It is hereby announced that in order to strengthen the quality management of medical device business, standardize the behavior of medical device business, promote the standardized development of the industry, and ensure the safety and effectiveness of medical devices used by the public, the National Medical Products Administration, according to the applicable rules and regulations, has revised the Quality Management Practices for Medical Device Business, which is hereby promulgated and shall come into force as of July 1, 2024, and the former Announcement on Implementation of Quality Management Practices for Medical Device Business (No. 58, 2014) issued by China Food and Drug Administration shall be abolished simultaneously.
Annex: Quality Management Practices for Medical Device Business
National Medical Products Administration
December 4, 2023
Source: National Medical Products Administration
Annex: Quality Management Practices for Medical Device Business
National Medical Products Administration
December 4, 2023
Source: National Medical Products Administration