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成都某义齿公司违法生产1颗未注册义齿被罚没逾4万元

 
Issuing time:2025-09-29 14:40Author:编辑部
*图源：四川省药品监督管理局官网
*图源：四川省药品监督管理局官网

好的牙·讯｜四川省药品监督管理局近日公布了对成都某义齿有限公司作出的行政处罚决定（川药监罚决〔2025〕1014号）。该公司因生产、经营未取得医疗器械注册证的第二类医疗器械，被处以罚没款共计人民币44010元。

行政处罚决定信息公开表显示，该义齿公司在未向四川省药品监督管理局申请办理第二类医疗器械定制式固定义齿（增加规格型号）变更注册的情况下，违法生产桩核类定制式固定义齿。该行为违反了《医疗器械监督管理条例》相关规定。

《医疗器械监督管理条例》第八十一条明确规定，对于生产、经营未取得医疗器械注册证的第二类、第三类医疗器械等情形，药品监督管理部门将没收违法所得、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，并根据货值金额处以罚款。

四川省药品监督管理局依据上述条例规定，对该义齿公司作出以下行政处罚决定：没收违法生产的1颗桩核类定制式固定义齿；没收销售该产品的违法所得人民币4010元；并处罚款人民币40000元。

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