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    • China's MedTech License-out Hits $59.6B in Q1 2026
      China's MedTech License-out hits $59.6B in Q1 2026 — discover how AI diagnostics, microfluidic IVD, and regulatory readiness are reshaping global health innovation.
      May 25, 2026
      Lydia Vancini (Regulatory Compliance Lead)
    • Medical Device Slot Premium +41% on Far East–Rotterdam Route
      Medical Device Slot Premium +41% on Far East–Rotterdam route—driven by AMS’s new cold-chain inspection system. Act now to avoid delays & cost spikes.
      May 25, 2026
      Dr. Hideo Tanaka (Imaging Systems Analyst)
    • ISO 13485:2026 Annex A Revision Launched for AI Remote Audits
      ISO 13485:2026 Annex A revision introduces AI remote audits—cloud video witnessing, digital twin verification. Essential for medical device manufacturers, suppliers & certifiers navigating global compliance.
      May 25, 2026
      Dr. Julian Rossi (RehabTech Specialist)
    • ZLG Extends API Security Audit Deadline for Sterilization Systems to 2026-06-15
      ZLG extends API security audit deadline for sterilization systems to 2026-06-15 — critical for CE-marked hydrogen peroxide plasma sterilizers, OAuth 2.0, and audit log encryption compliance.
      May 25, 2026
      Dr. Alistair Thorne (Senior Biomedical Engineer)
    • Australia's New RCM Rules for Vital Sign Sensors Take Effect
      Australia's new RCM rules for vital sign sensors take effect 23 May 2026—dual safety & EMC documentation now mandatory. Act now to avoid delays.
      May 25, 2026
      Lydia Vancini (Regulatory Compliance Lead)
    • MFDS Expands Smart Orthotics Exemption to Include YY/T 0640-2025
      MFDS expands smart orthotics exemption to include YY/T 0640-2025—unlock faster 8-week Korean registration for compliant Chinese devices. Act now!
      May 25, 2026
      Sarah Jenkins (Laboratory Infrastructure Consultant)
    • ASEAN MDSR Bio-Sample Storage Rules Go Live
      ASEAN MDSR bio-sample storage rules are live: blockchain-verified temperature monitoring now mandatory for market access in Indonesia, Vietnam & beyond—act before renewal deadlines!
      May 25, 2026
      Dr. Hideo Tanaka (Imaging Systems Analyst)
    • FDA Upgrades Centrifugation Tech Regulation: Global Suppliers Must Enable Rotor Material Batch API Traceability
      FDA mandates real-time rotor material batch API traceability for centrifugation devices—global suppliers must act now to meet October 2026 U.S. compliance.
      May 25, 2026
      Dr. Hideo Tanaka (Imaging Systems Analyst)
    • New China Export Certificate Rules for Med Devices Take Effect May 1, 2026
      New China export certificate rules for medical devices take effect May 1, 2026—learn how Class I/II risk-based certification impacts IVD hardware, sensors, EU MDR, and global market access.
      May 25, 2026
      Dr. Hideo Tanaka (Imaging Systems Analyst)
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