Tianjin launches pilot work of unique identification system for medical devices
Published:
2020-05-28
Source:
医药网
Author:
Pharmaceutical Net, May 28th, Tianjin Drug Administration, Tianjin Medical Security Bureau and Tianjin Municipal Health Commission jointly issued the "Tianjin Municipal Medical Device Unique Identification System Pilot Work Plan", aiming to promote the unique medical device identification system in Tianjin according to law. The implementation of the rules of the labeling system will improve the efficiency of medical device supervision and health management, standardize medical service behavior, strengthen the material control capabilities of medical protective medical devices and other products required for the prevention and control of the new crown pneumonia epidemic, and effectively ensure the safety of public use of devices.
In accordance with the unified deployment of the "Pilot Work Plan for the Unique Identification System for Medical Devices" jointly issued by the State Drug Administration and the National Health Commission, combined with the State Drug Administration's "Notice on Doing a Good Job in the First Batch of Implementing the Work of Unique Identification for Medical Devices" ”, Tianjin Food and Drug Administration innovatively proposed a pilot operation mode of the unique identification (UDI) system for medical devices around the “three medical linkages”. On the basis of many previous meetings, visits and investigations, organization of training and other work, organized enterprises to carry out coding work, combined with the use of anti-epidemic materials used in the new crown pneumonia epidemic, worked with Tianjin Municipal Medical Insurance Bureau and Tianjin Municipal Health and Health Commission to formulate the "Plan" ".
It is understood that the first batch of 16 medical device registrants, 2 operating companies and 3 user units participated in the pilot program. The main purpose of this work is to establish a system framework. Build a unique identification system for medical devices, covering the creation and assignment of medical device unique identification, as well as data upload, download and sharing functions, build a unique identification data platform for medical devices in Tianjin, and achieve effective docking with the medical device unique identification database of the State Drug Administration and the basic construction of a big data platform for medical supplies. The second is to expand the application of the system. Carry out pilot applications of unique identifiers in the production, operation, and use of medical devices, and explore the application of unique identifiers in medical device adverse event reporting, product recalls, and other aspects. The third is to build a traceability system. Explore the establishment of a traceability management system covering the entire life cycle of medical devices covering production, operation, use, etc., conduct scientific research on the standardization system of medical device product traceability, and use the research results as policies, division of responsibilities, platform construction, and schedule arrangements. important reference for implementation. Fourth, docking medical management. Explore the application of medical device unique identification 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 and high-value medical consumables procurement and medical insurance payment review platform to complete the docking, establish joint participation , a benign mechanism for co-creating value and sharing results, and realizing data sharing of information platforms such as medical device review and approval, clinical application, daily supervision, and medical insurance settlement.
According to the schedule of the "Plan", Tianjin will complete the code assignment and upload of the first batch of registrant pilot units by the end of June, and continue to promote the construction and use of the UDI system in combination with the actual application in Tianjin, and explore the establishment of UDI-based medical services. The full life cycle traceability platform of equipment products ensures the safety of public equipment in Tianjin.
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