『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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概要
 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
エピソード
  • Brazil ANVISA Recognized Technical Standards: New Lists for Orthopedic and Health-Use Materials

    Brazil ANVISA Recognized Technical Standards: New Lists for Orthopedic and Health-Use Materials
    2026/11/04
    On October 22, 2026, Brazil's ANVISA released three workbooks of recognized technical standards impacting medical device manufacturers. This episode details the contents of the new "Transversal Standards" (v1.0) and "Health-Use Materials" (v0.0) lists, as well as the updated "Orthopedic Implantable Materials" (v1.1) list. We explain how voluntary compliance with these standards can create a presumption of conformity, potentially streamlining the review of technical dossiers. We cover which device categories are affected and provide practical steps for regulatory teams to perform a gap analysis and update their submission strategies for the Brazilian market. Key Questions: - What are the three new technical standard lists ANVISA published on October 22, 2026? - How do these recognized standards impact the review process for medical device submissions in Brazil? - Which specific device types are affected by the new lists for orthopedic and health-use materials? - What is the significance of the new "transversal standards" list for all device manufacturers? - Is compliance with these ANVISA-recognized standards mandatory? - How can referencing these standards streamline your technical dossier preparation? - What practical steps should your regulatory team take in response to these updates? - Why is it important to monitor these ANVISA workbooks for future versions? Sources: - https://www.pure-global.com/insights/anvisa-publishes-three-recognized-device-standards-lists How Pure Global can help: Pure Global provides end-to-end regulatory consulting to help MedTech companies access global markets faster. Our experts can help you navigate complex regulatory changes, such as ANVISA's new recognized technical standards, by developing a clear market access strategy, performing gap analyses, and compiling robust technical dossiers that meet local requirements. With a presence in over 30 countries, we act as your local representative and ensure ongoing compliance. Visit us at https://pureglobal.com or contact us at info@pureglobal.com. Explore our free AI regulatory tools and global device database at https://pureglobal.ai to streamline your research and submissions.
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    5 分
  • South Korea MFDS Proposes 'One-Stop' Certification for Class II Medical Devices

    South Korea MFDS Proposes 'One-Stop' Certification for Class II Medical Devices
    2026/11/03
    South Korea's Ministry of Food and Drug Safety (MFDS) has proposed a significant amendment to streamline the certification process for Class II medical devices. This episode details the new 'one-stop' pathway, which combines the technical document review and certification application into a single, simultaneous submission to the National Institute of Medical Device Safety Information (NIDS). We explore how this change is expected to reduce the total processing time from approximately 40 days to 25 days and offer practical advice for manufacturers to prepare for this accelerated market access route following the closure of the public comment period on October 26, 2026. Key Questions: - What is South Korea's MFDS proposing for Class II medical device certification? - How does the new 'one-stop' process differ from the current sequential system? - What is the expected reduction in review time for Class II devices? - What is the role of the National Institute of Medical Device Safety Information (NIDS) in the new process? - When did the public comment period for this proposed amendment close? - How can manufacturers prepare their technical documentation for this potential change? - Why is a complete and accurate initial submission more critical under a simultaneous review process? - What practical steps should regulatory teams take to leverage this accelerated pathway? - How could this change impact market entry timelines and commercial strategy? Sources: - https://www.gca-korea.com/post/korean-mfds-to-introduce-a-one-stop-certification-and-review-process-for-class-ii-medical-devices - https://www.youtube.com/watch?v=example_placeholder_for_25 How Pure Global can help: Pure Global streamlines global market access for MedTech and IVD companies. For South Korea, we act as your local representative, manage interactions with the MFDS and NIDS, and prepare your technical dossier for submission. Our experts can help you navigate the proposed 'one-stop' certification process for Class II devices, ensuring your submission is complete and accurate to maximize the benefits of the accelerated timeline. We combine local expertise with advanced AI to get your products to market faster. Visit https://pureglobal.com, email us at info@pureglobal.com, or explore our free AI tools and device database at https://pureglobal.ai.
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    5 分
  • FDA IDE Electronic Submission Guidance: Preparing for the New Template

    FDA IDE Electronic Submission Guidance: Preparing for the New Template
    2026/11/02
    This episode covers the US FDA's new draft guidance, released on October 27, 2026, which introduces a standardized 'Electronic Submission Template for Investigational Device Exemption (IDE) Applications.' We discuss the FDA's goals of improving submission consistency and review efficiency, the key components of the proposed template, and who will be most affected. We also highlight the critical December 28, 2026, deadline for industry feedback and provide practical steps for regulatory and clinical teams to prepare for this upcoming change. Key Questions: - What is the new FDA draft guidance on IDE electronic submissions? - Why is the FDA introducing a standardized template for IDE applications? - Who will be most affected by this proposed change? - What is the critical deadline for providing feedback to the FDA on this draft guidance? - How does the new template aim to improve the IDE review process? - What are the key sections of the proposed electronic submission template? - What practical steps should regulatory teams take in response to this draft guidance? - How can sponsors prepare their internal processes for this new format? Sources: - https://www.federalregister.gov/documents/2026/10/28/2026-23501/electronic-submission-template-for-investigational-device-exemption-ide-applications-draft - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-investigational-device-exemption-ide-applications - https://www.fda.gov/medical-devices/news-events-medical-devices/cdrh-new-news-and-updates How Pure Global can help: Pure Global provides end-to-end regulatory consulting to help MedTech companies access global markets faster. Our experts can help you navigate the new FDA IDE submission requirements, develop an efficient regulatory strategy for your US clinical trials, and compile your technical dossier using advanced AI tools. We act as your local representative and ensure your submissions are complete and compliant to minimize delays. For support with your market access strategy, visit us at https://pureglobal.com or contact us at info@pureglobal.com. Explore our free AI regulatory tools and device database at https://pureglobal.ai.
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    5 分
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