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Medical Devices Act - Article 62

Medical Devices Act｜第 62 條｜Food and Drug Administration｜Act｜In Force

第 八 章｜衛生福利部｜v1.0

Last Amended: 2020-01-15

Content

Any person who violates Paragraph 1 of Article 25 and manufactures or imports medical devices without approval, or who violates Paragraph 2 of Article 25 and applies for listing instead of the required registration and market approval shall be subject to imprisonment for not more than three years, detention, or in addition thereto a fine of not more than NT$10,000,000. This shall also apply to any person who knowingly sells, supplies, transports, stores, engages in brokerage of, transfers, or displays with the intent to sell the medical devices set forth in the preceding paragraph.

Penalty

意圖販賣、供應而違反第二十五條第一項規定，未經核准擅自製造或輸入醫療器材，或違反第二十五條第二項規定，應辦理查驗登記而以登錄方式為之者，處三年以下有期徒刑、拘役或科或併科新臺幣一千萬元以下罰金。 明知為前項之醫療器材而販賣、供應、運送、寄藏、媒介、轉讓或意圖販賣而陳列者，亦同。

Related Regulations - Medical Devices Act

• Telecommunications Management Act - Article 80（第 80 條）
• Medical Devices Act - Article 68（第 68 條）
• Medical Devices Act - Article 60（第 60 條）
• Medical Devices Act - Article 61（第 61 條）
• Medical Devices Act - Article 63（第 63 條）
• Medical Devices Act - Article 64（第 64 條）
• Medical Devices Act - Article 65（第 65 條）