『Medical Device Global Market Access』のカバーアート

Medical Device Global Market Access

Medical Device Global Market Access

著者： Pure Global
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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.Copyright 2026 Pure Global
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  • Brazil ANVISA's New Notification Guidance: What Class I/II Medical Device and IVD Manufacturers Need to Know

    Brazil ANVISA's New Notification Guidance: What Class I/II Medical Device and IVD Manufacturers Need to Know
    2026/09/07
    Brazil's ANVISA has published two new guidance manuals detailing the 'notification' pathway for Class I and II medical devices and IVDs. This episode explains how these manuals, released on August 25, 2023, clarify the submission processes under RDC 751/2022 and RDC 830/2023, what practical information they contain for manufacturers, and the concrete steps regulatory teams should take to streamline market access for lower-risk products in Brazil. Key Questions: - What are the new ANVISA guidance manuals for the notification pathway? - Which medical device and IVD classes are affected by this new guidance? - How does this guidance clarify the submission process under RDC 751/2022 and RDC 830/2023? - What specific documentation is required for a notification submission in Brazil? - How should manufacturers use ANVISA's electronic portal for notifications? - What are the rules for grouping multiple devices in a single submission? - What are the post-market responsibilities for notified devices in Brazil? - What practical steps should my regulatory team take in response to this new guidance? Sources: - https://www.asphalion.com/news/anvisa-publishes-two-guidance-manuals-for-the-regularisation-of-medical-devices/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in Brazil and over 30 other markets, managing submissions and ensuring ongoing compliance. Our experts develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers, helping you navigate complex requirements like ANVISA's notification pathway. From initial market research to post-market surveillance, we ensure your products reach global markets faster. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and regulatory database at https://pureglobal.ai.
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    6 分
  • Singapore HSA's New Registration Pathway for Special Access Route (SAR) Devices

    Singapore HSA's New Registration Pathway for Special Access Route (SAR) Devices
    2026/09/06
    Singapore's Health Sciences Authority (HSA) launched a Registration Support Initiative on August 28, 2026, to help transition clinically important medical devices from the Special Access Route (SAR) to full market registration. This episode details the purpose of this new pathway, the eligibility criteria for devices serving small patient populations, the significant evaluation-fee waiver, and the inaugural application deadline of December 31, 2026. We provide practical steps for manufacturers to leverage this opportunity to secure a sustainable, registered supply route in Singapore. Key Questions: - What is Singapore's Special Access Route (SAR) and why is it not a long-term solution for market access? - What is the purpose of the new HSA Registration Support Initiative launched in August 2026? - Which medical devices are eligible to transition from SAR to full registration under this new pathway? - What are the key benefits for manufacturers, including the full waiver of evaluation fees? - What is the critical inaugural application deadline that companies must meet? - What evidence is needed to demonstrate a device's clinical importance for a small patient population in Singapore? - How does prior approval from a comparable overseas regulator impact eligibility for the initiative? - What practical steps should regulatory and market-access teams take now to prepare a submission? Sources: - https://gpc-gateway.com/2026/08/31/singapore-introduces-fee-supported-registration-pathway-for-clinically-important-medical-devices/ How Pure Global can help: Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. We act as a local representative in over 30 markets, develop efficient regulatory strategies, and use AI to compile and submit technical dossiers. Our services help you gain and maintain market access through continuous regulatory monitoring and post-market surveillance. Whether you are a startup or a multinational enterprise, Pure Global provides a single, efficient process to access multiple international markets. Learn more about our free AI tools and global database at https://pureglobal.ai, or contact us at info@pureglobal.com and https://pureglobal.com to accelerate your market entry.
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    5 分
  • UK MHRA Health Bill Amendments 2026: New Powers for Future Device Regulation

    UK MHRA Health Bill Amendments 2026: New Powers for Future Device Regulation
    2026/09/05
    The UK government has proposed three amendments to the Health Bill, introduced on September 1, 2026, that grant significant new powers to the MHRA. This episode breaks down what these changes—enhanced information sharing, agile regulatory updates via secondary legislation, and the foundation for a future UK-specific device licensing system—mean for medical device manufacturers. We discuss the strategic implications for companies relying on CE marking for UK market access and outline practical steps that regulatory and quality teams should take now to prepare for Great Britain's move toward a sovereign regulatory framework. Key Questions: - What new powers are proposed for the UK MHRA in the 2026 Health Bill? - How will the MHRA's ability to share information with the wider healthcare system change? - What does "agile regulation" mean for medical device manufacturers in the UK? - Is the UK moving away from reliance on the UKCA and CE marks for device approval? - When were these amendments introduced and what is the legislative timeline? - How do these changes affect companies currently using a CE mark for UK market access? - What foundational steps are being taken to create a future UK device licensing system? - What practical actions should regulatory teams take now to prepare for these changes? Sources: - https://www.gov.uk/government/news/mhra-regulatory-reform-amendments-tabled-in-governments-health-bill - https://medtech.pharmaintelligence.informa.com/MT151249/MHRA-May-Get-Wider-Device-Licensing-Powers-As-UK-Eyes-New-Regulatory-Regime - https://commonslibrary.parliament.uk/research-briefings/cbp-9999/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, simplifying access to over 30 global markets. Our experts develop efficient regulatory strategies, manage technical dossier submissions, and act as your local representative to ensure ongoing compliance. By combining in-country expertise with advanced AI, we help you navigate complex and evolving landscapes like the UK's move toward a sovereign system. Prepare your business for future requirements and accelerate your market entry with our technology-driven solutions. Visit us at https://pureglobal.com, contact us at info@pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.
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    4 分
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