According to the State Food and Drug Administration's "Tips for Purchasing and Using Decorative Colored Plain Contact Lenses", decorative colored plain contact lenses are contact lenses used to decorate and change the color of the cornea. Because it directly covers the surface of the cornea and is in close contact with eye tissue, it is directly related to the safety of the human eye and has a relatively high risk. It is managed as a third-class medical device in China and needs to pass safety and effectiveness evaluations before it goes on the market. The device can be produced, sold, and used only after the device registration certificate, and its manufacturer needs to obtain the "Medical Device Production License". Enterprises operating such products need to obtain a "Medical Device Operation License".
