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【CODEX】2014 No.650 医疗器械监督管理条例(7-8)-EN

第七章 法律责任

Chapter VII Legal Liabilities

 

  第六十三条 有下列情形之一的,由县级以上人民政府食品药品监督管理部门没收违法所得、违法生产经营的医疗器械和用于违法生产经营的工具、设备、原材料等物品;违法生产经营的医疗器械货值金额不足1万元的,并处5万元以上10万元以下罚款;货值金额1万元以上的,并处货值金额10倍以上20倍以下罚款;情节严重的,5年内不受理相关责任人及企业提出的医疗器械许可申请:

Article 63. In any of the following circumstances, the food and drug regulatory authority of people's government at county and above level shall confiscate the illegal income, the medical device illegally manufactured and distributed, and the tools, equipment, raw materials, and other articles used for illegal production and distribution; if the value of the medical device illegally manufactured and distributed is less than RMB 10,000, a fine above RMB 50,000 but less than RMB 100,000 shall be imposed; if the value of the medical devices is above RMB 10,000, a fine more than 10 times but no more than 20 times of the value of the goods shall be imposed; in serious cases, the licensing application for medical device submitted by relevant responsible person and enterprise shall not be accepted within five years:

 

(一) 生产、经营未取得医疗器械注册证的第二类、第三类医疗器械的;

(1)   Manufacture and distribute Class II and Class III medical devices without obtaining the Medical Device Registration Certificate;

 

(二) 未经许可从事第二类、第三类医疗器械生产活动的;

(2)   Engage in the manufacturing activities of Class II and Class III medical device without licensing;

 

(三) 未经许可从事第三类医疗器械经营活动的。

(3)   Engage in the operating activities of Class III medical devices without licensing.

 

有前款第一项情形、情节严重的,由原发证部门吊销医疗器械生产许可证或者医疗器械经营许可证。

In serious cases for Item 1, the Medical Device Manufacturing License and Medical Device Distributing License shall be revoked by original issuing authority.

 

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