In order to strengthen the supervision of the whole life cycle of medical devices and promote the realization of “three medical linkages”, recently, the Autonomous Region Food and Drug Administration, together with the Autonomous Region Health Commission, the Medical Insurance Bureau, and the Public Resource Exchange Bureau jointly The “Work Plan on Promoting the Implementation of the Unique Identification of Medical Devices” was issued, and efforts were made to do a good job in the demonstration and promotion of the unique identification of medical devices in our district.
The “Plan” clearly requires that by supporting the demonstration application of the unique identification of medical devices in the production, operation and use links, create conditions for the demonstration and promotion of the whole region, establish a model, and further promote In-depth implementation of unique identifiers. At the same time, in view of the fact that there is currently no unique identification pilot product announced by the state in our region, it is proposed to select the second-class medical device registrants with mature conditions in the region to try first, so as to implement the unique identification designation for the next step for medical device manufacturers in our region. Code work provides experience. In the business process, relatively large-scale medical device operating companies and third-party logistics distribution companies will be selected to carry out unique identification scanning first, and gradually promote the application of the third-class medical device operating companies in the region. At the same time, it will actively promote the qualified and willing public hospitals and other user units to participate in the implementation of the unique identification system, study and solve the connection and application of the unique identification in the fields of medicine, medical care, medical insurance, etc., and truly promote the whole chain collaboration to achieve The quality of medical device products is traceable from the source production to clinical use.
In the next step, our district will take the opportunity to implement the requirements of the “Plan” to further increase the publicity of the unique identification policy, consolidate the effectiveness of the implementation of the unique identification work in a timely manner, and develop Various forms of , targeted training, forming a data sharing mechanism for joint participation and sharing of results, to ensure the smooth implementation and promotion of unique identification, and to effectively protect medical devices The quality and safety can be traced back to improve the efficiency of supervision work.