Release date: 2023-12-07
In order to strengthen the quality management of medical device operations, standardize medical device operations, promote the development of industry standards, and ensure the safety and effectiveness of medical devices used by the public, in accordance with relevant laws and regulations, the China NMPA has revised the “Quality Management Specifications for Medical Device Operations”. Effective from July 1, 2024, the former NMPA’s “Announcement on the Implementation of Quality Management Specifications for Medical Device Operations” (2014 No. 58) will be abolished at the same time.