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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

04:21

India CDSCO Amends Sterilization Rules: What Removing...

Medical Device Global Market Access ·

2026/08/27

India's CDSCO has amended the Medical Devices Rules, 2017, effective August 24, 2024, removing the 'loan licence' requirement for manufacturers who outsource device sterilization. This episode explains the amendment, details the new mandatory labeling requirements for sterilized products, and outlines the practical steps that regulatory and quality teams must take during the six-month transition period to ensure compliance.Key Questions: - What was the 'loan licence' requirement for medical device

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04:41

EU Notified Body Shake-Up: What the NSAI and TÜV NORD...

Medical Device Global Market Access ·

2026/08/26

The EU Notified Body landscape was shaken in August 2024 with announcements that the National Standards Authority of Ireland (NSAI) will exit its MDR designation by 2026 and TÜV NORD Scandinavia has filed for bankruptcy. This episode breaks down the immediate impact on manufacturers certified by these bodies, the broader implications for Notified Body capacity under the MDR, and the critical strategic steps regulatory teams must take now to protect their EU market access.Key Questions: - What were

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05:03

Japan PMDA Workshop: A Guide to Medical Device Market...

Medical Device Global Market Access ·

2026/08/25

Japan's PMDA and AdvaMed are hosting a free online workshop on September 1, 2026, for U.S.-based small and mid-sized medtech companies. This episode breaks down the significance of this direct engagement opportunity, covering the key topics on the agenda—including Japan's regulatory framework, scientific advice process, and review pathways. We discuss the strategic value for manufacturers and provide practical steps your regulatory and market access teams should take to maximize the benefits of this

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04:45

UK MHRA Rectal Catheter Alert: Infant Safety and...

Medical Device Global Market Access ·

2026/08/24

This episode examines the UK MHRA's Device Safety Information alert (DSI/2026/008), issued on August 18, 2026, which advises against the use of rectal catheters (gas/colic relievers) in infants. We explore why the MHRA took this precautionary action based on a lack of safety and efficacy data, rather than direct adverse event reports. The discussion focuses on the critical post-market surveillance lessons for manufacturers of direct-to-consumer medical devices, particularly those intended for

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05:01

Brazil ANVISA Innovative Device Pilot Program 2026: A...

Medical Device Global Market Access ·

2026/08/23

Brazil's ANVISA has opened a new pathway for innovative, high-risk medical devices. On August 5, 2026, the agency published Call Notice 5/2026, inviting manufacturers of Class III and IV devices with novel technologies to apply for a collaborative regulatory evaluation pilot program. This episode details the program's objectives, strict eligibility criteria (including AI-based devices and new biomaterials), the critical 30-day application window, and the strategic advantages of early engagement with

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04:41

SFDA Biocompatibility Requirements: Preparing Medical...

Medical Device Global Market Access ·

2026/08/22

The Saudi Food and Drug Authority (SFDA) is increasing its focus on the biological evaluation of medical devices, highlighted by its upcoming workshop on August 10, 2026. This episode explores what this means for manufacturers seeking market access in Saudi Arabia. We discuss the SFDA's alignment with ISO 10993, the critical importance of a risk-based approach, and the need for a comprehensive Biological Evaluation Report (BER) in your technical dossier. Learn practical steps to review your existing

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05:16

FDA Discussion Paper on Generative AI in Medical...

Medical Device Global Market Access ·

2026/08/21

This episode details the US FDA's discussion paper on regulating medical devices incorporating Generative Artificial Intelligence (GenAI), released on August 18, 2026. We cover the key areas where the FDA is seeking input, including risk assessment, premarket evaluation, and postmarket monitoring for GenAI-enabled devices. We also emphasize the critical October 19, 2026, deadline for submitting feedback and provide practical steps for manufacturers to prepare and respond.Key Questions: - What is

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04:33

FDA Proposed Rule on Class I Accessories: 2026...

Medical Device Global Market Access ·

2026/08/20

This episode covers the U.S. FDA's proposed rule from August 14, 2026, which aims to classify a specific list of medical device accessories as Class I. We discuss how this change would exempt these products from 510(k) premarket notification, significantly reducing the regulatory burden for manufacturers. The host details the implications for market access strategy, the cost and time savings, and highlights the critical public comment deadline of October 16, 2026, urging listeners to review the list

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05:31

Saudi Arabia SFDA Medical Device Advertising Rules:...

Medical Device Global Market Access ·

2026/08/19

The Saudi Food and Drug Authority (SFDA) has implemented new mandatory requirements for medical device advertising, effective July 20, 2026. This episode breaks down the key provisions of the new guidance, MDS-REQ 8, which mandates pre-approval from the SFDA for all advertising, awareness, and charitable campaigns. We explore the broad scope of materials covered—from social media to brochures—the official submission process through the GHAD electronic system, and the critical responsibilities of

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05:26

CMS RAPID Coverage Pathway: Breakthrough Device...

Medical Device Global Market Access ·

2026/08/18

The U.S. Centers for Medicare & Medicaid Services (CMS) has introduced a major policy change with the new Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. Announced in a procedural notice on August 7, 2026, this pathway aims to significantly reduce the delay between FDA market authorization and a national Medicare coverage decision for eligible FDA Breakthrough-designated devices. This episode breaks down the eligibility criteria for Class II and III devices, the

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05:23

Australia TGA Suspends Corpuls Defibrillators: What...

