The State Drug Administration will carry out the special rectification network sales of "Beauty Pupils" and be included in the focus of investigation

Cover news reporter Shao Meng

On August 30, the State Drug Administration issued the "Notice on the Development of Special Rectification Actions for the Special Rectification of the Production and Operation Behavior of Devitaring and Victor" (referred to as the "Notice"), and decided to carry out three months from September 1st in the country for three months. Standardize the special action of decorative color contact lenses.

Decorative color contact lenses are commonly known as "beautiful pupils". In June of this year, the State Drug Administration issued a prompt "Buy the use of decorative colored flat -light contact lenses (beautiful pupils)", emphasizing that "beautiful pupils" products cover the surface of the cornea and close contact with eye tissue, which is related to human eye safety. It has high risks. As a third type of medical device management in my country, it is necessary to pass safety and effective evaluation before listing. It can be produced, sold and used after obtaining a medical device registration certificate.

The "Notice" emphasizes that the focus of this special operation is to combat production and operation of unregistered decorative color contact lenses, online illegal sales, non -medical device production and operation qualifications, etc., strictly investigate relevant cases, punish illegal elements, and expose typical cases of typical cases. , Eliminate the hidden dangers of quality and safety risks, establish a sound mechanism, and form a standardized and orderly market order.

The "Notice" pointed out that the provincial drug supervision departments should focus on checking whether the production enterprises are produced in accordance with standards and registered product technical requirements, whether raw material procurement and supplier management meet the requirements, and whether key processes and special processes are identified and effectively controlled. Whether the clean room (district) control meets the requirements, whether the process inspection, finished product inspection and finished product release requirements are strictly implemented.

In terms of regulating business behavior, the "Notice" emphasizes that the drug regulatory department shall focus on checking whether the operating enterprise operates the decorative color contact lenses that have not obtained the registration certificate, whether the decorative color contact lenses are operated without a license, whether it is operated by the existing scope, whether there are existence Sell ​​illegal and illegal acts such as fake and inferior decorative color contact lenses and their care products. The glasses mall, glasses shop, residential area, bustling neighborhood, night market, shopping malls, schools around the school, beauty nail shops, small commodity wholesale markets, etc. are organized as a key area to organize pull -ups.

Regarding online sales, the "Notice" requires that third -party platform providers should monitor the sales behavior and information of decorative color contact lenses in the third -party platform. It should be immediately stopped online transaction services, and the relevant records should be preserved to report to the drug supervision department. The pharmaceutical regulatory department shall focus on checking whether the third -party platform strictly fulfills the obligation of qualification information review, product information monitoring, and disposal of illegal behavior. The content of the registration is consistent.

At the same time, the "Notice" states that the drug supervision departments at all levels should strengthen the coordinated supervision and joint punishment of online information, public security, health, customs, and market supervision departments to jointly crack down on violations of laws and regulations. The State Drug Administration will organize the inspection team in a timely manner to supervise and inspect various places.

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