The State Food and Drug Administration comprehensively strengthened the supervision of medical masks. The quality of medical masks continued to be good

On December 7, the State Administration for Market Regulation held a regular press conference for the fourth quarter with the theme of "Strengthening the quality supervision of masks, ensuring people's health and safety, and serving the overall situation of epidemic prevention and control". At the meeting, the head of the device supervision department of the State Food and Drug Administration said that the State Food and Drug Administration thoroughly implemented the relevant requirements of the Party Central Committee and The State Council on the supervision of medical devices for epidemic prevention and control, performed their duties in accordance with the law, strictly supervised, and included the supervision of medical masks in the annual key work. Comprehensively strengthen the supervision of medical masks, comprehensively carry out risk and hidden dangers investigation, comprehensively strengthen the quality sampling of medical masks, accurately carry out flight inspection of medical masks, vigorously strengthen quality and safety supervision, and assist relevant departments to ensure supply.

Since the beginning of this year, the State Food and Drug Administration has comprehensively strengthened the supervision of medical masks. In February, the State Administration of Market Regulation, the Ministry of Industry and Information Technology, the State-owned Assets Supervision and Administration Commission and the State Food and Drug Administration jointly issued the "In-depth promotion of mask quality supervision to promote the quality of masks to improve the special rectification action plan", requiring a comprehensive investigation of risks, strengthen the quality supervision of medical masks and other products, strengthen the treatment of unqualified products, highlight the quality supervision of online sales, and severely crack down on all kinds of illegal behavior. In March, the State Food and Drug Administration issued the Notice on carrying out the Investigation and Management of Hidden Risks of Medical Device Quality and Safety, which clearly took the epidemic prevention and control medical devices, including medical masks, as the first investigation and rectification focus, requiring all places to conduct comprehensive investigation of hidden risks, fully implement governance responsibilities, comprehensively improve management level, and comprehensively strengthen quality assurance. By the end of October, the provincial drug administration had investigated 8304 medical device manufacturers for epidemic prevention and control in the investigation and management of medical device risks, dispatched 22,400 people to inspect, supervised and inspected 8674 times, ordered 145 to stop production, and filed 299 penalties.

In addition, the State Food and Drug Administration strengthened special sampling of epidemic prevention medical devices, sampling 153 batches of medical masks. The provincial drug administration has formulated a provincial sampling inspection plan, focusing on the quality of medical devices such as medical masks for epidemic prevention and control, so that they should be pumped out. At the same time, it has increased flight inspection efforts, insisted on problem-oriented, strengthened targeted and precise supervision, and always listed medical masks and other medical devices for epidemic prevention and control as key varieties for flight inspection, and the provincial drug administration also listed medical masks as key varieties. Organize and carry out provincial-level flight inspection. On the whole, the quality of medical masks in China continues to be good.

In the next step, the State Food and Drug Administration will increase the publicity and implementation of the newly revised Regulations on the Supervision and Administration of Medical Devices, strengthen the training of "key minorities" such as legal representatives of medical device manufacturers such as medical masks for epidemic prevention and control, strengthen the awareness of the rule of law, responsibility, risk awareness, compliance awareness and self-discipline awareness of enterprises, and continue to strengthen the construction of quality management system. Further enhance the enterprise risk prevention and control capabilities; Strengthen the investigation and resolution of risks and hidden dangers, guide and urge provincial drug supervision and administration departments to rectify emerging and tendency problems, strictly implement the requirements of "punishment to people" for illegal behaviors, and urge enterprises to produce and operate according to law; Continue to include medical masks and other medical devices for epidemic prevention and control in the key varieties of flight inspection, through the organization of flight inspection, urge relevant provincial drug supervision and administration departments to continue to do a good job in the supervision of medical devices for epidemic prevention and control, urge manufacturers to continuously improve product quality and safety management level, and effectively ensure the quality and safety of medical devices for epidemic prevention and control.