China NMPA Seeks Public Comment on Revised GMP Inspection Guidelines for Standalone Software

On September 30, 2026, the National Medical Products Administration released a draft for public comment: the Guidelines for GMP Inspection of Standalone Software (Draft for Comment). This revision updates the 2020 version (NMPA Comprehensive Medical Device Management [2020] No. 57) to align with the latest Medical Device Production Quality Management Standards (GMP) and the Appendix for Standalone Software.

Key highlights from the draft:

• 203 inspection items in total — 41 critical, 95 major, and 67 general.

• Full lifecycle coverage: design and development, risk management, configuration management, traceability analysis, cybersecurity, software release, deployment, and decommissioning.

• Integration of GMP requirements with software-specific controls, including off-the-shelf software (OTS), open-source licensing, and network security assurance.

• Clarified roles for legal representatives, management representatives, and quality department heads in software production.

Deadline for comments: October 13, 2026

Send your feedback to: mdgmp@cfdi.org.cn

Email subject: “Feedback on the Guidelines for GMP Inspection of Standalone Software”

This is a critical update for standalone software registrants, contract manufacturers, and anyone involved in medical device software compliance in China. Don’t miss the window to shape the final guideline.