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    • ZLG Updates Sterilization Cloud Access List: 21-Day API Audit Window for Chinese Vendors
      ZLG updates Sterilization Cloud access: Chinese vendors must complete ISO/IEC 27001 API audit by June 10, 2026—protect CE marking & EU market access now.
      May 21, 2026
      Dr. Alistair Thorne (Senior Biomedical Engineer)
    • ISO 13485:2026 Published: AI Remote Audit Mandatory
      ISO 13485:2026 is live — AI remote audit now mandatory for medical device certification from 1 Oct 2026. Discover what it means for manufacturers, CBs & tech providers.
      May 21, 2026
      Dr. Julian Rossi (RehabTech Specialist)
    • FDA Warning Letters Target Centrifugation Tech Rotor Traceability
      FDA warning letters target Centrifugation Tech rotor traceability—urgent for medical device & IVD exporters. Verify melt furnace numbers, heat curves, NDT data now.
      May 21, 2026
      Dr. Hideo Tanaka (Imaging Systems Analyst)
    • Medical Device Slot Premium Drops to +28% on Far East–North Europe Route
      Medical Device Slot premium drops to +28% on Far East–North Europe route—driven by AI customs clearance & port stability. Optimize regulatory-ready shipping now.
      May 21, 2026
      Dr. Julian Rossi (RehabTech Specialist)
    • MFDS Expands Smart Orthotics Exemption to Include China's GB/T 24625-2025
      MFDS now accepts China's GB/T 24625-2025 for smart orthotics — skip redundant biocompatibility testing, cut costs & accelerate Korea market entry.
      May 21, 2026
      Sarah Jenkins (Laboratory Infrastructure Consultant)
    • PMDA Accelerates AI Ultrasound Module Approval with GB/T 39827-2025 Acceptance
      PMDA accepts GB/T 39827-2025 for AI ultrasound modules — fast-track Japan approval in just 4.2 months. Discover how Chinese developers gain competitive edge.
      May 21, 2026
      Lydia Vancini (Regulatory Compliance Lead)
    • EU CE Update: Vital Sign Sensors Require IEC 62304:2026 Class C Software Certification
      EU CE Update: Vital sign sensors now require IEC 62304:2026 Class C software certification—critical for OEMs, importers & notified bodies entering the EU market.
      May 21, 2026
      Lydia Vancini (Regulatory Compliance Lead)
    • ASEAN MDSR Phase II: Blockchain-Verified Cold Chain Data for Bio-Sample Storage
      ASEAN MDSR Phase II mandates blockchain-verified cold chain data for bio-sample storage—act now to ensure compliance by 15 June 2026!
      May 21, 2026
      Dr. Hideo Tanaka (Imaging Systems Analyst)
    • FDA Finalizes SBOM Mandate for Remote Monitoring Devices
      FDA's SBOM mandate for remote monitoring devices is live—learn how to comply with SPDX/CycloneDX requirements, avoid submission delays, and turn cybersecurity transparency into competitive advantage.
      May 21, 2026
      Lydia Vancini (Regulatory Compliance Lead)
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