Medical Device Global Market Access ·

2026/08/17

On August 12, 2026, Australia's Therapeutic Goods Administration (TGA) suspended the supply of Corpuls 3 and 3T defibrillators. This episode breaks down the TGA's precautionary action, clarifying the critical difference between a supply suspension and a device recall. We explore why the TGA acted, who is affected, and what this signals about the regulator's increasingly proactive approach to post-market surveillance. Learn the practical steps all medical device manufacturers should take to ensure

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06:08

MHRA National Alert DSI/2026/007: Quarantining...

Medical Device Global Market Access ·

2026/08/16

This episode examines the UK MHRA's national alert DSI/2026/007, issued on August 10, 2026, which mandates the quarantine of medical devices supplied without the necessary UKCA or CE conformity markings. We break down the patient safety risks posed by non-compliant devices, identify the specific actions required of healthcare providers and distributors, and outline critical lessons for supply chain management and procurement to prevent future incidents.Key Questions: - What is the significance of

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05:22

MHRA Non-Compliant Medical Devices: UK Quarantine...

Medical Device Global Market Access ·

2026/08/15

The UK's MHRA issued a Device Safety Information alert (DSI/2026/007) on August 10, 2026, ordering an immediate quarantine of six types of medical devices, including scalpels and blood collection sets, that were supplied without the required UKCA or CE conformity markings. This episode breaks down the MHRA's rationale, which focused on the lack of assured safety and quality due to the missing conformity assessment, even without any reported adverse events. We explore the significant market access

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04:47

FDA MDUFA VI Fees: Proposed Increases for Overseas...

Medical Device Global Market Access ·

2026/08/14

The US FDA is considering higher user fees for overseas medical device manufacturers under the proposed MDUFA VI agreement for fiscal years 2028-2032. This episode breaks down the key takeaways from the FDA's public meeting on August 10, 2026, including the agency's rationale for the increase, the potential financial impact on non-US firms, and the critical deadlines for submitting public feedback before the proposal goes to Congress in January 2027.Key Questions: - What is MDUFA VI and why is it

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04:50

India's Draft Drugs, Medical Devices and Cosmetics...

Medical Device Global Market Access ·

2026/08/13

This episode covers India's draft Drugs, Medical Devices and Cosmetics Bill 2026, circulated for feedback on August 7, 2026. We discuss its proposal to replace the 1940 Drugs and Cosmetics Act, creating a separate regulatory framework for medical devices, establishing a Medical Devices Technical Advisory Board (MDTAB), and enhancing enforcement powers. We explore the impact on manufacturers and provide practical steps for regulatory teams to prepare for this significant shift in India's MedTech

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05:19

Health Canada MDEL Modernization: Preparing for Phase...

Medical Device Global Market Access ·

2026/08/12

Health Canada is implementing Phase 2 of its Medical Device Establishment Licence (MDEL) modernization, with all changes coming into force on December 14, 2026. This episode provides a detailed breakdown of the key amendments published on June 17, 2026. We cover the removal of the MDEL requirement for certain foreign distributors, the new mandate for importers and distributors to provide a supplier list in their applications, and the more prescriptive requirements for documented procedures covering

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05:41

EU AI Act and Medical Devices: New Compliance...

Medical Device Global Market Access ·

2026/08/11

This episode covers the EU's postponement of the AI Act compliance deadline for high-risk AI medical devices to August 2, 2028. We discuss Regulation (EU) 2026/1744, explaining what this extension means for manufacturers navigating dual compliance under the MDR/IVDR and the AI Act. We offer practical steps for regulatory, quality, and market-access teams to effectively use this extra time to integrate compliance, engage with Notified Bodies, and strengthen their technical documentation.Key

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04:29

China NMPA's 57 New Medical Device Guidelines:...

Medical Device Global Market Access ·

2026/08/10

On July 21, 2026, China's NMPA released 57 new medical device guidelines, creating immediate compliance challenges for manufacturers. This episode breaks down the immediate impact of these guidelines, covering the new requirements for technical documentation, clinical data, and product testing. We discuss who is affected and outline practical steps for regulatory and quality teams to perform gap assessments and update their submission dossiers for both new and renewing products. Key Questions: -

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05:02

FDA Human Factors Guidance 2026: Navigating New eSTAR...

Medical Device Global Market Access ·

2026/08/09

The US FDA has finalized its guidance on 'Content of Human Factors Information in Medical Device Marketing Submissions,' introducing a new risk-based framework that became mandatory within the eSTAR portal on August 1, 2026. This episode details the three new risk categories for Human Factors Engineering (HFE) and Usability Engineering (UE) data, explains how they impact 510(k), PMA, and De Novo submissions, and provides practical steps for manufacturers to adapt their processes and documentation to

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04:50

ANVISA Chile ISP Cooperation: Preparing for Latin...

Medical Device Global Market Access ·

2026/08/08

This episode explores the technical exchange held between Brazil's ANVISA and Chile's ISP from July 6-10, 2026. We analyze the key topics discussed—including Brazilian Good Manufacturing Practices (BGMP), import controls, and post-market surveillance—and explain how this collaboration signals a significant move toward regulatory convergence in Latin America. We outline the practical implications for medical device manufacturers and provide concrete steps for regulatory teams to prepare for a more

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454 results

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