Medical Devices Act｜第 65 條｜Food and Drug Administration｜Act｜In Force
第 八 章｜衛生福利部｜v1.0
Last Amended: 2020-01-15
Any person violating the provisions of Article 46 and labeling or promoting non-medical devices as having therapeutic effects shall be subject to a fine of not less than NT$600,000 but not more than NT$25,000,000. A fine of not less than NT$200,000 but not more than NT$5,000,000 shall be imposed when any of the following circumstances occurs: 1. Violating the provisions of Article 40 and engaging in advertising of medical devices without being a medical device firm. 2. Violating the provisions of Paragraph 1 of Article 41 and failing to apply for approval or forward approval documents to mass media enterprises for verification before publishing or broadcasting a medical device advertisement. 3. Violating the provisions of Paragraph 2 of Article 41 and modifying or altering the originally approved contents of a medical device advertisement without approval. 4. Violating the restrictions on the extent of publishing or broadcasting medical device advertisements specified in Article 44. 5. Where medical devices are advertised in any of the manners set forth in the provisions of Article 45. 6. Where a medical device firm fails to give a notice or recall medical devices within the specified time period under any of the circumstances set forth in Subparagraphs 1 through 3 of Paragraph 1 of Article 58.
違反第四十六條規定，非醫療器材為醫療效能之標示或宣傳者，處新臺幣六十萬元以上二千五百萬元以下罰鍰。 有下列情形之一者，處新臺幣二十萬元以上五百萬元以下罰鍰： 一、違反第四十條規定，非醫療器材商為醫療器材廣告。 二、違反第四十一條第一項規定，醫療器材廣告未於刊播前申請核准或向傳播業者送驗核准文件。 三、違反第四十一條第二項規定，醫療器材廣告未經核准擅自變更原核准事項。 四、違反第四十四條所定醫療器材廣告登載範圍之限制。 五、醫療器材廣告方式，有第四十五條規定情形之一。 六、有第五十八條第一項第一款至第三款情形之一，未為通知或未依規定期限回收醫療器材。