Medical Device Global Market Access

Pure Global
  • 5.0 (1)
  • Technology

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.

  1. 5h ago

    Australia TGA Medical Device Fee Changes: What to Know for 2026 Audits

    Australia's Therapeutic Goods Administration (TGA) has updated its guidance on fee reductions for medical device conformity and ARTG application audits. Effective October 1, 2026, these changes introduce a new fee model for design examinations based on Unique Product Identifier (UPI) components, increase certain recertification fees, and raise the minimum fee for subsequent devices in mandatory audits. This episode details what these changes mean for manufacturers and how to prepare your regulatory strategy and budget. Key Questions: - How is the TGA changing its fee reduction model for design examinations? - What is the new fee reduction percentage for certain recertifications? - By how much is the minimum fee increasing for related devices in a mandatory audit? - When do these new TGA fee structures take effect? - What are Unique Product Identifier (UPI) component assessments and how do they impact costs? - Who is most affected by these changes to TGA conformity assessment fees? - What practical steps should manufacturers take to prepare their regulatory budgets? - How can sponsors strategically plan submissions under the new fee rules? Sources: - https://www.regconnect.medtech.org.au/september-28th-october-2nd-2026/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. For the Australian market, we offer local representation, develop efficient regulatory strategies for TGA submissions, and compile technical dossiers using advanced AI. Our team helps you navigate complex requirements like the TGA's updated fee structure to ensure compliant and cost-effective market entry and maintenance. We manage the entire lifecycle, from initial ARTG registration to post-market surveillance, ensuring your continued compliance. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

  2. 1d ago

    TGA AI Medical Scribe Regulation: When Clinical Software Becomes a Medical Device

    Australia's Therapeutic Goods Administration (TGA) has clarified that many AI-powered digital scribes are considered medical devices, not simple administrative tools. Following a review published on October 16, 2023, the TGA found that 8 of 12 reviewed products were likely unapproved medical devices. This episode breaks down the TGA's reasoning, focusing on how a software's intended purpose—such as summarizing or analyzing clinical information—triggers regulatory oversight. We discuss the immediate compliance obligations for manufacturers and provide practical steps for developers of Software as a Medical Device (SaMD) to navigate this evolving regulatory landscape. Key Questions: - What did the TGA's review of AI digital scribes reveal on October 16, 2023? - Why are some AI scribes now considered medical devices in Australia? - What is the key difference between an administrative tool and a Software as a Medical Device (SaMD)? - What immediate actions must manufacturers of unapproved AI scribes take? - How does a product's intended purpose affect its regulatory classification? - What are the steps for including an SaMD product in the Australian Register of Therapeutic Goods (ARTG)? - What risks do developers face if they continue to supply non-compliant software? - How can manufacturers conduct a gap analysis against TGA requirements? Sources: - https://www.racgp.org.au/newsgp/professional/ai-medical-scribes-face-stricter-tga-oversight - https://www.tga.gov.au/news/news/digital-scribe-review-outcomes How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you access global markets faster. For SaMD developers targeting Australia, we offer expert regulatory strategy, technical dossier preparation for TGA submissions, and local representation services to ensure your product meets all compliance requirements. Our combination of local expertise and advanced AI tools streamlines the path to market, from initial classification to post-market surveillance. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI-powered regulatory tools and global device database at https://pureglobal.ai.

  3. 2d ago

    Japan PMDA Generative AI Guidance: Key Review Points for Medical Device Manufacturers

    On October 14, 2026, Japan's PMDA published its draft guidance, 'Review Points for Medical Devices Utilizing Generative AI.' This episode explores the key safety and performance evaluation criteria that manufacturers must understand to successfully bring advanced AI-enabled medical devices to the Japanese market. We cover the PMDA's expectations for data quality, AI model lifecycle management, transparency, and risk management, providing practical steps for regulatory and quality teams to prepare for these new requirements. Key Questions: - What are the main review points in Japan's new PMDA draft guidance for generative AI medical devices? - How does this guidance impact manufacturers targeting the Japanese market? - What does the PMDA expect for training data quality and management? - How should companies address the risks of AI model drift and performance degradation? - What are the new requirements for AI transparency and explainability? - How can you adapt your risk management process for generative AI-specific hazards? - What practical steps should your regulatory and quality teams take now? - When was this important draft guidance released? Sources: - https://www.pmda.go.jp/english/whatsnew/default.html How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you access global markets faster. Our experts specialize in creating efficient regulatory strategies for novel technologies like AI-powered medical devices. We manage technical dossier preparation, submission, and local representation in over 30 countries, including Japan. By combining in-country expertise with advanced AI tools, we streamline the registration process, ensuring your innovative products meet complex requirements like the PMDA's new guidance. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free regulatory AI tools and database at https://pureglobal.ai.

