Medical Devices Compliance News
Latest policy and regulatory updates (2026)
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Liaoning Clarifies Medical Device Innovation Service Scope and Pre-Review Targets
- Medical Devices
- September 23, 2026
Liaoning's medical device innovation service guide: eligibility, access channels and dossier pre-review targets, separate from statutory approval timelines.
Liaoning Sets Out 10 Measures to Accelerate Medical Device Review
- Medical Devices
- September 17, 2026
Liaoning's 10-point list accelerates eligible device reviews and specifies conditional dossier and quality-system review relief. Regulix
China Clarifies Seven UDI Exemption Categories and Special Labeling Cases
- Medical Devices
- September 17, 2026
NMPA clarifies UDI exemptions, direct marking for reusable devices and electronic identification for standalone software. Regulix
China Sets 2027 and 2029 Milestones for Broader Medical Device UDI Coverage
- Medical Devices
- September 17, 2026
China sets phased UDI requirements for remaining device categories, including registration-system submissions and database updates. Regulix
7 Key Requirements Clarify China’s Medical Device Reclassification Pathway
- Medical Devices
- June 3, 2026
Regulix explains NMPA Announcement No. 52 of 2026, outlining China’s requirements for medical device reclassification, registration, filing, renewals, amendmen…
China's NMPA Issues First-Ever Revision to Medical Device Adverse Event Risk Assessment Guidelines — 5-Part Framework Sets New Post-Market Compliance Standards
- Medical Devices
- May 5, 2026
China's NMPA released the 2026 revised guidelines for medical device adverse event risk assessment on April 8, introducing new risk language aligned with ISO 1…