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Medical Device Global Market Access

Medical Device Global Market Access

Written by: 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
Episodes
  • EU MDR Clinical Investigations: Navigating Deadlines and Data Requirements for European Market Access

    EU MDR Clinical Investigations: Navigating Deadlines and Data Requirements for European Market Access
    Jan 8 2026
    This episode provides a detailed overview of the clinical investigation requirements under the European Union's Medical Device Regulation (MDR). We explore the critical distinctions between pre-market clinical investigations and post-market clinical follow-up (PMCF), the role of the Clinical Evaluation Report (CER) as a living document, and the key transitional deadlines that manufacturers of legacy devices must meet to maintain market access. We also touch on the function of the EUDAMED database in enhancing transparency. - What are the primary differences between clinical data requirements under the old MDD and the current MDR? - How does the MDR define a pre-market clinical investigation versus a post-market clinical follow-up (PMCF) study? - What were the critical compliance actions required by the May 26, 2024, deadline for legacy devices? - What is the significance of the September 26, 2024, deadline for agreements with Notified Bodies? - Why is the Clinical Evaluation Report (CER) now considered a living document that requires continuous updates? - What are the final transition deadlines for different device risk classes to become fully MDR compliant? - How will the EUDAMED database impact the transparency of clinical investigations in the EU? - What are the general requirements for reporting serious adverse events during a clinical investigation under the MDR? Navigating the EU MDR's stringent clinical evidence requirements demands deep regulatory expertise. Pure Global provides end-to-end consulting for MedTech and IVD companies, leveraging local experts and advanced AI to streamline global market access. We develop efficient regulatory strategies, use AI to compile technical dossiers, and act as your local representative to ensure you meet all pre-market and post-market obligations. To learn how we can accelerate your entry into over 30 global markets, visit us at https://pureglobal.com/, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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    4 mins
  • Navigating COFEPRIS: A Guide to Dental Device Registration and Market Access in Mexico

    Navigating COFEPRIS: A Guide to Dental Device Registration and Market Access in Mexico
    Jan 7 2026
    This episode provides a comprehensive guide to the regulatory landscape for dental devices in Mexico. We delve into the role of the national regulatory body, COFEPRIS, and explore the classification system for dental equipment and supplies. The discussion covers the essential requirements for market entry, including the mandatory appointment of a Mexican Registration Holder (MRH), the different registration pathways available—such as the Standard and Equivalency routes—and the critical importance of post-market technovigilance for maintaining compliance. Key Questions: - What is COFEPRIS and what is its role in regulating dental devices in Mexico? - How are dental devices classified according to risk in the Mexican market? - What is a Mexican Registration Holder (MRH) and why is it essential for foreign manufacturers? - What are the primary regulatory pathways for getting a dental device approved in Mexico? - Can approvals from the FDA or Health Canada expedite the registration process in Mexico? - What are the post-market surveillance and technovigilance requirements? - How often do sanitary registrations need to be renewed? - What recent regulatory updates impact dental device registration in Mexico? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with a unique blend of local expertise and advanced AI tools. We act as your local representative in over 30 markets, developing efficient regulatory strategies and using AI to compile and submit technical dossiers. Our services ensure your products get to market faster and maintain compliance. For startups, scaleups, or multinational enterprises, Pure Global provides tailored solutions to navigate complex regulatory environments. 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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    3 mins
  • Accessing Mexico's Dental Market: A Guide to COFEPRIS Regulatory Approval

    Accessing Mexico's Dental Market: A Guide to COFEPRIS Regulatory Approval
    Jan 6 2026
    This episode provides a detailed guide for dental device manufacturers on navigating the regulatory landscape in Mexico. We cover the role of the national authority, COFEPRIS, the critical process of appointing a Mexico Registration Holder (MRH), device classification, and the strategic advantages of using the Equivalency Pathway for faster market approval. We also discuss essential post-market obligations, including Technovigilance and registration renewal. - What is the role of COFEPRIS in regulating dental devices in Mexico? - Why is a Mexico Registration Holder (MRH) essential for foreign manufacturers? - How are dental devices classified according to Mexican regulations? - Can existing FDA or CE approvals accelerate the registration process in Mexico? - What is the Equivalency Pathway and how does it work? - Are there specific language requirements for device labeling and documentation? - What is Technovigilance and what are my post-market responsibilities? - How long is a device registration valid in Mexico and how is it renewed? Pure Global offers end-to-end regulatory solutions to get your medical technology to market faster. Our experts act as your local representative in over 30 markets, including Mexico, managing the entire registration process with COFEPRIS. We develop efficient regulatory strategies, leverage existing approvals to accelerate timelines, and use advanced AI to compile and submit your technical dossier. After approval, we ensure ongoing compliance through continuous monitoring and post-market surveillance. To learn how we can become your trusted partner for market access, contact us at info@pureglobal.com, visit https://pureglobal.com/, or explore our FREE AI tools at https://pureglobal.ai/.
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    3 mins
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