Gangshan Branch of Zuoying Armed Forces General Hospital

With the summer season approaching, the Taiwan Food and Drug Administration (TFDA) reminds you to check whether products purchased abroad are classified as medical devices and to comply with relevant import regulations, so that unexpected hassles won’t ruin your vacation.

According to Article 6, Paragraph 4 of the Regulations Governing Special Approval for Manufacture or Import of Specific Medical Devices, travelers may bring medical devices into Taiwan without applying for special approval from the TFDA, provided that the items are for personal use and do not exceed the quantity limits listed below. Eligible products may be processed through facilitated customs procedures. Importation of each category is limited to once every 6 months.

The permitted items and quantity limits are as follows:

• Adhesive bandage: No more than 60 pieces in total.
• Liquid bandage: No more than 4 tubes (jars, bottles, units) in total.
• Cotton swabs: No more than 200 pieces in total.
• Condoms: No more than 60 pieces in total.
• Tampons: No more than 120 tampons in total.
• Daily disposable contact lens: 60 pieces for the same diopter; each person is limited to one brand and two different diopters.
• Corrective lenses: No more than 1 pair.
• Medical mask: No more than 250 pieces in total.

The TFDA emphasizes that medical devices imported under these provisions are for personal use. They may not be sold, transferred, or provided to any other party. A common violation involves selling unused medical devices through online platforms. Such conduct may constitute a violation of the Medical Devices Act. Violators may be subject to administrative fines ranging from NT$30,000 to NT$ 1,000,000.

The TFDA regulates medical devices throughout their entire product lifecycle, including pre-market review, post-market surveillance, and quality system inspections of manufacturers, to help ensure the safety and effectiveness of medical devices. Although facilitated customs provides convenience for travelers, individuals remain responsible for the safety and performance of any medical devices they personally bring into Taiwan or import from overseas by mail. In addition, overseas-purchased products may not be covered by domestic after-sales services or consumer protection.

The TFDA recommends that consumers purchase medical devices approved or registered in Taiwan. Information on approved medical devices is available in the Medical Device License Database on the TFDA website.

Data URL link：https://www.fda.gov.tw/ENG/newsContent.aspx?id=31577