NMPA Medical Device Guidance Updates and Regulatory Insights

Regulix tracks new and revised NMPA guidance for medical devices, focusing on technical requirements, scope, and implementation. Coverage helps companies interpret regulatory expectations for review and risk management and assess how updated guidance affects their existing compliance work.

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…

NMPA Medical Device Guidance Updates and Regulatory Insights

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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