CMDE Adds 128 IVD Hardware Items to Clinical Trial Exemption List, opening a faster China registration path for eligible POCT devices. See impacts, timelines, and compliance opportunities.

Japan PMDA now accepts GB/T 39827-2025 clinical data for AI ultrasound metrics — slashing approval time to 45 days. Accelerate your Japan market entry today.

PMDA accelerates AI ultrasound module approval via China’s GB/T 39827-2025 — cut review time from 18 to 6 months. Learn how NMPA-cleared devices qualify.

PMDA launches fast-track for Ultrasound Metrics AI algorithms—45-day review for NMPA Class III–certified AI tools. Act now to accelerate Japan market entry.