Market Pathways | MedTech Regulatory & Policy
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Exploring the people, challenges, and opportunities impacting the global #medtech regulatory, reimbursement and policy communities. Likes,RTs,etc ≠ endorsement.
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Joined April 2019
Be the expert in the room. @Market_Pathways delivers the policy, regulation, and #reimbursement insights you need. Start your free trial today:
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Singapore is streamlining #medtech market entry with regulatory, #cybersecurity, and procurement advances. Read the latest Global Spotlight in @Market_Pathways:
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In this week’s Pathways Picks: Malaysia and Singapore sign a #regulatory reliance agreement; China drafts real-world data standards; a guide on stents from South Korea and one on AI/ML from South Africa; Chile bulks up device program with new funding; Canada launches new eSTAR
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NOW AVAILABLE: FDA Output, August 2025. Novel #FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in August 2025. Updated August 25:
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NTAP awards hit a record in FY 2026—20 devices received bonus payments, all via the Breakthrough pathway. This marks a major shift in how hospitals adopt new technologies. Read and learn more here: #MedTech
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EU MDR data expectations, DOJ’s new data security rule, UK’s CE-mark recognition proposal, and FDA fees on the rise—global policy shifts are reshaping #medtech. The August 2025 issue of Market Pathways unpacks what companies need to know now:
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#Medtech regulations are shifting fast. The Market Pathways Article Pack gives you exclusive insights on policy, #reimbursement, and approvals—so you stay ahead of the curve. Download for free here:
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FDA #device user fees are rising again—FY 2026 includes a 23% hike in facility registration fees. But with staff cuts and a hiring freeze, will higher fees actually improve review performance? Here’s what industry needs to know:
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RT @RAPSorg: Yale experts urge reforming – not gutting – PDUFA.
raps.org
@User fees remain critical for supporting the FDA@s key regulatory operations,@ Ziaks and colleagues wrote. @Reforms could be considered as part of the ongoing reauthorization process to enhance...
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RT @Market_Pathways: Compliance isn’t just about risk—it’s about trust. Melissa Bianchi (@HoganLovells) breaks down the DOJ’s new Data Secu….
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RT @Market_Pathways: Get the #medtech market access insights you need—free. Our Regulatory-Focused Article Pack features five top-read @Mar….
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RT @Market_Pathways: Stay ahead in #medtech. Get your free feature article from @Market_Pathways for:.• Expert market access analysis.• K….
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Mark Leahey of @medicaldevices calls @Market_Pathways a key voice for #medtech innovation, patient care & industry growth. Now it’s your turn—share your feedback so we can keep delivering the insights that matter most:
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Stay ahead in #medtech. Get your free feature article from @Market_Pathways for:.• Expert market access analysis.• Key regulatory updates.• Strategic intel for your edge. Sign up and download here:
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RT @RAPSorg: Become a presenter at #RAPSEuroConvergence – a uniquely European event. Share your expertise on the topic that matters most to….
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US DOJ’s Data Security Program is reshaping how #medtech handles China-bound #data. Enforcement began July 8, 2025. Learn what these rules mean and how to stay compliant, with insights from Melissa Bianchi of @HoganLovells:
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RT @AdvaMedEvents: Heading to #MedTechCon by @AdvaMedUpdate this October? . Be sure to stop by Booth 1213 to say hello to @MedTechStrat, th….
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Get the #medtech market access insights you need—free. Our Regulatory-Focused Article Pack features five top-read @Market_Pathways articles on policy, #reimbursement, and regulation. Download for free here:
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