Shows / Medical Device Global Market Access
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…
Episodes
- Medical Device Global Market Access
Your Product's Passport: Unlocking Global Sales with an FSC
In this episode, we demystify the Free Sales Certificate (FSC), a critical document for medical device and IVD manufacturers aiming for international…
- Medical Device Global Market Access
Certificate of Free Sale: Who Is Eligible to Apply?
This episode clarifies the complex eligibility requirements for obtaining a Certificate of Free Sale (FSC) for medical device exports. We dissect the critical…
- Medical Device Global Market Access
Navigating FDA Export Certificates: Timelines, Fees, and 2024 Updates
This episode demystifies the process of obtaining a Certificate to Foreign Government (CFG), also known as a Free Sale Certificate (FSC), from the US FDA. We…
- Medical Device Global Market Access
Unlocking the FDA 510(k) with Your Japanese PMDA Approval
Many companies believe that getting medical device approval in Japan might fast-track their entry into the U.S. market. This episode breaks down that…
- Medical Device Global Market Access
From China to Brazil: Navigating ANVISA without NMPA Reliance
This episode clarifies whether a medical device approved by China's NMPA can benefit from an expedited registration process with Brazil's ANVISA. We detail the…
- Medical Device Global Market Access
From Brazil to the US: Unpacking ANVISA and FDA 510(k) Pathways
This episode tackles a common question from MedTech manufacturers: can a successful ANVISA registration in Brazil streamline the path to FDA 510(k) clearance…
- Medical Device Global Market Access
From NMPA to CE Mark: Bridging the Regulatory Gap
This episode breaks down the essential differences between China's NMPA approval and the EU's rigorous MDR CE marking process. We explore the key gaps in…
- Medical Device Global Market Access
From NMPA to FDA: Leveraging China Approval for U.S. Market Entry
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…
- Medical Device Global Market Access
From Tokyo to Brussels: Navigating the EU MDR After Japan Shonin
Securing Shonin approval in Japan is a huge regulatory achievement, but it doesn’t guarantee a simple path to the European market. This episode breaks down the…
- Medical Device Global Market Access
From Europe to Down Under: A Guide to TGA Approval with Your CE Mark
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…
- Medical Device Global Market Access
De Novo Submissions: Will Your CE Mark Data Pass FDA Scrutiny?
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…
- Medical Device Global Market Access
CE Mark to FDA 510(k): A Guide for MedTech Manufacturers
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…
- Medical Device Global Market Access
From Europe to Japan: Leveraging Your CE Mark for PMDA Approval
Navigating Japan's rigorous PMDA approval process can be challenging, even for devices that already have a CE mark. This episode demystifies the requirements…
- Medical Device Global Market Access
From Europe to Brazil: Bridging the CE Mark and ANVISA Gap
This episode demystifies the process of bringing a CE-marked medical device to the Brazilian market. We break down the critical differences between European…
- Medical Device Global Market Access
From MDR to NMPA: A Strategic Guide to China Market Entry
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…
- Medical Device Global Market Access
From CE to UKCA: Navigating the UK Medical Device Transition
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…
- Medical Device Global Market Access
Unlocking the Canadian MedTech Market: Beyond the CE Mark
This episode demystifies the process for CE-marked device manufacturers to obtain a Health Canada Medical Device Establishment Licence (MDEL) for selling in…
- Medical Device Global Market Access
Cracking the Code: Japan's PMD Act & QMS Requirements
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…
- Medical Device Global Market Access
China's Regulatory Overhaul: Your Guide to NMPA Order 739
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…
- Medical Device Global Market Access
Unlocking the Indian Market: A Guide to the 2017 and 2023 Device Rules
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…
- Medical Device Global Market Access
China's New Electrical Safety Standard: Navigating the GB 9706.1-2020 Transition
China's new electrical safety standard, GB 9706.1-2020, is now in effect, creating critical deadlines and new requirements for medical device manufacturers…
- Medical Device Global Market Access
South Korea's Game-Changing 2025 Digital Medical Products Act
This episode unpacks South Korea's pioneering Digital Medical Products Act (DMPA), set to revolutionize the regulatory landscape in January 2025. We explore…
- Medical Device Global Market Access
TGA Approval Down Under: A Guide to the 2002 Medical Device Regulations
This episode provides a comprehensive overview of Australia's medical device regulations, governed by the Therapeutic Goods Administration (TGA). We explore…
- Medical Device Global Market Access
Decoding NOM-241: Mexico's New GMP Framework for Medical Devices
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…
- Medical Device Global Market Access
Argentina's MedTech Gateway: Unpacking ANMAT's Key Registration Rules
This episode demystifies Argentina's medical device registration process under the national regulatory body, ANMAT. We provide a detailed breakdown of the…
- Medical Device Global Market Access
Brazil's Regulatory Reset: A Guide to RDC 751/2022
This episode unpacks Brazil's landmark medical device regulation, RDC 751/2022. We explore the key updates that align Brazil with global standards, including…
- Medical Device Global Market Access
Colombian Market Entry: Your Guide to Decree 4725 and INVIMA
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…
- Medical Device Global Market Access
Navigating Europe's MedTech Shift: A Guide to EU MDR Compliance
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…
- Medical Device Global Market Access
EU IVDR: Navigating New Deadlines and Stricter Rules
The European Union's In Vitro Diagnostic Regulation (IVDR) has replaced the IVDD, introducing a stricter, risk-based classification system and increasing…
- Medical Device Global Market Access
Navigating Canada's MedTech Market: A Guide to the CMDR
Canada's medical device market is a significant opportunity, but navigating its regulatory framework, the CMDR (SOR/98-282), is essential for market entry…
