Liaoning Provincial Drug Administration
Current Location: 首页 >> Work dynamics

The provincial Food and Drug Administration organized the third quarter medical device operation and use link safety risk meeting

10月19日,The provincial Food and Drug Administration held a safety risk meeting in the third quarter of 2023 for the operation and use of medical devices,Organize the municipal and Shenfu Demonstration zone market supervision bureau to discuss and analyze the risks and hidden dangers in the operation and use of medical devices,Arrangements were made to strengthen the risk investigation and rectification work。

会上,Each city and Shenfu Demonstration Zone market supervision Bureau exchanged speeches on the investigation and resolution of risks and hidden dangers in the operation and use of medical devices in the third quarter of the jurisdiction,The discussion focused on the implementation of the risk consultation principle of "step by step risk consultation and supervise the implementation at every level", strengthening the daily supervision work, promoting the special rectification of the quality and safety of medical devices, and the risk points and solutions existing in the operation and use links。

Meeting requirement,All localities should further do a good job in identifying hidden risks,Really find out what's going on,Identify risk,Establish a risk list responsibility system and a number cancellation system,Formulate effective measures,Ensure early detection, disposal and cancellation of risks and hidden dangers;It is necessary to strengthen the publicity and training of the Regulations on the Supervision and Administration of Medical Devices and supporting rules and regulations,Urge enterprises to carefully compare the requirements of the Provisions on the Supervision and Management of the Main Responsibility for the implementation of Medical Device Quality and Safety by Enterprises,Full self-examination and self-correction,Promote enterprises to fulfill their main responsibilities;It is necessary to carry out special rectification work on the quality and safety of medical devices,Ensure that the priorities identified in the programme are delivered in high quality;Dare to fight hard,Violations of laws and regulations discovered during supervision and inspection shall be strictly investigated and punished in accordance with the law and publicly exposed,Urge enterprises to effectively improve the sense of responsibility, quality awareness。

This risk meeting analyzed and judged the disposal situation of 15 risk points identified in the first two quarters, and 14 risk closed loops have been completed after assessment。At the same time, the risk points of the operation and use of medical devices in the third quarter were analyzed and judged, and 5 risk points were sorted out, and preventive measures were formulated one by one。