Notice of the General Department of the State Food and Drug Administration on Further Doing a Good Job in the Demonstration and Promotion of the Unique Identification of Medical Devices

The Drug Administration of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps, and all relevant units:

The unique identification system for medical devices is an important measure to implement the "Regulations on the Supervision and Administration of Medical Devices", and effectively promote the reform of the State Council to control high-value medical consumables and the State Council to deepen the reform of the medical and health system. It is an important means to optimize management and promote the high-quality development of the industry. Since the implementation of the first batch of unique identifications for medical devices on January 1, 2021, the unique identifications have been successfully demonstrated and applied in the entire chain of medical device production, circulation and use, which has effectively promoted the entire process of medical devices from source production to clinical use. Chain linkage.

In order to further improve the demonstration and promotion of unique identification, the State Food and Drug Administration organized experts in the fields of medicine, health, and medical insurance to carry out the selection of unique identification demonstration units. The first batch of 15 demonstration units of unique identification of medical devices were selected based on their advanced level.

Each unique identification implementation demonstration unit should further expand the implementation and application of the unique identification, actively connect with upstream and downstream, and strengthen the linkage of the entire chain of the unique identification; it is necessary to further summarize experience, form a long-term mechanism, continuously improve the work level, and effectively play a leading demonstration role; A fixed person is responsible, and a training plan is reasonably formulated according to the training needs, and the unique identification training and observation and learning are carefully organized, and cooperation and exchanges between demonstration units are encouraged to further improve the effect of demonstration applications. Bureau.

The drug administrations of all provinces (autonomous regions and municipalities) should strengthen demonstration and leadership, actively promote the construction of unique identification demonstration projects in their jurisdictions, formulate annual work plans, make full use of unique identification to implement demonstration units, and expand areas by point and area, and solidly promote the effective implementation of the unique identification system. . The demonstration and promotion work will be reported to the State Food and Drug Administration before the end of the year.