Selected products of centralized collection such as coronary stents sampled by the State Food and Drug Administration: all qualified

2022-07-13

According to the official website of the State Food and drug administration, on July 12, the State Food and Drug Administration held a report meeting on the quality supervision of selected medical devices for centralized volume procurement. The meeting pointed out that in recent years, the centralized procurement of medical devices has accelerated and expanded. From the work of supervision and inspection, supervision and sampling inspection, the quality and safety of medical devices selected in centralized purchase are in good condition, and the sampling inspection results are qualified. At the meeting, two coronary stents and four artificial joint centralized procurement and selection enterprises reported on the centralized procurement and Selection products, the operation of the enterprise's quality management system and the measures to ensure product quality. The meeting stressed that the centralized procurement of medical devices has a wide coverage, a wide range of types and specifications, and a large number of clinical applications. Enterprises selected in centralized procurement and drug regulatory departments at all levels must strengthen their sense of responsibility, always put prevention and control risks in a prominent position, and always remain highly alert to product quality risks. The centralized procurement of high-value medical consumables is an important decision and deployment of the Party Central Committee and the State Council, and an effective means to deepen the reform of the medical security system and solve the problem of expensive medical treatment for the people. On September 18, 2021, the State Food and Drug Administration issued the work plan for strengthening the quality supervision of selected medical devices in centralized volume procurement, which pointed out that the national medical security department has carried out the centralized volume procurement of coronary stents and artificial joints with relevant departments, and the provincial medical security department has carried out the centralized volume procurement of coronary balloons, intraocular lenses and other varieties. Focusing on the selected varieties of high-value medical consumables purchased by the state in a centralized manner, all provincial drug regulatory departments should bring the selected enterprises into key supervision. For the centralized purchase of selected varieties of high-value medical consumables organized at the provincial level, the provincial drug supervision and administration department where the selected enterprise is located should also earnestly implement the responsibility of territorial supervision, timely and actively collect the selected information of enterprises within its jurisdiction, and bring it into key supervision. (outlook new era)

Edit:Yuanqi Tang    Responsible editor:Xiao Yu

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