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  • GDTE 2026 to Open in Hangzhou With MedTech Zone Focused on AI Export Compliance
    GDTE 2026 to Open in Hangzhou With MedTech Zone Focused on AI Export Compliance
    GDTE 2026 in Hangzhou launches a MedTech zone for AI medical export, highlighting FDA, CE and MDSAP compliance, clinical validation and global market entry support.
  • China Issues SaMD Implementation Rules, Clarifying Export Compliance for AI Medical Software
    China Issues SaMD Implementation Rules, Clarifying Export Compliance for AI Medical Software
    China SaMD implementation rules clarify export compliance for AI medical software, covering classification, clinical validation, and cross-border data. Learn what it means for global buyers.
  • China Imposes Temporary Export Ban on Helium, Disrupting Medical Cooling Supply Chains
    China Imposes Temporary Export Ban on Helium, Disrupting Medical Cooling Supply Chains
    Helium export ban in China threatens medical cooling supply chains, impacting MRI, surgical robots, and tele-ICU systems.
  • EU Tightens SaMD Audit and Edge AI Log Rules
    EU Tightens SaMD Audit and Edge AI Log Rules
    EU Tightens SaMD Audit and Edge AI Log Rules: learn how the new EU guidance affects CE compliance, 90-day edge log retention, and deployment design for SaMD vendors.
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