To strengthen the quality management of medical device manufacturing, regulate medical device manufacturing activities, promote normative development of the industry, and ensure the safety and effectiveness of medical devices for the public, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and the "Provisions for Supervision and Administration of Medical Device Manufacturing", the National Medical Products Administration has revised the Good Manufacturing Practice for Medical Devices. It is hereby released and shall come into force as of November 1, 2026. The previous announcement "Announcement on the Release of the Good Manufacturing Practice for Medical Devices ([2014] No. 64) by the former China Food and Drug Administration shall be simultaneously repealed.

It is hereby announced.

National Medical Products Administration

November 4, 2025