Medical Devices Act｜第 71 條｜Food and Drug Administration｜Act｜In Force
第 八 章｜衛生福利部｜v1.0
Last Amended: 2020-01-15
本條規範醫療器材製造輸入的程序性違規（製造輸入不良醫材情節重大、未聘技術人員、未依規定通報或採矯正預防措施、規避普查、未下架或回收等），處2萬至50萬元罰鍰。對進口醫材的業者，上市後的通報、回收與品質管理義務同樣不可輕忽。
A fine of not less than NT$20,000 but not more than NT$500,000 shall be imposed when any of the following circumstances occurs: 1. Where a medical device firm manufactures or imports the defective medical devices set forth in Subparagraph 6 of Article 8 and commits a serious violation, or fails to make corrections within the time period that has been ordered by the competent authority in accordance with Paragraph 2 of Article 57. 2. Violating the provisions of Paragraph 1 of Article 15 by failing to employ qualified technicians. 3. Violating the provisions of Paragraph 1 or 2 of Article 19, or violating the provisions of the regulations established in accordance with Paragraph 3 of Article 19 in regard to the scope, methods for establishment and maintenance of data, retention period, report contents and methods. 4. Violating the provisions of the regulations established in accordance with Paragraph 3 of Article 24 in regard to alteration. 5. Violating the provisions of the regulations established in accordance with Paragraph 3 of Article 37 in regard to avoidance of conflicts of interest, information disclosure, supervision and administration, or inspection, or failing to make corrections within the time period that has been ordered by the competent authority in accordance with the provisions of the said regulations. 6. Violating the provisions of Article 38 by failing to report or report for recordation, or failing to report or report for recordation within a time period. 7. Violating the provisions of Article 49 by failing to conduct reporting or undertake corrective and preventive measures in accordance with the provisions. 8. Violating the provisions of Article 53 by evading, impeding, or refusing a census. 9. Violating the provisions of Paragraph 3 of Article 55 by failing to withdraw or suspend the manufacture, import, or sale. 10. Failing to give recall notices or recall medical devices within a specified time period when any of the circumstances set forth in Subparagraphs 4 through 6 of Paragraph 1 of Article 58 occurs. 11. Violating the provisions of Paragraph 2 of Article 58 by failing to cooperate in recalling medical devices. 12. Violating the provisions of the regulations established in accordance with Paragraph 3 of Article 58 in regard to the approaches for recall operation and handling methods of medical devices.
有下列情形之一者，處新臺幣二萬元以上五十萬元以下罰鍰： 一、製造或輸入第八條第六款之不良醫療器材，情節重大，或經主管機關依第五十七條第二項令其限期改正，屆期未改正。 二、違反第十五條第一項規定，未聘僱技術人員。 三、違反第十九條第一項、第二項規定，或違反依第十九條第三項所定辦法有關資料之範圍、建立或保存方式、保存年限、申報內容、方式之規定。 四、違反依第二十四條第三項所定辦法有關變更之規定。 五、違反依第三十七條第三項所定辦法有關利益迴避、資訊揭露、監督管理或查核之規定，或經主管機關依該辦法之規定令其限期改善而屆期未改善。 六、違反第三十八條規定，未通報或報備查，或未於期限內通報或報備查。 七、違反第四十九條規定，未通報，或未依規定採取矯正預防措施。 八、違反第五十三條規定，規避、妨礙或拒絕普查。 九、違反第五十五條第三項規定，未下架，或暫停製造、輸入或販賣。 十、有第五十八條第一項第四款至第六款情形之一，未為通知或未依規定期限回收醫療器材。 十一、違反第五十八條第二項規定，未配合回收醫療器材。 十二、違反依第五十八條第三項所定辦法有關醫療器材回收作業方式、處理方法之規定。
醫療器材管理法第71條：不良醫療器材、未聘技術人員、未通報等違規的2萬至50萬元罰鍰整理。
包含依規定通報、發現安全問題時採矯正預防措施、配合主管機關普查，必要時下架、回收。違反可處2萬至50萬元罰鍰。