China NMPA Draft GMP Inspection Guideline: Risk-Based Audits and Critical Check Items

Medical Device Global Market Access · Jul 23, 2026 · 5m

China's NMPA has released a draft 'Guideline for Inspection under the Medical Device Good Manufacturing Practices', signaling a major shift towards a risk-based, lifecycle-oriented audit approach. This episode breaks down the implications of this new framework, released for comment on June 9, 2026. We detail the importance of the 39 newly designated "critical check items" and explain how a failure in any one of these areas could lead to severe regulatory consequences. We also provide practical, actionable steps for manufacturers to prepare their quality management systems for these more…