拋棄式隱形眼鏡目前十分普及,在各眼鏡行均可輕易購買。因此民眾可能會誤 以為其為非管制性的商品,甚至想要透過網路販售手邊多餘、不再使用的拋棄 式眼鏡。
事實上,依「醫療器材管理法」、「醫療器材分類分級管理辦法」,隱形眼鏡(不論硬、軟式)屬中風險甚至高風險之醫療器材。而依據醫療器材管理法第13條之規定,販賣醫療器材,「應申請直轄市或縣(市)衛生主管機關核准登記,領得許可執照後,方准營業。」
從而,一般民眾未經核准登記為醫療器材商,不得販賣屬醫療器材之隱形眼 鏡。違反者依醫療器材管理法第70條規定,可處新臺幣三萬元以上一百萬元以下罰鍰。
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Disposable contact lenses are widely used today and can be easily purchased from most optical stores. Because of this, many people mistakenly assume that contact lenses are not regulated items - and may even try to sell unused or leftover lenses online without realizing it's illegal.
In fact, according to the Medical Devices Act and the Regulations Governing the Classification of Medical Devices, contact lenses - whether hard or soft-are classified as medium to high-risk medical devices. Under Article 13 of the Medical Devices Act, "Any business with the intent to become a medical device firm shall file an application with the municipal or county/city competent authority for approval and registration, and shall start the operation only after having obtained the business permit."
Therefore, ordinary individuals who are not officially registered and licensed as medical device firms are not allowed to sell contact lenses, which are classified as medical devices. Those who violate this regulation may be fined between NT$30,000 and NT$1,000,000, in accordance with Article 70 of the Medical Devices Act.
May 3, 2025