  4. 3d ago

    Health Canada Medical Device Shortage Guidance: Exceptional Importation and Sale Updates

    Health Canada has released revised guidance on its framework for exceptional importation and sale of medical devices, effective October 16, 2026. This episode details the key clarifications for manufacturers facing potential device shortages, outlines the updated application requirements and responsibilities for importers, and highlights the upcoming stakeholder information session on October 21, 2026. We provide practical steps for regulatory and quality teams to adapt to these changes and leverage the framework as part of a robust supply chain strategy. Key Questions: - What is Health Canada's exceptional importation and sale framework for medical devices? - What are the most significant changes in the revised guidance published on October 16, 2026? - How does Health Canada now define a medical device 'shortage'? - What new obligations are placed on manufacturers, importers, and distributors? - How can my company apply for authorization under this framework? - Do these changes affect devices already on the market through exceptional importation? - What should our team do to prepare for the stakeholder session on October 21, 2026? - How can this framework be integrated into our company's risk management plan? Sources: - https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages/updated-guidance-documents.html How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies seeking to navigate complex markets like Canada. Our experts can help you develop a robust regulatory strategy, prepare technical submissions for frameworks like exceptional importation, and act as your local representative. We combine in-country expertise with advanced AI tools to streamline dossier preparation and ensure compliance with evolving regulations from Health Canada. Whether you are managing a potential shortage or planning your market entry, our end-to-end solutions are designed to accelerate your global market access. Contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI tools and global device database at https://pureglobal.ai.

  5. 4d ago

    FDA Draft Guidance for Robotically Assisted Surgical Devices: Premarket Submission Insights

    On October 9, 2026, the US FDA issued new draft guidance clarifying premarket submission requirements for robotically assisted surgical (RAS) devices. This episode breaks down the FDA's key recommendations for non-clinical testing, clinical evidence, software validation, cybersecurity, human factors, and labeling. We provide practical steps for manufacturers to align their 510(k), De Novo, or PMA submissions with the agency's current expectations to ensure a smoother path to market access. Key Questions: - What are the FDA's key expectations for non-clinical testing of robotic surgical systems? - How does the new draft guidance impact software and cybersecurity requirements for RAS devices? - What level of clinical evidence is needed for a 510(k) or PMA submission? - Why is human factors engineering a critical component of the FDA's review? - What specific information must be included in the labeling and training materials? - Who does this new FDA guidance apply to? - How should manufacturers prepare their premarket submissions in light of this guidance? - What are the next practical steps for regulatory and quality teams? Sources: - https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQGlbugOQBcIm3HyA2nJF9nBCBvSgBmREgA96rc1ijDH867RFXvcQID1ypv4pt5DFkqUCgXUSlfi7Q9PG_hLNyVef8ZqXbSUjsoMVcWQA5y0NSEAFknCVj50g3VWhr4EzDy515BBJfBU - https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQFVVn8ko2xzOxwTtZXu9kdpVGLOyjhMIEC1V7FwHSTUhjpr_f79bVavL-1Ay2Jxpi_W5cDMNzIZNXlFTfETJiRfhQrVveWAZVC-Csh4UXhoy4kPkxXKDijz6tscaQppObaA-xRLH8VbyhmM9ls How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies seeking to enter or expand in global markets. Our experts combine local regulatory knowledge with advanced AI tools to develop efficient market access strategies, compile and manage technical dossiers, and act as your in-country representative in over 30 markets. We help you navigate complex requirements from pre-submission to post-market surveillance, ensuring faster approvals and sustained compliance. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI tools and global device database at https://pureglobal.ai.

