Medical Devices Act｜第 68 條｜Food and Drug Administration｜Act｜In Force
第 八 章｜衛生福利部｜v1.0
Last Amended: 2020-01-15
本條對較重大的醫材違規處6萬至200萬元罰鍰，包含購入或承租未查驗登記、非醫材商供應之醫材，未符醫療器材製造業者設置標準或品質管理系統準則，以及將「專供外銷」醫材在國內銷售等。集運進口醫材若來源未經登記，採購端與販售端都可能受罰。
A fine of not less than NT$60,000 but not more than NT$2,000,000 shall be imposed when any of the following circumstances occurs: 1. Violating the provisions of Article 17 by purchasing or renting medical devices that have not been registered and approved or listed, or medical devices supplied by those other than medical device firms. 2. Violating the provisions of Paragraph 1 of Article 20 by failing to meet the Establishment Standards for Medical Device Manufacturers. 3. Where domestic medical device manufacturers violating the provisions of Paragraph 1 of Article 22 by failing to comply with the medical device quality management system regulations, or violating the provisions of Paragraph 2 of Article 22 by manufacturing medical devices without obtaining manufacturing license. 4. Where medical device dealers importing medical devices that have been manufactured in violation of the provisions of Paragraph 3 of Article 22 as applied mutatis mutandis pursuant to Paragraph 1 or Paragraph 2. 5. Violating the provisions of Paragraph 1 of Article 25 by manufacturing or importing medical devices without applying for registration and market approval or listing, or violating the provisions of Paragraph 2 of Article 25 by applying for listing instead of the required registration and market approval. 6. Violating the provisions of Paragraph 3 of Article 34 by selling domestically the medical devices that are for export only. When the circumstances set forth in Subparagraph 3 or 4 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 manufacture, import, and business operations may be suspended in part or in whole. If no corrections are made within the time period, extension of medical device license in accordance with Article 27 shall not be approved or annual declaration in accordance with Article 28 shall not be filed, and any new applications for registration and market approval or listing of other medical devices of the manufacturers shall not be accepted. In the case of serious violation, the central competent authority may also cancel all or part of the medical device manufacturing licenses, licenses, or listings.
有下列情形之一者，處新臺幣六萬元以上二百萬元以下罰鍰： 一、違反第十七條規定，購入或承租未經查驗登記、登錄或非醫療器材商供應之醫療器材。 二、違反第二十條第一項規定，未符合醫療器材製造業者設置標準。 三、國內醫療器材製造業者，違反第二十二條第一項規定，未符合醫療器材品質管理系統準則，或違反第二十二條第二項規定，未取得製造許可擅自製造醫療器材。 四、醫療器材販賣業者輸入違反第二十二條第三項準用第一項或第二項規定所製造之醫療器材。 五、違反第二十五條第一項規定，製造、輸入醫療器材未辦理查驗登記或登錄，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。 六、違反第三十四條第三項規定，將專供外銷之醫療器材於國內銷售。 有前項第三款或第四款情形者，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製造、輸入或營業；屆期未改善者，不得依第二十七條規定展延醫療器材許可證，或依第二十八條規定辦理年度申報，且不受理該製造業者其他醫療器材查驗登記或登錄之新申請案；其情節重大者，並得廢止其全部或一部之醫療器材製造許可、許可證或登錄。
醫療器材管理法第68條：購入未查驗登記醫材、未符製造業者標準、專供外銷品國內販售等的重罰（6萬至200萬元）。
會。違反規定購入或承租未經查驗登記、登錄或非醫療器材商供應之醫療器材，可處6萬至200萬元罰鍰。採購醫材務必確認供應商與產品皆已合法登記。