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Health

SFDA: strictly prevent and control the quality and safety risks of color contact lenses

2022-09-08   

On September 7, the State Food and Drug Administration held a video conference on the special rectification of the production and operation of color contact lenses, requiring drug regulatory departments at all levels to strictly prevent and control the quality and safety risks of color contact lenses. The meeting pointed out that since the color flat contact lenses were included in the scope of medical device supervision in 2012, the drug regulatory authorities have deployed and carried out a series of special actions to continuously strengthen the supervision and inspection of color contact lenses. On August 30, the State Food and Drug Administration issued the notice on carrying out special rectification actions to standardize the production and operation of decorative color contact lenses, deciding to organize and carry out a three-month special rectification action to standardize the production and operation of color contact lenses nationwide, further standardize the production and operation of color contact lenses, and ensure the safety of consumers' equipment. Xu Jinghe, member of the leading Party group and deputy director of the State Food and drug administration, stressed that color contact lenses belong to the third category of medical devices with high risks. According to the regulations on the supervision and administration of medical devices, they are products that need to be strictly controlled and managed by special measures. Their quality and safety directly affect the visual health of consumers. Xu Jinghe demanded that drug regulatory departments at all levels should grasp the key points of their work, strictly prevent and control the quality and safety risks of color contact lenses, and ensure the quality and safety of products in the whole life cycle. First, we must severely punish those who violate laws and regulations. We will persist in investigating and dealing with offline violations and online violations, promote the punishment of violating units and individuals, strengthen the connection of execution, and promptly transfer suspected crimes to public security organs. Second, we should strictly standardize production and operation. Standardize R & D, production and operation behavior, standardize Internet information services, standardize the management of third-party platforms for online trading services, and consolidate the main responsibility of enterprises. Third, we should strictly implement supervision responsibilities. We will improve the list of supervision objects, comprehensively investigate potential risks, strengthen work supervision and inspection, pay attention to coordinated supervision between departments, and cultivate typical examples. Fourth, we should promote social governance in a down-to-earth manner. Timely publish the information of approved products, publish the list of registrants and manufacturers, unblock the channels of complaints and reports, implement the reward policy for reports, and publicize and popularize relevant knowledge. Fifth, strengthen the building of regulatory capacity. Drug regulatory departments at all levels should pay close attention to ability training, keep pace with the times, and improve the professional ability of regulatory personnel. (outlook new era)

Edit:qihang Responsible editor:xinglan

Source:People.cn

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