is it required? • How does the FDA classify devices as

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03:23

Digital Compliance and Data Integrity: Mastering 21...

Medical Device Global Market Access ·

2025/08/13

This episode provides a comprehensive overview of the U.S. FDA's 21 CFR Part 11, detailing the essential compliance requirements for medical device companies using electronic records and signatures. We explore the core tenets of system validation, data integrity through audit trails, and the standards for legally binding electronic signatures, providing a clear roadmap for navigating this critical regulation.Key Questions: • What is 21 CFR Part 11 and when does it apply to a medical device

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03:50

FDA's New QMSR: Aligning with ISO 13485 and What It...

Medical Device Global Market Access ·

2025/08/12

This episode dives into the FDA's monumental shift from the Quality System Regulation (21 CFR Part 820) to the new Quality Management System Regulation (QMSR). We break down the incorporation of ISO 13485:2016, the critical effective date of February 2, 2026, and the specific additions and changes manufacturers must be aware of. We cover the new terminology, the integration of other FDA regulations, and the significant impact on inspections and risk management.Key Questions: • What is the new

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03:56

Decoding 21 CFR Part 814: A Guide to the FDA's...

Medical Device Global Market Access ·

2025/08/11

This episode provides a detailed overview of the FDA's Premarket Approval (PMA) process, governed by 21 CFR Part 814. We explore the requirements for Class III medical devices, the necessary components of a PMA submission, including non-clinical and clinical data, the FDA's review timeline and procedures, and the post-approval responsibilities of manufacturers. • What is a Premarket Approval (PMA) and which devices require it? • How does the FDA define a Class III medical device? • What are the

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03:16

FDA's New Cyber Mandate: Navigating the 2023 Medical...

Medical Device Global Market Access ·

2025/08/10

This episode breaks down the FDA's transformative final guidance on medical device cybersecurity issued in September 2023. We explore the new legal authorities granted by the Food and Drug Omnibus Reform Act (FDORA), the definition of a "cyber device," and the critical requirements for premarket submissions, including the Secure Product Development Framework (SPDF) and the mandatory Software Bill of Materials (SBOM). Learn what your company must do to avoid a "Refuse to Accept" (RTA) notice and

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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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