- Medical Device Global Market Access
EU Clinical Trial Blueprint: Unpacking the MDCG 2024-3 Guidance
This episode dissects the critical MDCG 2024-3 guidance issued in March 2024, which outlines the European Union's expectations for a Clinical Investigation…
- Medical Device Global Market Access
Navigating the UKCA Transition: Key Deadlines for Medical Device Manufacturers
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…
- Medical Device Global Market Access
Unlocking U.S. Clinical Studies: A Deep Dive into 21 CFR Part 812
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…
- Medical Device Global Market Access
Digital Compliance and Data Integrity: Mastering 21 CFR Part 11
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…
- Medical Device Global Market Access
FDA's New QMSR: Aligning with ISO 13485 and What It Means For You
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)…
- Medical Device Global Market Access
Decoding 21 CFR Part 814: A Guide to the FDA's Premarket Approval Pathway
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 Device Global Market Access
FDA's New Cyber Mandate: Navigating the 2023 Medical Device Security Rules
This episode breaks down the FDA's transformative final guidance on medical device cybersecurity issued in September 2023. We explore the new legal authorities…
- Medical Device Global Market Access
Post-Brexit MedTech: Your Guide from FDA to UKCA Marking
This episode breaks down the essential steps for medical device manufacturers with FDA clearance to successfully enter the post-Brexit UK market. We clarify…
- Medical Device Global Market Access
One Audit, Five Markets: Navigating the Medical Device Single Audit Program
This episode demystifies the Medical Device Single Audit Program (MDSAP), a unified approach that allows MedTech manufacturers to satisfy the quality…
- Medical Device Global Market Access
Beyond FDA Approval: Unlocking the Saudi Arabian MedTech Market
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…
- Medical Device Global Market Access
Beyond FDA Clearance: Unlocking Japan's PMDA Approval
This episode demystifies the process of obtaining medical device approval in Japan for companies that already have FDA clearance. We explore the critical…
- Medical Device Global Market Access
Beyond FDA: Securing Your Medical Device Import License in India
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…
- Medical Device Global Market Access
Cracking the Code: South Korea's MFDS for FDA-Approved Devices
This episode explores the process for medical device manufacturers to enter the South Korean market after receiving FDA approval. We delve into the specifics…
- Medical Device Global Market Access
The Human Factor: A Practical Guide to IEC 62366-1 Usability Engineering
This episode demystifies the globally recognized standard IEC 62366-1:2015, which governs the application of usability engineering to medical devices. We…
- Medical Device Global Market Access
Unlocking Global Markets with the New Health Software Security Standard
This episode delves into the critical cybersecurity standard IEC 81001-5-1, published in 2021. We explore its origins, its comprehensive lifecycle approach to…
- Medical Device Global Market Access
One Audit, Five Markets: Unlocking Global Access with MDSAP
This episode demystifies the Medical Device Single Audit Program (MDSAP), a framework allowing a single audit to satisfy the regulatory requirements of five…
- Medical Device Global Market Access
From FDA Clearance to TGA Inclusion: Navigating the Australian Medical Device Market
This episode details the specific steps and documentation required to list an FDA-cleared medical device on Australia's Australian Register of Therapeutic…
- Medical Device Global Market Access
From FDA PMA to Health Canada: A Guide to Licensing High-Risk Medical Devices
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…
- Medical Device Global Market Access
From FDA 510(k) to EU CE Mark: Bridging the Regulatory Gap
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…
- Medical Device Global Market Access
Leveraging Your FDA De Novo for Brazilian Market Access
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…
- Medical Device Global Market Access
Beyond FDA Clearance: A Guide to China's NMPA Medical Device Registration
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…
- Medical Device Global Market Access
Beyond the Lab: Mastering Clinical Trials with ISO 14155:2020
This episode provides a detailed overview of ISO 14155:2020, the international standard for Good Clinical Practice in medical device investigations. We explore…
- Medical Device Global Market Access
Navigating the New Rules of Medical Device Risk: ISO 14971:2019 Explained
This episode demystifies the latest version of the essential risk management standard, ISO 14971:2019. We explore the critical updates manufacturers must…
- Medical Device Global Market Access
From EC REP to EU REP: Decoding Critical Medical Device Symbol Changes
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…
- Medical Device Global Market Access
Unpacking IEC 60601-1 Edition 3.2: The New Standard for Electrical Safety
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…
- Medical Device Global Market Access
The Golden Key: How ISO 13485 Unlocks Global MedTech Markets
This episode demystifies ISO 13485:2016, the internationally recognized standard for Quality Management Systems (QMS) in the medical device industry. We…
- Medical Device Global Market Access
Intuitive's Newest Robot: A Surgeon's Sense of Touch
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…
- Medical Device Global Market Access
From Lab to Life: The Rise of Bioactive 3D-Printed Spinal Implants
This episode delves into the revolutionary world of personalized 3D-printed spinal implants, highlighting Xenco Medical's TrabeculeX Continuum. We explore how…
- Medical Device Global Market Access
From Niche to Mainstream: The AI Revolution in Wearable Health Tech
This episode explores the rapid expansion of AI-integrated wearables, focusing on how continuous glucose monitors (CGMs) are transitioning from clinical…
- Medical Device Global Market Access
The Remote Revolution: How At-Home Devices Are Solving the Physical Therapy Crisis
This episode explores the rise of remote physical therapy devices like ROMTech's PortableConnect as a direct response to the significant shortage of physical…