Linfen Market Supervision and Administration Bureau Organizational Medical Devices Adverse Equipment Monitoring Business Training Business Training

In order to further strengthen the daily monitoring of bad incidents in the city's medical device, strengthen the discovery, identification, evaluation and quality risk research and judgment of the risk signal of medical device, and in accordance with the work arrangements of the National Medical Device Safety Publicity Week, the Linfen Market Supervision and Administration Bureau organized a period of 2 The city's medical device adverse event monitoring business training, follow the impact of the impact of adverse events in medical device after the implementation of the Regulations on the Supervision and Administration of Medical Device and the development of the next monitoring work. Deputy county -level cadre Wang Hong attended and spoke, and Fan Huoping, deputy director of the Municipal Comprehensive Inspection and Testing Center, attended.

Wang Hong requested that law enforcement officers and relevant personnel of participating enterprises in the city (city, district) municipal supervision bureaus (branch bureau) in the city should strictly implement the requirements of the monitoring of adverse events in medical device, and report suspiciously, that is, reportedly reported, and reported it. The sense of responsibility and the overall situation, work solidly, support the security barrier for the public with weapons, and make new contributions to the healthy and rapid development of the city's medical device industry.

During the training, the Municipal Pharmaceutical Adverse Reaction Monitoring Center introduced the overall situation and work progress of bad events monitoring in the city in the first half of the year, and put forward rectification measures for the lack and problems in the work, and pointed out the direction of the work in the second half of the year. Fan Huoping emphasized and explained the important role of medical device monitoring in the supervision of medical device and quality risk prevention and control, and summarized the quality management found in the investigation of hidden dangers of medical device risk in the first half of the year.

Training hired well -known experts in the province to preach laws and regulations such as the "Regulations on the Supervision and Administration of Medical Devices" and "Monitoring and Repentance Management Measures for Medical Device Adverse Evaluation and Re -Evaluation and Management". The significance, legal basis, report filling, precautions, and common issues, etc., highlight the significance and value of the monitoring of adverse events, and ensure reasonable and safe use of equipment. At the same time, combined with case analysis The importance and necessity, the basis of regulations, the filling of the content specifications of the monitoring report, the timeliness of the report, etc., and urge medical institutions to actively collect and report to the adverse incidents of medical devices, especially bad medical devices.

In the next step, the Linfen Market Supervision and Administration Bureau will adhere to the basic principles of "monitoring, scientific evaluation, and timely warning in accordance with the law" to implement the responsibility Safety monitoring work, ensure the quality of monitoring data from the source, effectively give full play to the early warning role of the monitoring of bad events in medical device, ensure the safety of public equipment, and achieve new progress in monitoring of bad events in the city.

Municipal Comprehensive Inspection and Testing Center cooperates with organizational training related work; leaders and technical personnel in charge of adverse events in the medical device of the city (city, district) municipal supervision bureaus in the city, leadership and technical personnel in the test of bad events of medical device adverse events above the second level or above, Some township health centers monitors and medical device registered persons (recorders) are in charge of leaders and technicians in charge of bad events.

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