Strengthen the quality sampling of crown support products

according to the website of the State Drug Administration, the State Drug Administration recently issued a "notice on strengthening the quality supervision of the selected crown stent in the procurement of centralized belt volume" (hereinafter referred to as "Notice"). "Notice" clearly, the provincial drug regulatory departments to strengthen the quality of the crown brace product sampling work, according to the problems found in the daily supervision, the production, circulation, use of samples to carry out quality inspection of key projects. For the selected enterprises should be combined with the production enterprise on-site inspection, should be at least once a year."Notice" said that recently, the State Health Insurance Administration and relevant departments to organize the coronary bracket centralized belt procurement work. The provincial drug regulatory departments should fully understand the importance of this centralized procurement work, always adhere to the people's health as the center, fully implement the "four most stringent" requirements for drug safety, promote enterprises to implement the main responsibility, strictly implement the responsibility of local supervision, and effectively ensure the quality and safety of centralized procurement crown bracket. The relevant work requirements are as follows:is to fully implement the main responsibility of enterprise quality and safety. Crown bracket production enterprises should firmly establish the sense of responsibility of the main body of quality, strictly in accordance with the requirements of production quality management norms, improve the quality management system and maintain effective operation, to ensure that the factory products meet the quality requirements. The selected enterprises should strictly audit raw materials and supplier management, carefully check the risks and hidden dangers of the production process, effectively strengthen the control of the production process, quality control and release of finished products, and take effective measures to ensure that product quality meets mandatory standards and registered product technical requirements.In accordance with the "National Drug Administration, National Health And Health Commission, National Health Insurance Bureau on in-depth promotion of the pilot to do a good job in the first batch of the implementation of the unique identification of medical devices announcement " No. 106 of 2020) to do a good job of product identification, establish and improve the traceability system of crown support products, and effectively do a good job of product recall, tracking and tracing related work.Second, we should effectively strengthen supervision and inspection of the production links. Provincial drug regulatory departments should adhere to the problem-oriented, strengthen the daily supervision of crown stent production enterprises, and urge enterprises to implement the main responsibility. The provincial drug regulatory department where the selected enterprise is located shall step up the on-site inspection of the enterprise, organize lean professional forces to supervise and inspect the whole project of the selected enterprise at least once a year, and report the inspection to the Equipment Supervision Department of the State Drug Administration at the end of each year. The most recent inspection should be completed by the end of 2020.Key inspection: whether the production and inspection personnel have been trained appropriate to the post, and have the corresponding knowledge and skills, bracket platform materials, coating polymers, drugs and other key raw materials have changed, acid wash polishing, drug coating coating, sterilization and other key processes / special processes are consistent with verification / confirmation;Third, do a solid job in circulation and use of the link supervision and inspection. The provincial drug regulatory departments urge and guide the departments responsible for drug supervision in each city and county to effectively strengthen the supervision of circulation and use links, urge the distribution units of the selected crown support products to strictly implement the requirements of the medical device management quality management standards, and take effective measures to ensure that the transportation and storage process of the selected crown stent products conforms to the product description. Book or label marking requirements, and do a good job of transportation, storage of the corresponding records, urge medical institutions in strict accordance with the "medical device use quality supervision and management measures" requirements, do a good job in the procurement, acceptance and storage of medical equipment quality management, to ensure that the selected crown vein support products in circulation and use of the quality safety and traceability.Fourth, seriously carry out the quality sampling of selected varieties. The provincial drug regulatory departments should strengthen the quality sampling of crown brace products, and carry out quality inspection of key projects in the production, circulation and use of samples according to the problems found in daily supervision. For the selected enterprises should be combined with the production enterprise on-site inspection, should be at least once a year. Unqualified products found shall be seriously investigated and dealt with in accordance with the law, quality announcements shall be issued, and the medical insurance departments and health administrative departments at the same level shall be notified.The relevant medical device inspection institutions shall give priority to the provincial drug regulatory departments to entrust the examination of the products of the selected crown vein support, arrange the inspection and issue a report in a timely manner. The provincial drug regulatory department where the selected enterprise is located shall report to the Equipment Supervision Department of the State Drug Administration in the first quarter of the following year the quality sampling of the products of the annual crown stent and the results of disposal. The State Drug Administration will organize special sampling of selected products.Fifth, we will continue to strengthen the monitoring of adverse events. The provincial drug regulatory departments should strengthen the monitoring of adverse events of crown brace products, urge the selected enterprises to implement the main responsibility for the monitoring of adverse events in accordance with the Measures for the Monitoring and Re-evaluation of Adverse Events in Medical Devices (State Administration of Market Supervision, Order No. 1 of the State Health and Health Commission), establish a sound monitoring system for adverse events, promptly detect, investigate and evaluate suspicious adverse events, and report regular risk assessment reports on time. Monitoring technical institutions to monitor the abnormal risk signals, aggregate signals should be timely organization of investigation and disposal, and report to the corresponding regulatory authorities.Sixth, strengthen departmental coordination and information communication. Provincial drug regulatory departments should attach great importance to the centralized procurement of high-value consumables related products and enterprise quality supervision work, strengthen coordination and coordination with health, medical security and other departments, and effectively ensure the safety and effectiveness of selected medical devices. The provincial drug regulatory department where the selected enterprise is located shall urge the enterprise to implement the responsibility of product supply guarantee, strictly implement the relevant regulatory requirements of the shutdown report, grasp the production and marketing situation of the selected varieties of the enterprise in a timely manner, and jointly promote the smooth and orderly progress of the procurement work with volume. We should establish and improve the emergency disposal mechanism for the quality of crown braces, properly deal with hot issues, open the channels for reporting complaints, and promptly investigate and punish violations of law and discipline.The Notice states that the provincial drug regulatory departments should report to the State Drug Administration in a timely manner if they encounter major problems in their regulatory work, and that the State Drug Administration will conduct supervision and inspection of the work of the provincial drug regulatory departments in due course. (China News Network)