China News Service Tianjin, May 27 (Reporter Zhang Daozheng) Tianjin Drug Administration, Tianjin Medical Security Bureau, and Tianjin Health Commission jointly released the "Tianjin Medical Device Unique Identification System Pilot Work Plan", which aims to comply with the law Promote the implementation of Tianjin's medical device unique labeling system rules, improve the efficiency of medical device supervision and hygiene management, standardize medical service behavior, strengthen the material control capability of medical protective medical devices and other products required for the prevention and control of new coronary pneumonia epidemic, and effectively protect public weapons Safety.
According to the unified deployment of the "Pilot Work Program for the Unique Identification System of Medical Devices" jointly issued by the State Drug Administration and the National Health and Health Commission, in conjunction with the "Notice on Doing the First Batch of Implementation of the Unique Identification of Medical Devices" by the State Drug Administration In accordance with the relevant requirements of Tianjin Municipality, Tianjin Food and Drug Administration has innovatively proposed a pilot operation mode for the unique identification (UDI) system of medical devices around the "three medical linkages". On the basis of several meetings, visits, investigations, and training in the early stage, the organization organized enterprises to carry out code assignment work, combined with the use of anti-epidemic materials used in the new coronary pneumonia epidemic, and worked together with Tianjin Medical Insurance Bureau and Tianjin Health and Health Commission to develop the ".
It is understood that the first batch of 16 medical device registrants participating in the pilot, 2 operating companies, and 3 users. The main purpose of this work is to establish a system framework. Build a unique identification system for medical devices, covering the functions of creating and endowing unique identification of medical devices, and uploading, downloading, and sharing data, building a unique data platform for medical devices in Tianjin, and achieving an effective connection with the medical device unique identification database of the State Drug Administration And the basic construction of medical materials big data platform. The second is to expand the application of the system. Carry out the pilot application of the unique logo in the production, operation and use of medical devices, and explore the application of the unique logo in the reports of medical device adverse events and product recalls. The third is to build a traceability system. Explore the establishment of a traceability management system for the full life cycle of medical devices covering all aspects of production, operation, use, etc., conduct scientific research on the standardization system of traceability of medical device products, and use the research results as policies, division of responsibilities, platform construction, schedules, etc. Important reference basis for implementation. The fourth is docking medical management. Explore the application of the unique identification of medical devices in health care, medical insurance and other fields, and form a mapping with the national medical insurance high-value medical consumables code, so that the medical device unique identification system can be connected with the high-value medical consumables procurement and medical insurance payment review platform, and establish joint participation , A benign mechanism for co-creating value and sharing results, to achieve data sharing of information platforms such as medical device review and approval, clinical application, daily supervision, medical insurance settlement and other information platforms.
According to the schedule of the "Plan", Tianjin will complete the uploading of the first batch of registrant pilot units before the end of June, and continue to promote the construction and use of the UDI system in conjunction with the actual application of Tianjin, and explore the establishment of medical services based on UDI The full life cycle traceability platform for device products guarantees the safety of public equipment in Tianjin. (Finish)