Mon, Feb 03, 2025 page2

• ‘Medical devices’ cannot be resold, the FDA says

  SAFETY RULES: Many medical devices are commonly mistaken to be general goods, including medical cotton swabs, condoms and contact lenses, the FDA said

  • By Lee I-chia / Staff reporter
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  Some products bought in pharmacies, including tampons and adhesive bandages, are listed as “medical devices” in Taiwan and may not be resold, the Food and Drug Administration (FDA) said yesterday.

  Many people did some spring cleaning before the Lunar New Year holiday and might have found unused items, or they might have purchased too many products from pharmacies while traveling abroad during the holiday, but people should determine if the items are considered medical devices before selling them, the FDA said.

  Medical masks, adhesive bandages, gauzes, medical cotton swabs, condoms, tampons, menstrual cups, contact lenses, contact lens cases, contact lens solutions, nasal aspirators and liquid medication dispensers are medical devices commonly mistaken as general goods, it said.

  

  The Food and Drug Administration building in Taipei is pictured in an undated photograph.

  Photo: Chung Li-hua, Taipei Times

  People who do not have a medical device business permit issued by the FDA are not permitted to sell medical device products, whether through online platforms, in physical stores or by delivering the items by hand, the FDA said.

  People who do so might be fined between NT$30,000 and NT$1 million (US$959 and US$31,966) in accordance with the Medical Devices Act (醫療器材管理法).

  The FDA last year said vaginal infections can be more common in the winter, because some women like to wear tight, heavy and less breathable clothing, which could lead to the development of symptoms such as irritation, discharge and itching of the vagina and the vulva.

  Some of those women might turn to intimate cleansing and care products, such as a “therapeutic vaginal douche apparatus” — a device that delivers a stream of liquid (douche solution) into the vaginal cavity for medical or hygienic purposes — but that is also a medical device, so the production and sales of the product require a permit, the agency said.

  The apparatus is mainly used for medical treatment, rather than for daily general hygiene purposes, so people should carefully read the instructions, the FDA added.

  People who independently purchase medical devices should follow three safety rules, it said.

  These are identifying whether the products are medical devices, checking the medical device license number or listing number that is required on the product label, and carefully reading the instructions on how to use them correctly and safely, the agency said.

  People who want to look up a medical device’s permit and its registered information can go to the FDA’s database (https://lmspiq.fda.gov.tw) for confirmation, it added.

  If people develop an adverse reaction after using a medical device, they should report it to the Ministry of Health and Welfare’s National Adverse Drug Reaction Reporting System by calling (02) 2396-0100 or the FDA’s website (https://qms.fda.gov.tw), it added.
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