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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

03:25

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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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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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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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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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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260 results

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