【CODEX】医疗器械经营监督管理办法（5-6）-EN
第五章 法律责任
Chapter V Legal Responsibility
第五十三条 有下列情形之一的，由县级以上食品药品监督管理部门责令限期改正，给予警告；拒不改正的，处5000元以上2万元以下罚款：
Article 53.In case of any of the following circumstances, the food and drug regulatory authority above county level will order the enterprise to rectify within a time limit and send a warning. In case of refusal to rectify, a fine of 5 000 to 20 000 RMB will be imposed:
（一）医疗器械经营企业未依照本办法规定办理登记事项变更的；
(1)The medical device distributor does not register item changes according to the Provisions;
（二）医疗器械经营企业派出销售人员销售医疗器械，未按照本办法要求提供授权书的；
(2)The medical device distributor sends sales persons to sell medical device without providing the letter of authorization according to the Provisions;
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