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 regimes, showing exactly how long each milestone really takes and where companies get stuck. • First-hand war stories – Hear candid interviews with regulatory veterans who have shepherded implants, software, wearables, diagnostics, and AI algorithms to market—and lived to tell the tale. • Real-time intelligence – Every episode covering the week’s new guidances, standards, and enforcement trends so you’re always ahead of the curve. • Actionable templates – From clinical evaluation checklists to technical-file skeletons, we break down the documents you’ll need and the pitfalls reviewers love to flag. • AI-powered insights – Because Pure Global mines millions of public filings, tenders, and recalls, we surface data-backed best practices you won’t hear at conferences—or from competitors. What you’ll hear • Launching SaMD under multiple risk classes in parallel • Surviving an unannounced ISO 13485 audit • Building a “reg-first” QMS that scales • Mastering Latin-American registrations without endless language cycles • Leveraging real-world evidence to shorten clinical timelines • Aligning cybersecurity, privacy, and post-market surveillance rules across regions Whether you’re plotting first entry, managing lifecycle expansions, or rescuing a delayed submission, subscribing could shave months—and millions—off your path to revenue. ⸻ Brought to you by Pure Global – the AI-native consultancy that already guides MedTech innovators through regulatory and market-access hurdles in 30 + countries. Ready for expert help on your next submission? Visit https://pureglobal.com or email info@pureglobal.com to start accelerating today.
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Medical Device Global Market Access is a technology podcast hosted by Unknown Host, with 0 episodes on record and a Required Pod Score of 80. PitchCentric scores this show on Booking Probability, Listen Score, and live audience signals refreshed every 24 hours.
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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 plan for simultaneous FDA and CMS decisions, and the critical public comment deadline of October 10, 2026. We explore what this means for innovative device manufacturers and provide practical steps for navigating this new reimbursement landscape. Key Questions: - What is the new CMS RAPID Coverage Pathway and what problem does it solve? - How does the RAPID pathway propose to align FDA authorization with Medicare coverage decisions? - Which specific types of medical devices are eligible for this expedited reimbursement program? - What was announced in the CMS procedural notice on August 7, 2026? - What is the significance of the October 10, 2026 deadline for public comments? - How should manufacturers adjust their evidence generation strategy to meet both FDA and CMS requirements? - What are the key differences between the FDA's 'safe and effective' standard and CMS's 'reasonable and necessary' criteria? - What practical steps should regulatory and market access teams take to prepare for the RAPID pathway? Sources: - https://www.cms.gov/newsroom/fact-sheets/regulatory-alignment-predictable-immediate-device-coverage-pathway-cms-3487-nc-procedural-notice - https://www.aha.org/news/headline/2026-08-07-cms-releases-notice-pathway-expediting-access-certain-medical-devices-medicare - https://www.hklaw.com/en/insights/publications/2026/08/rapid-coverage-pathway-comments-due-october-10-2026 - https://www.acrinews.org/archives/2026/August/CMS-Proposes-RAPID-Pathway-for-Faster-Device-Coverage - https://www.managedhealthcareexecutive.com/view/cms-and-fda-propose-rapid-medicare-coverage-pathway-for-breakthrough-devices - https://www.worktraining.com/news/cms-proposes-rapid-pathway-for-accelerated-medicare-coverage-of-innovative-medical-devices/ - https://www.federalregister.gov/documents/2026/08/11/2026-17389/medicare-program-regulatory-alignment-for-predictable-and-immediate-device-rapid-coverage-pathway How Pure Global can help: Navigating complex reimbursement pathways like the CMS RAPID program requires a strategic approach to both regulatory approval and market access. Pure Global provides end-to-end consulting for MedTech companies, developing efficient regulatory strategies that align with reimbursement requirements from the earliest stages. Our experts help you prepare for parallel engagement with bodies like the FDA and CMS, ensuring your technical dossier and clinical evidence meet the standards of multiple authorities. By leveraging our global network and advanced AI tools, we streamline dossier preparation and submission, helping you access markets faster. Contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI tools and regulatory database at https://pureglobal.ai.
Australia TGA Suspends Corpuls Defibrillators: What It Means for Post-Market Compliance
Aug 17, 20265 min
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 their ongoing compliance in the Australian market. Key Questions: - What did Australia's TGA announce on August 12, 2026, regarding Corpuls defibrillators? - What is the critical difference between a supply suspension and a medical device recall? - Why did the TGA take this precautionary action against the Corpuls 3 and 3T devices? - Can healthcare providers continue to use existing Corpuls defibrillators in Australia? - What does this TGA action signal about its approach to post-market surveillance and enforcement? - How should other medical device manufacturers respond to this development? - What specific steps can regulatory and quality teams take to ensure their own compliance? - How does this event impact Australian sponsors and their responsibilities? Sources: - https://www.tga.gov.au/news/media-releases/safety-medical-devices - https://www.tga.gov.au/resources/news-articles-and-updates/medical-devices How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies seeking to access markets like Australia. Our services include developing robust regulatory strategies, acting as your local Australian sponsor, managing technical dossier submissions, and ensuring ongoing post-market compliance. We combine local expertise with advanced AI to streamline global market access and help you navigate complex regulatory challenges, like TGA enforcement actions. For support, contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI regulatory tools and device database at https://pureglobal.ai.
