Today, 200 people formed a self-help group to accuse Zenyum of causing problems after wearing the famous “invisible braces” and questioned the company for illegally importing finished braces. In response, Zenyum responded that all imports and company operations are in compliance with regulations and there is absolutely no violation of the law. The Food and Drug Administration stated that as long as dentists import customized braces through a licensed system or manufacturer, it is a legal process and does not require an inspection registration or registration. In response to public reports, the Department of Health will be asked to help clarify.
Zenyum invisible braces come from Singapore. The main price is cheaper than traditional tooth correction. In addition, many celebrities and Internet celebrities have endorsed it, so many people in the country have chosen to use this braces. However, today 200 people formed a self-help group, accusing the manufacturer of problems after using braces, and even sued the manufacturer for compensation.
In response, Zenyum responded that since entering the Taiwan 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 appearance, place of manufacture, and manufacturer information to ensure that the product source is transparent and in compliance with regulations.
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 impression sampling, orthodontic design software and braces materials; and in terms of operation, dentists only need to use the licensed software to plan orthodontic treatment plans for specific patients, and use the treatment plan to ask the licensed manufacturer to produce transparent orthodontic braces. The finished products are customized equipment, which are the output of medical personnel performing statutory business and belong 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.
Qian Jiahong emphasized that, however, since there have been reports from the public, the FDA will ask the Bureau of Health to assist in investigating and clarifying the suspected violations related to product supply sources and advertisements revealed by the press conference.
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