大兴西红门北京医疗器械二类备案医疗器械三类经营许可证专业办理Zui详细的教程快来看

1、医疗器械经营许可证的有效期只有5年。有效期届满需要延续的，医疗器械经营企业应当在有效期届满6个月前，向原发证部门提出《医疗器械经营许可证》延续申请。

2、应当具有符合医疗器械经营质量管理要求的计算机信息管理系统，保证经营产品的可追溯。

3、应当建立销售记录制度和建立质量管理自查制度。

4、自行停业一年以上，重新经营时，应当提前书面报告所在地设区的市级食品药品监督管理部门，经核查符合要求后方可恢复经营。

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一、三类医疗器械经营许可证如何办理

1、很多药品或者医疗器械的经销商，如果没有三类医疗器械经营许可证，很多产品就不能卖，比如说体外诊断试剂就属于三类医疗器械，只有有相关证书，才能销售这种产品。

2、要办理三类医疗器械经营许可证，必须有相关的营业执照，一般营业执照上的经营范围这一栏，需要明确写道可以销售三类医疗器械。如果没有，需要去工商局办理增项。

than one year and re-operating, it shall submit a written report in advance to the food and drug supervisory and administrative department of the city where it is located, and shall resume business only after checking that it meets the requirements. About more questions about the third class of medical device business license in Beijing, welcome private messages, how to handle the first and third class of medical device business license 1. Many distributors of drugs or medical devices cannot be sold without the business license of third class medical devices. For example, in vitro diagnostic reagents belong to third class medical devices, and only with relevant certificates can such products be sold. 2. In order to