Medical Device Adverse Event and Post-Market Risk Updates

Regulix tracks medical device adverse event monitoring and post-market risk requirements in China. Coverage examines risk assessment guidance and implementation changes, helping companies understand their ongoing responsibilities after market entry and plan effective monitoring, evaluation, and risk management activities.

China's NMPA Issues First-Ever Revision to Medical Device Adverse Event Risk Assessment Guidelines — 5-Part Framework Sets New Post-Market Compliance Standards

2026-05-05

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…

Medical Device Adverse Event and Post-Market Risk Updates

China's NMPA Issues First-Ever Revision to Medical Device Adverse Event Risk Assessment Guidelines — 5-Part Framework Sets New Post-Market Compliance Standards

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