Reporting reports on the quality supervision of medical device selected in concentrated with volume

On July 12, the State Drug Administration held a report meeting for the quality supervision of medical device quality in centralized band purchases. In the two coronary brackets and 4 arthropate collection, companies selected enterprises to report the operation of the selection of products, the operation of the enterprise quality management system, and the guarantee of product quality measures. Report work. Xu Jing, a member of the Party Group and Deputy Director of the State Drug Administration, attended the meeting and delivered a speech.

The meeting pointed out that in recent years, the procurement of centralized and band procurement of medical devices has been accelerated. "Notice", "Strengthening the Working Plan for the Supervision of Medical Device Quality Supervision in the Purchase of centralized bands", and comprehensively strengthen the implementation of the responsibility of enterprise subjects and the implementation of local regulatory responsibilities. From the perspective of supervision, inspection, supervision and random inspection, etc., the quality and safety status of medical equipment selected in the collection is good, and the results of the spot checks are qualified.

The meeting emphasized that the concentrated volume of medical equipment has a wide range of coverage, there are many types and specifications, and the number of clinical use is large. The selection of enterprises and drug supervision departments at all levels must strengthen the awareness of responsibility. Risk is highly alert.

The meeting requested that the selection of enterprises and regulators in each episode should further enhance the sense of responsibility and mission, thoroughly implement the "four most stringent" requirements, adhere to the bottom line of thinking, strengthen the awareness of risk, and do their best Essence All relevant enterprises must conscientiously fulfill their political responsibility, legal responsibility and social responsibilities, the example rate of the system of legal regulations, the examples of the implementation of the regulatory system, the example of the continuous compliance of the system, and the appearance rate of quality and cultural construction, implement the main responsibility of the enterprise, ensure the quality and safety of the product and safety of the product Essence Drug supervision departments at all levels should strengthen risk investigation, strengthen illegal investigation and punishment, strengthen departmental coordination, strengthen guidance services, implement territorial supervision responsibilities, and ensure that regulatory services are in place.

The meeting was held in a video.国家药监局器械监管司、中检院、核查中心、评价中心、受理和举报中心、信息中心有关负责人和工作人员，北京、天津、吉林、上海、江苏、安徽、福建、江西、山东、 Guangdong, Guangxi, Hainan, Yunnan, Ningxia and other 14 provinces (autonomous regions, municipalities) drug supervision bureaus, heads and staff of the relevant offices and staff of the instrumental supervision of equipment attended the meeting.

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