MHRA National Alert DSI/2026/007: Quarantining Devices Without UKCA or CE Marks
Aug 16, 20266 min
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 the MHRA's national alert DSI/2026/007? - Which types of medical devices are affected by this quarantine order? - Why is a missing UKCA or CE mark a critical patient safety concern? - What are the immediate legal and regulatory duties for UK healthcare organizations? - How should distributors respond to the MHRA's directive? - What practical steps can procurement teams take to verify device conformity upon receipt? - How can this incident inform supplier qualification and management processes? - What are the long-term implications for supply chain integrity in the UK MedTech market? Sources: - https://www.gov.uk/government/news/mhra-advises-quarantine-of-medical-devices-supplied-without-appropriate-conformity-markings How Pure Global can help: Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We act as a local representative and help with regulatory strategy, technical dossier submission, and post-market surveillance. Our AI and data tools streamline market research and compliance, helping you access over 30 global markets efficiently. Whether you're a startup or a multinational enterprise, our global reach and local expertise ensure your products meet all necessary standards for faster market access. For help navigating requirements like UKCA marking and supply chain compliance, visit us at https://pureglobal.com, contact us at info@pureglobal.com, or explore our free AI tools and device database at https://pureglobal.ai.
MHRA Non-Compliant Medical Devices: UK Quarantine Order and Supply Chain Lessons
Aug 15, 20265 min
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 consequences for manufacturers and distributors and provide practical steps for regulatory and quality teams to ensure supply chain integrity. Key Questions: - What did the UK MHRA's DSI/2026/007 alert require healthcare providers to do? - Which types of medical devices were ordered into quarantine on August 10, 2026? - Why did the MHRA take decisive action without any reported adverse events? - What does this incident reveal about supply chain integrity in the UK medical device market? - How can distributors and importers strengthen their supplier verification processes? - What are the severe market access consequences of failing to have proper conformity markings? - How can manufacturers protect their brand from non-compliant distribution partners? - What practical steps should regulatory and quality teams take in response to this case study? Sources: - https://www.gov.uk/government/news/mhra-advises-quarantine-of-medical-devices-supplied-without-appropriate-conformity-markings - https://www.gov.uk/drug-device-alerts/devices-supplied-without-valid-ukca-slash-ce-conformity-markings-or-certification-remove-from-use-and-place-in-quarantine-dsi-slash-2026-slash-007 - https://pharmacy.biz/mhra-alert-on-medical-devices-that-lack-quality-approval/ - https://www.medregconsulting.com/post/mhra-orders-halt-to-supply-and-use-of-non-compliant-medical-devices How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex global markets like the UK. Our experts develop efficient regulatory strategies, manage technical dossier submissions, and act as your local representative to ensure full compliance with authorities like the MHRA. We help you verify supply chain partners and maintain continuous regulatory monitoring to prevent costly non-compliance issues. By combining local expertise with advanced AI, we streamline market access and protect your brand's integrity. Contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI tools and device database at https://pureglobal.ai.
FDA MDUFA VI Fees: Proposed Increases for Overseas Manufacturers
Aug 14, 20265 min
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 important for medical device manufacturers? - What specific fee changes are being proposed for overseas facilities? - What was the FDA's rationale for the proposed fee increase? - What are the key dates and deadlines for providing public feedback? - How could these changes impact your company's budget and market access strategy for the US? - What steps should your regulatory team take now to prepare? - Why are foreign establishment inspection costs a central part of this discussion? - When is the final MDUFA VI package expected to be sent to Congress? Sources: - https://www.medtechdive.com/news/mdufa-vi-fda-industry-patient-device-fees/723118/ How Pure Global can help: Pure Global helps MedTech and IVD companies navigate complex regulatory changes like the FDA's MDUFA VI proposal. We provide strategic guidance on US market access, help you analyze the financial impact of new fee structures, and assist in preparing technical dossiers and submissions. Our combination of local US regulatory expertise and advanced AI technology streamlines the path to market, ensuring you can adapt to new requirements efficiently. Whether you're a startup or a global enterprise, we can help you maintain and expand your presence in the US market. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.
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