Many people might have purchased health-related products during holiday sales to restock home care supplies, but some commonly used products are categorized as medical devices and must be sold with a legal permit, the Food and Drug Administration (FDA) said.
The agency is urging people to only purchase medical-grade masks, bandages, condoms and other medical devices from legal sources, as selling the items without a permit is illegal.
According to FDA data, there were 1,256 cases of medical devices being illegally sold through online platforms last year, lower than the 1,779 cases recorded in the previous year. The majority of them, 1,075, involved selling medical devices without a permit.
Photo: CNA
Through the agency’s promotion and cooperation with e-commerce platforms, the number of illegal sales has fallen in the past year, FDA Medical Devices and Cosmetics Division Director Chien Chia-hung (錢嘉宏) said.
However, many common medical devices — such as medical-grade masks, bandages, condoms, contact lenses, gauze and thermometers — are still being sold online without a permit, he said.
People who sell medical devices without a permit face a fine of up to NT$1 million (US$31,784), in accordance with the Medical Devices Act (醫療器材管理法), Chien said.
Someone online vendors sell smart wearable devices that claim to be able to measure blood-glucose levels, which are illegal, as the FDA has not approved such products, he said.
People who import or manufacture illegal medical devices and resell or distribute them in Taiwan could face up to three years of imprisonment or detention, or a fine of up to NT$10 million, or both, the FDA said.
Low-risk medical devices — all Class 1 and some Class 2 items — can be legally sold online by pharmacies and vendors with a permit, but the FDA urged people to choose the sites they buy from carefully, verify what they are buying and use the products safely.
When buying medical devices online, people should check if the product is a low-risk medical device that can be sold online and verify if it has a valid medical device license or registration number, as well as whether the vendor has a medical device dealer permit or pharmacy license, which should be displayed on the Web site, it said.
People should carefully read the instructions and use the medical device products correctly to ensure safety, it added.
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