MEDTECH NEWS
NMPA Issues Inspection Guidelines for Newly Revised Medical Device Production Quality Management Regulations
17 09 2026China's National Medical Products Administration (NMPA) has issued Notice No. 14 of 2026, releasing new inspection guidelines aligned with the revised Medical Device Production Quality Management Regulations (GMP), which take effect November 1, 2026. The guidelines replace the 2015 version and set out transition arrangements, risk-based post-market inspection requirements, and specify that sterile, implantable, IVD reagent, custom denture, and standalone software devices must comply with both the new GMP and existing appendix requirements.