Medical Devices Act｜第 70 條｜Food and Drug Administration｜Act｜In Force
第 八 章｜衛生福利部｜v1.0
Last Amended: 2020-01-15
本條對醫療器材商相關違規處3萬至100萬元罰鍰，包含未辦醫療器材商登記、未符醫療器材優良運銷準則(GDP)、未取得運銷許可擅自輸入、販售未查驗登記之醫材、包裝標示違規等。對想集運進口血壓計、隱形眼鏡、體外診斷試劑等醫療器材的客戶，務必先確認是否屬醫材及所需許可，以免觸法。
A fine of not less than NT$30,000 but not more than NT$1,000,000 shall be imposed when any of the following circumstances occurs: 1. Violating the provisions of Paragraph 1 of Article 13 by engaging in the business activities of medical device firms without being a medical device firm, or violating the provisions of Paragraph 2 of Article 13 by failing to complete change registration for any change in the particulars registered. 2. Violating the provisions of Paragraph 3 of Article 13 by failing to complete medical device firm registration or failing to manufacture, sell, or supply medical devices at the registered place. 3. Violating the limitations announced in accordance with Article 18. 4. Violating the provisions of the regulations established in accordance with Paragraph 4 of Article 22 in regard to alteration. 5. Violating the provisions of Paragraph 1 of Article 23 by authorizing the commissioning or accepting the commissioning to manufacture medical devices without approval, or violating the provisions of Paragraph 2 of Article 23 by manufacturing medical devices. 6. Violating the provisions of Paragraph 1 of Article 24 by failing to comply with the regulations for good distribution practice of medical devices, or violating the provisions of Paragraph 2 of Article 24 by engaging in wholesale, import, or export of medical devices without obtaining a distribution license. 7. Violating the provisions of Paragraph 1 of Article 25 by selling, supplying, transporting, storing, engaging in brokerage of, transferring, or displaying with the intent to sell medical devices without applying for registration and market approval or listing. 8. Violating the provisions of Article 26 by making alteration to any of the original particulars of registration and market approval or listing without approval. 9. Violating the provisions of Article 32 or 33 in regard to the packaging, labels, and instructions of medical devices or the particulars indicated thereof. 10. Violating the provisions of the regulations established in accordance with Paragraph 2 of Article 35 in regard to restrictions on supply and sale or return. 11. Violating the provisions of Paragraph 1 of Article 37 by implementing a clinical trial without approval, or violating the provisions of Paragraph 2 of Article 37 by failing to obtain consent from human subjects prior to implementing the clinical trial. 12. Violating the provisions of Paragraph 1 of Article 48 by failing to report to the central competent authority, or violating the provisions of Paragraph 2 of Article 48 in regard to the conditions, reporting methods, time period, and contents. 13. Violating the provisions of Article 51 by evading, impeding, or refusing an inspection or random testing. When the circumstances set forth in Subparagraph 6 of the preceding paragraph occur, in addition to the punishments that shall be imposed in accordance with the preceding paragraph, the central competent authority may publicize the names of the medical device firms and order them to make corrections within a time period, during which their wholesale, retail, import, and export may be suspended in part or in whole. For those who fail to make corrections within the time period, a consecutive sentence may be imposed for each violation until the corrections are made.
有下列情形之一者，處新臺幣三萬元以上一百萬元以下罰鍰： 一、違反第十三條第一項規定，非為醫療器材商而為醫療器材商之業務，或違反第十三條第二項規定，登記事項變更未辦理變更登記。 二、違反第十三條第三項規定，未辦理醫療器材商登記，或未於登記處所製造、販賣或供應醫療器材。 三、違反依第十八條所為公告之限制規定。 四、違反依第二十二條第四項所定辦法有關變更之規定。 五、違反第二十三條第一項規定，未經核准而委託或接受委託製造醫療器材，或違反第二十三條第二項規定製造醫療器材。 六、違反第二十四條第一項規定，未符合醫療器材優良運銷準則，或違反第二十四條第二項規定，未取得運銷許可擅自批發、輸入或輸出醫療器材。 七、販賣、供應、運送、寄藏、媒介、轉讓或意圖販賣而陳列未依第二十五條第一項規定，辦理查驗登記或登錄之醫療器材。 八、違反第二十六條規定，未經核准擅自變更原查驗登記或登錄事項。 九、違反第三十二條或第三十三條關於醫療器材包裝標示、標籤、說明書或其刊載事項之規定。 十、違反依第三十五條第二項所定辦法有關供售限制或退運之規定。 十一、違反第三十七條第一項規定，未經核准擅自執行臨床試驗，或違反第三十七條第二項規定，執行臨床試驗未先取得受試者之同意。 十二、違反第四十八條第一項規定，未通報中央主管機關，或違反依第四十八條第二項所定辦法有關通報方式、期限、內容之規定。 十三、違反第五十一條規定，規避、妨礙或拒絕檢查或抽驗。 有前項第六款情形者，除依前項規定處罰外，中央主管機關得公布醫療器材商名稱，並令其限期改善，改善期間得停止其全部或一部醫療器材之批發、零售、輸入及輸出；屆期未改善者，得按次處罰至改善為止。
醫療器材管理法第70條：進口、販售醫療器材未登記或未符優良運銷準則的重罰（3萬至100萬元）——集運進口醫材必看風險。
醫療器材（如隱形眼鏡、血壓計、體溫計、部分美容儀）多屬查驗登記管理品項，未經查驗登記擅自輸入販售可處3萬至100萬元罰鍰。個人自用通常有數量限制，商業進口則須取得醫療器材商登記與相關許可。
須辦理醫療器材商登記、符合醫療器材優良運銷準則(GDP)並取得運銷許可，產品本身須完成查驗登記或登錄。建議委託專業報關行確認品項分類與簽審需求。