  6. 5d ago

    FDA GenAI Medical Device Regulation: Key Considerations Before the October 19, 2026 Comment Deadline

    The US FDA is considering a new 'total product lifecycle' approach for regulating medical devices that use Generative AI (GenAI). This episode breaks down the key elements of the FDA's discussion paper, including the unique risks the agency has identified, such as AI 'hallucinations' and automation bias. We discuss why this shift to continuous oversight is being proposed and what it means for manufacturers. Most importantly, we highlight the critical October 19, 2026, deadline for submitting public comment and provide practical steps your team can take now to prepare and help shape future policy. Key Questions: - What is the FDA's proposed regulatory framework for medical devices using Generative AI? - Why is a 'total product lifecycle' approach being considered for GenAI devices? - What specific risks, like hallucinations and automation bias, has the FDA identified? - Who is affected by these potential new regulations? - What is the significance of the October 19, 2026, feedback deadline? - How can manufacturers provide effective feedback to the FDA? - What practical steps should regulatory and quality teams take right now? - How might this framework impact future pre-market submissions and post-market surveillance? Sources: - https://www.medicaldevice-network.com/news/the-fdas-genai-proposal-evolving-regulation-for-an-evolved-medtech-era/ - https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/cdrh-new-news-and-updates How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex requirements like the FDA's evolving stance on AI. Our experts can assist with developing a robust regulatory strategy, preparing technical dossiers for submission, and implementing agile post-market surveillance plans aligned with a lifecycle approach. By combining local expertise with powerful AI and data tools, we streamline global market access and ensure continuous compliance. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI regulatory tools and product database at https://pureglobal.ai.

  7. 6d ago

    Singapore HSA-ACE Priority Track: Faster Market Access for Innovative Medical Devices

    Singapore's Health Sciences Authority (HSA) has announced a new priority pathway for innovative medical devices, launching in November 2026. The 'HSA-Agency for Care Effectiveness (ACE) Priority Track' enables simultaneous regulatory review by the HSA and Health Technology Assessment (HTA) by ACE. This episode breaks down how this parallel evaluation process aims to cut the time to a first HTA decision from one year to just six months post-approval, and what it means for manufacturers seeking faster market access and reimbursement in Singapore. Key Questions: - What is the new HSA-ACE Priority Track for medical devices in Singapore? - When will this new accelerated pathway become available to manufacturers? - How does the simultaneous review by HSA and ACE speed up market access? - What is the expected reduction in the timeline for a Health Technology Assessment (HTA) decision? - Which types of innovative medical devices are eligible for this priority track? - What are the strategic implications for a company's evidence generation plan? - How should regulatory and market access teams prepare for this new process? - Why is early engagement with both HSA and ACE now more important than ever? Sources: - https://www.channelnewsasia.com/singapore/hsa-healthcare-innovation-clinical-research-hub-priority-track-3840131 - https://indiplomacy.com/singapore-hsa-announces-three-initiatives-to-accelerate-clinical-research-and-healthcare-innovation/ - https://www.instagram.com/p/C_SgN45yS-T/ - https://healthcareasiamagazine.com/healthcare/news/sg-slashes-clinical-trial-red-tape-speeds-health-tech-reviews How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative and manage device registrations in over 30 countries, including key Asia-Pacific markets like Singapore. Our experts develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers, minimizing delays. For support with Singapore's new priority track or your broader global expansion, contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI-powered regulatory tools and extensive device database at https://pureglobal.ai to accelerate your research and planning.

  8. Oct 15

    South Korea MFDS Proposes Faster Class II Medical Device Certification

    South Korea's Ministry of Food and Drug Safety (MFDS) has proposed a new one-stop certification and technical review process for Class II medical devices. This episode breaks down the amendment, announced on September 14, 2026, which aims to cut total review times from 40 days to 25. We cover who is affected, the crucial public comment deadline of October 26, 2026, and practical steps manufacturers should take now to prepare for this streamlined market access pathway. Key Questions: - What is the new 'one-stop' certification process proposed by South Korea's MFDS? - Which specific device class does this proposed change affect? - How much faster could the market access process become for Class II devices? - What is the deadline for submitting public comments on this proposal? - Why is simultaneous submission of certification and technical documents a major change? - What are the immediate actions regulatory teams should take in response to this news? - How can manufacturers prepare their technical documentation for this new process? - Why is consulting with a local representative in South Korea important right now? Sources: - https://www.gca-korea.com/post/korean-mfds-to-introduce-a-one-stop-certification-and-review-process-for-class-ii-medical-devices How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies seeking to enter or expand in over 30 global markets, including South Korea. Our team of local experts, supported by advanced AI technology, can help you navigate the MFDS regulatory landscape, act as your in-country representative, and prepare technical dossiers for efficient submission. We streamline the registration process, allowing you to access multiple markets with a single, coordinated strategy. For support with your South Korea market access plan, contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and device database at https://pureglobal.ai.

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About

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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