Seoul City Conducts Full Investigation of 16 Products Sold on the Market
Five Companies Caught Selling Illegal Chinese Devices
Unfair Profits of 6.6 Billion Won Confirmed... Legal Action Taken
Companies that advertised and sold unauthorized Chinese-made laser devices as if they were effective for treating nail fungus, and gained unfair profits amounting to 6.6 billion won, have been caught.
On July 24, the Seoul Metropolitan Government's Special Judicial Police announced that, after conducting a focused crackdown on 16 types of laser nail fungus treatment devices sold on major online shopping malls, they booked five companies (one manufacturer and four sellers) for illegally manufacturing and selling these devices without approval from the Ministry of Food and Drug Safety.
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In particular, Company A was found to have advertised unauthorized Chinese-made laser devices as if they were effective for treating nail fungus and sold about 29,000 units over two years at 230,000 won each. The unfair profits they gained amounted to 6.6 billion won.
The laser-based nail fungus treatment method was registered as a "new medical technology" by the Ministry of Health and Welfare in 2015, and since the treatment of nail fungus (onychomycosis) is recognized as a non-insured item, it has been widely performed in dermatology clinics in addition to conventional drug treatments.
The companies caught this time manufactured and sold laser nail fungus treatment devices without obtaining approval from the Ministry of Food and Drug Safety, citing cost burdens and other reasons. It was also confirmed that, despite knowing the devices were not effective for treating nail fungus, they illegally advertised and sold them as if they were highly effective.
The city advised that, in order to avoid damage from unauthorized nail fungus treatment devices, consumers should check for the word "medical device" in Korean and verify the "item name and item approval number" on the product. In case of any suspicion, consumers are urged to check on the "Medical Device Safety Information Center" website.
The city especially emphasized the need to be cautious of advertisements that falsely claim effects such as enhanced immunity, improved blood circulation, or cell regeneration, or that mislead consumers into thinking the product is safe for the human body simply because it has obtained the KC Safety Certification Mark, which is used for industrial products.
Kim Hyunjung, Acting Director of the Seoul Metropolitan Government's Special Judicial Police, stated, "Unauthorized and illegal medical devices pose a serious threat to public health, so we will strengthen monitoring of manufacturers and sellers and respond strictly to any illegal activities detected."
If a medical device is manufactured, imported, or sold without approval from the Ministry of Food and Drug Safety, it is a violation of the Medical Devices Act and is punishable by up to five years in prison or a fine of up to 50 million won.
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