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The State Food and Drug Administration held a video and telephone conference to strengthen the quality supervision of medical devices for epidemic prevention and control

The State Food and Drug Administration held a video and telephone conference to strengthen the quality supervision of medical devices for epidemic prevention and control

  • Categories:Company News
  • Author:
  • Origin:State Drug Administration
  • Time of issue:2021-07-08
  • Views:0

(Summary description)On July 7, the State Food and Drug Administration held a teleconference on strengthening the quality supervision of medical devices for epidemic prevention and control. The meeting summarized the previous stage of the epidemic prevention and control medical device quality and safety supervision work, analyzed the current supervision work situation, and re-emphasized, re-advanced, and re-implemented the further strengthening of the epidemic prevention and control medical device quality and safety supervision. Xu Jinghe, deputy director of the State Food and Drug Administration, attended the meeting and delivered a speech.

The State Food and Drug Administration held a video and telephone conference to strengthen the quality supervision of medical devices for epidemic prevention and control

(Summary description)On July 7, the State Food and Drug Administration held a teleconference on strengthening the quality supervision of medical devices for epidemic prevention and control. The meeting summarized the previous stage of the epidemic prevention and control medical device quality and safety supervision work, analyzed the current supervision work situation, and re-emphasized, re-advanced, and re-implemented the further strengthening of the epidemic prevention and control medical device quality and safety supervision. Xu Jinghe, deputy director of the State Food and Drug Administration, attended the meeting and delivered a speech.

  • Categories:Company News
  • Author:
  • Origin:State Drug Administration
  • Time of issue:2021-07-08
  • Views:0
Information

  On July 7, the State Food and Drug Administration held a teleconference on strengthening the quality supervision of medical devices for epidemic prevention and control. The meeting summarized the previous stage of the epidemic prevention and control medical device quality and safety supervision work, analyzed the current supervision work situation, and re-emphasized, re-advanced, and re-implemented the further strengthening of the epidemic prevention and control medical device quality and safety supervision. Xu Jinghe, deputy director of the State Food and Drug Administration, attended the meeting and delivered a speech.

  At the meeting, relevant responsible comrades of Tianjin, Jiangsu, Anhui, Jiangxi and Henan Province (municipal) Drug Administrations reported on the quality and safety supervision of medical devices for epidemic prevention and control, summarized and exchanged experience and practices in the supervision of medical devices for epidemic prevention and control, and proposed the next One-step work initiative.

  Since the beginning of this year, local regulatory authorities have been closely monitoring the quality and safety of medical devices for epidemic prevention and control, organizing the investigation and management of hidden risks of epidemic prevention and control medical devices, continuously strengthening supervision and inspection of epidemic prevention and control medical device manufacturers, and focusing on risk Supervised random inspections, steadily promoted the demonstration construction of typical enterprises, and promoted and improved the overall quality and safety level of the industry.

  The meeting emphasized that the regulatory authorities at all levels must conscientiously implement the "four strictest" requirements. Compared with the requirements of the National Drug Regulatory Working Conference and the Medical Device Regulatory Annual Working Conference at the beginning of this year, the supervision of medical devices for epidemic prevention and control under normalization will be the current situation. To further improve the political position, strengthen the sense of responsibility, increase sensitivity, strengthen execution, effectively strengthen organizational leadership, take more effective measures, strictly adhere to the bottom line of quality and safety, and pay close attention to various supervision work to consolidate the important political tasks. The hard-to-find supervision results have made every effort to ensure the quality and safety of medical equipment for epidemic prevention and control.

  Xu Jinghe requested that the regulatory authorities at all levels should follow the requirements for the investigation and management of medical device quality and safety risks deployed at the beginning of the year, make the investigation and management of epidemic prevention and control medical devices the top priority, and carefully check whether various tasks are implemented. First, we must highlight the key points of rectification, strengthen the management of the list of key investigation and governance tasks, focus on enterprises, focus on products, and focus on rectification to carry out risk consultations, and actively play the leading role of excellent model enterprises while cracking down on violations of laws and regulations. Second, we must increase inspection efforts, adhere to problem orientation, list products and companies that have hidden risks such as supervision and inspection, random inspections, etc., as the focus of supervision, implement classified implementation, comprehensive inspection, full inspection, and intensify unannounced inspections to urge enterprises to implement Main responsibility, strengthen system management, and ensure continuous compliance. Third, we must strengthen the effectiveness of random inspections, strictly implement the tasks of random inspections, highlight the targeted nature of random inspections, strengthen risk management, and increase efforts to deal with unqualified products. Fourth, we must persist in the high-hanging sword, increase the investigation and punishment of illegal acts, implement the requirement of "punishing people" for illegal acts, and form a strong deterrent to illegal acts. Intensify the promotion and implementation of new laws and regulations, and further enhance the awareness of the rule of law, responsibility, quality, compliance and self-discipline of enterprises. Fifth, it is necessary to strengthen the coordination and linkage of supervision and form a combined supervision force of source governance, risk prevention and control, information exchange, and coordination and linkage, and further enhance the authority and coordination of supervision.

  Relevant responsible comrades of the Disciplinary Inspection and Supervision Group of the State Administration for Market Regulation, relevant responsible comrades of relevant departments and bureaus of the State Food and Drug Administration and directly affiliated units, the drug regulatory bureaus of various provinces, autonomous regions, and municipalities directly under the Central Government and the Xinjiang Production and Construction Corps Drug Regulatory Bureau in charge of the responsible comrades and the medical device supervision office And staff from related units attended the meeting.

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