Recently, in the special action carried out by the food and drug inspection in Shandong Province, a special rectification was carried out for the “Mei”. This morning, Liu Bengong, director of the Medical Device Supervision Department of the Shandong Food and Drug Administration, said that in China, the United States is the third-class medical device with the highest risk category. When purchasing a beauty product, consumers should purchase it from a medical device business enterprise that has the relevant business license qualification, and confirm that the purchased product has obtained the medical device registration certificate. Do not buy cheaply from non-formal merchants or online shops. Registered product.

Decorative color flat contact lenses, which are commonly known as "beauty", are the key products of the special action of the provincial food supervision in the past two years. “Mei” is a registered trademark of a company's decorative color flat contact lenses. Because the company's products entered the Chinese market earlier, everyone is accustomed to use Meilu as a synonym for “decorative color flat contact lenses”.

Liu Bengong said that because Meilu is a product directly in contact with the cornea, it is managed in China by the third category of medical devices with the highest risk category. The use of Meilu products is large, but the operators are mostly vendors and beauty shops. The phenomenon of unlicensed operation or operation of unlicensed products is more common. The purpose of special rectification is to crack down on unlicensed operations, operate unlicensed products and out-of-scope operations, and investigate and deal with counterfeit and shoddy products. The county-level food and drug supervision department is required to inspect the business premises such as the optical shopping mall, optical shops, medical equipment management enterprises, school peripheral jewelry stores, and small commodity wholesale markets within its jurisdiction.

In the special rectification supervision and inspection, the provincial food and drug supervision found that the general awareness of laws and regulations of the operators was weak, and the implementation of the quality management system was not strict. The enterprise license, product registration certificate and other information are incomplete, the enterprise purchase inspection system is not in place, the purchase and sale records are incomplete, and some even do not know that decorative color flat contact lenses belong to the third category of medical devices. The sales staff basically do not understand the relevant professional knowledge, nor have they received professional training. They lack the ability to guide consumers to wear correctly, use the care solution correctly, and respond to adverse reactions. Most of the operators are scattered around the school, small commodity city, lattice shop, night market stalls, etc. The operating conditions are low, the area is small, and the concealment is strong. It is difficult for the supervisors to find out that unlicensed operation and operation of unlicensed products have occurred. The punishments (especially fines) imposed by the regulatory authorities on violations of laws and regulations are difficult to implement in place. Due to lower operating costs, most of the operators have left.

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