The Ministry of Food and Drug Safety said on the 25th that it had identified 108 posts in violation of the Medical Device Act after conducting an online inspection of contact lenses, which are mainly used by young people. The inspection ran from the 10th to the 14th, and the offending posts were requested to be blocked through the Korea Communications Standards Commission and other bodies.
Of the posts identified, 83% were overseas shopping malls operating servers in places such as Japan, Hong Kong, and Singapore. By product type, daily-wear soft lenses accounted for 76%, while extended-wear lenses made up 24%. That means the five-day inspection turned up about 20 violations a day, suggesting there may be many more posts circulating outside the monitoring net.
Colored lenses and daily disposable lenses have become almost essential items among teenagers and people in their 20s. As reviews of wearing them are shared on social networking services and consumption grows as part of appearance management, more consumers have also been turning to cheaper overseas sites with a wider variety of products.
Contact lenses are not cosmetics or general goods; they are medical devices. Because they are products that come into direct contact with the cornea, verification of safety and effectiveness is essential. In principle, direct overseas purchases by consumers of medical devices are prohibited.
The import route is also regulated. Only an importer with an import business license can bring the product into the country after going through approval, certification, or reporting procedures for each product. Selling unapproved overseas lenses online while demanding the buyer’s personal customs clearance number is illegal. That is why posts asking for a customs number are a warning sign in themselves.
A personal customs clearance number is originally used when an individual brings items in for personal use. If a seller asks for that number, it can be seen as a signal that they intend to bypass the formal import process and pass customs under an individual’s name.
Domestic sales rules are even stricter. By law, contact lenses must be sold face-to-face by opticians at optical shops, and online sales themselves are prohibited. If a post selling lenses appears online, whether domestic or foreign, there is a high likelihood that the proper procedures were not followed.
Contact lenses are precision products that must allow oxygen to pass through the cornea. Wearing a product for a long time when its oxygen permeability falls short of standards can damage the cornea.
Colored lenses made with unverified dyes can cause inflammation, and if the prescription power or curvature does not fit the eye, they can strain vision. Eye specialists generally explain that in severe cases, this can lead to keratitis and corneal ulcers.
Even if a problem occurs, there is little recourse. The ministry emphasized that medical devices purchased through overseas direct shipping have not been verified for safety, and that users may have difficulty receiving legal protection in Korea if side effects or damage occur. Even if a refund or compensation is sought, the seller is overseas, making it effectively impossible.
False and exaggerated advertising was also included in the crackdown. Medical devices are subject to penalties under the Medical Device Act if their advertised benefits go beyond approved limits or if they are presented as genuine products without authorization.
It is difficult to blame consumers alone for the situation. Overseas shopping mall lenses are cheap and available in many colors and types. Because online purchase is blocked in Korea, demand has flowed toward foreign sites. Discussions over whether to allow online sales have continued, but the face-to-face sales principle remains in place because of concerns about eye health.
Consumers can check for themselves whether a product is officially approved. By searching the product name on the Ministry of Food and Drug Safety’s Medical Device Safe Shopping site, users can see whether it has been approved, certified, or reported. Making a habit of searching before buying is the easiest safeguard.
The criteria for choosing a seller are simple. It is safer to avoid overseas sites that require a personal customs clearance number and sales posts that offer only the lowest price without an approval number. Since lenses must be selected according to the condition of one’s eyes, the basic approach is to undergo an examination at an optical shop or eye clinic and choose a product that fits one’s eyes.
Even approved products can cause trouble if they are poorly managed. Users should follow the recommended wearing time and avoid sleeping with them on or wearing them while swimming. Using tap water instead of cleaning solution also increases the risk of infection. If the eyes remain red or a foreign-body sensation continues, stop wearing the lenses and visit an eye clinic first.
The ministry is distributing card news materials to inform the public about the risks of overseas direct purchases for products widely used by consumers. It said it will continue inspections of illegal medical-device distribution and provide information on safe use.
There is also criticism that blocking is not the ultimate solution. Overseas sites often reappear after changing their addresses, leading to repeated crackdowns and re-emergence. Some argue that illegal distribution can be reduced only if consumers develop the habit of checking products and if ways to bring demand into the regulated system are discussed together.