Due to its relatively low price and endorsement by celebrities and influencers, Zenyum’s invisible braces from Singapore have been highly discussed in recent years, and many consumers choose this brand of invisible braces.
Members of the Self-Help Association held a press conference on the morning of the 24th. Many consumers complained that their teeth were permanently damaged after using this invisible braces. Some people had their front teeth corrected, but after correction, they actually had a gap between their front teeth, their bite became an empty bite, and finally their gums atrophied and their teeth changed color.
The Self-Help Association believes that the operator has confused the public through the difference in the meaning of the license, and is suspected of illegal imports. It will sue the manufacturer for tens of millions of yuan. If any internet celebrities or entertainment stars who endorse products do not remove their endorsement videos, the Self-Help Association will investigate them to the end.
Huang Weilin, a lawyer at the Self-Help Association, pointed out that the Ministry of Health and Welfare only approved the import of raw materials by Zenyum, but the company directly manufactured the finished invisible braces in China and imported them directly into Taiwan with a license, using low costs and price competition. In addition to being suspected of software changes, the company was also involved in violating relevant medical regulations, because the correction of front teeth should be performed by domestic dentists or dental technicians, but the Zenyum invisible braces were actually handed over to an unknown person in China.
Zenyum also issued a statement on the same day, saying that since entering the Taiwanese market in 2020, it has always operated in accordance with the law and applied for a medical device license from the Food and Drug Administration. All imports and company operations are in compliance with regulations and there is absolutely no violation of the law. Anyone can verify through the Food and Drug Administration’s “Medical Device License Inquiry” system. The license clearly states the product’s appearance, place of manufacture, and factory, ensuring that the product’s source is transparent and in compliance with regulations.
The company emphasized that its products are customized medical devices that are imported into Taiwan in accordance with the law and can be used legally without being processed and manufactured by domestic dental technicians. After years of operation, the competent authorities and customs have never accused our company’s products of illegal imports, which fully proves its legality.
Qian Jiahong, director of the Medical Equipment and Cosmetics Division of the Food and Drug Administration, said that after checking the “Youya” transparent orthodontic braces system (Ministry of Health Medical Equipment Import No. 001486) license, the scope of approval is orthodontic dental mold sampling, orthodontic design software and braces materials; in practice, dentists only need to use the licensed software to plan orthodontic treatment plans for specific patients, and based on the treatment plan, the transparent orthodontic braces produced by the licensed manufacturer are customized equipment, which is the output of medical personnel performing statutory business and belongs to the medical business link. The import of the braces does not need to apply for inspection and registration or registration with the central competent authority. Other denture products currently have similar services in the country.
The FDA stated that if dentists use domestically approved software and entrust qualified businesses to make braces, it is a legal customized medical device. However, since there are reports from the public, the FDA will ask the Health Bureau to assist in investigating and clarifying the suspected violations of product supply sources and advertising revealed at the press conference and handle them according to the law.
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