Acceptance of medical device regulatory reliance is growing, not just for use during healthcare emergencies like COVID, but in routine, everyday practice.
Trunzo: ’We’ve Come A Long Way To Get To Regulatory Reliance’
21st Century Regulatory Best Practice In The Making
Medical device regulatory reliance and recognition of third-party regulators’ approvals have been making news in the UK, but in certain other markets the practice is well established. International regulatory experts explained their experiences at the MedTech Forum 2024.
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The International Medical Device Regulators Forum discussed AI regulation, the development of a reliance playbook, and post-market regulation at the group's annual meeting in Tokyo last week. While the US FDA was not on-site, the agency was able to participate virtually.
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Zydus Lifesciences plans to expand global markets for patented products of French orthopedic tech company Amplitude Surgicals which it is acquiring from PE firm PAI Partners and others. Could the European business also serve as a buffer to upheaval in the US amid talks of tariffs?
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In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.
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China's medical equipment industry is growing rapidly, driven by limited domestic presence in high-cost segments and increasing adoption of local products in areas like monitoring equipment, defibrillators, and ventilators. International giants dominate the high-end market, but domestic companies such as Neusoft Medical Systems and Mindray Medical are making significant strides.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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Abbott presented late-breaking data at the 2025 American College of Cardiology conference demonstrating that TriClip transcatheter edge-to-edge repair offers prolonged patient benefits compared to medical treatment alone after two years, which were not evident at one year.