China News Service, August 30. 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" (hereinafter referred to as the "Notice"), and decided to start from September 2022. From the 1st, a 3-month special campaign to standardize the production and operation of decorative colored contact lenses will be organized nationwide.
According to the "Notice", the work goal of this special action is to severely crack down on the production and operation of unregistered decorative color contact lenses, illegal online sales, no medical device production and operation qualifications, and out-of-scope operations. Cases, punish offenders, expose typical cases, eliminate hidden quality and safety risks, establish and improve mechanisms, and form a standardized and orderly market order.
The "Notice" deploys four tasks: standardizing the production of decorative color contact lenses, regulating the business behavior of decorative color contact lenses, regulating the behavior of online sales of decorative color contact lenses, and severely investigating and punishing various violations of laws and regulations in accordance with the law. The content of key supervision and inspection of drug regulatory authorities at all levels has been formulated.
For example, in regulating production behaviors, provincial drug regulatory authorities should focus on checking whether production enterprises organize production in accordance with mandatory standards and registered product technical requirements, whether raw material procurement and supplier management meet the requirements, etc.; in regulating business behaviors, The drug regulatory department should focus on checking whether the operating enterprises operate decorative color contact lenses without a registration certificate, whether they operate decorative color contact lenses without a license, and whether they operate beyond the scope of operation; for online sales, the drug regulatory department should focus on inspecting medical devices. Whether the third-party platform for online trading services strictly fulfills the legal obligations of qualification information review, commodity information monitoring, and handling of violations, whether online sales companies display production and business licenses and product registration certificates as required, and whether relevant information published online content remains the same.
The "Notice" requires that drug regulatory departments at all levels should strengthen organizational leadership, formulate supervision and inspection work plans based on actual conditions, decompose and refine objectives and tasks, and promote implementation in accordance with the schedule; research and innovative supervision methods and methods should be formed to form a long-term supervision mechanism. , strengthen coordinated supervision and joint punishment with the Internet, public security, health, customs and market supervision and other departments to jointly crack down on violations of laws and regulations; to strengthen publicity and guidance, and popularize knowledge about decorative colored contact lenses.
The State Food and Drug Administration will organize an inspection team in a timely manner to supervise and inspect the supervision and inspection work in various places.
(Zhongxin Finance)
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