The Food and Drug Administration (FDA) yesterday warned members of the public that cotton swabs can be categorized as “medical use” and “non-medical use,” and purchasing excessive amounts of medical use cotton swabs from abroad is illegal.
A woman in Tainan was recently fined for buying more than 200 medical use cotton swabs from Chinese e-commerce platform Taobao, an action that allegedly contravened the Medical Devices Act (醫療器材管理法), which stipulates that for the manufacture or import of medical devices, people must file an application to the central competent authority for registration and market approval, or else they could face up to three years imprisonment or a fine up to NT$10 million (US$326,958).
As the woman did not comply when she was summoned for questioning, she was detained, the Tainan District Prosecutors’ Office said.
Photo: Taipei Times
Regular cotton swabs used for removing makeup, cleaning or other uses are categorized as “general goods” and are not regulated by the act, FDA Medical Devices and Cosmetics Division Director Chien Chia-hung (錢嘉宏) said.
People are allowed to bring up to 200 medical use cotton swabs into Taiwan from overseas every six months, but to bring more, they need to file an application and pay import fees, or the products may be disposed of, or returned, and the person may face punishment, the act states.
If people bring in non-medical use cotton swabs from abroad, they must comply with customs regulations, and if they want to import excessive amounts, they might face customs duties, but it is not related to the Medical Devices Act, Chien said, adding that customs officers may ask for FDA assistance when they cannot identify whether a product is a medical device.
Only some types of medical devices can be sold online, and only by retailers that have required licenses, and the product name and permit number must be shown on the Web page, he said.
Asked why the woman in Tainan was fined NT$100,000, he cited prosecutors as saying that the fine was not because she violated the act, but because she refused to appear when summoned for questioning.
The case is still being investigated by prosecutors, and the court has not made a final ruling, so the details are unknown, he added.
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