NMPA Releases Revised Medical Device GMP, Effective November 2026
In order to strengthen the quality management of medical device production, standardize manufacturing activities, promote the disciplined development of the industry, and ensure the safety and effectiveness of medical devices for public use, the National Medical Products Administration (NMPA) has revised the Good Manufacturing Practice for Medical Devices (GMP). This revision is conducted in accordance with the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production, and other relevant laws and regulations.

The revised Good Manufacturing Practice for Medical Devices is hereby released and will come into effect  on November 1, 2026. Simultaneously, the Announcement on the Issuance of the Good Manufacturing Practice for Medical Devices (No. 64 of 2014) previously issued by the former China Food and Drug Administration (CFDA) shall be repealed.

Annex: Good Manufacturing Practice for Medical Devices (Chinese version only)

 

Reference

Announcement of the National Medical Products Administration on the Issuance of the Good Manufacturing Practice for Medical Devices (No. 107 of 2025) (Chinese version only)