海淀知春路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经验丰富靠谱Zui快7天下证

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。

关于在京办理三类医疗器械经营许可证的更多问题，欢迎私信小编，



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。

3、销售三类医疗器械，你必须要自己的库房，库房里需要设置冷藏库，因

management system that meets the quality requirements ofbusiness management of medical devices to ensure the traceabilityof business products. 3. A sales record system and a qualitymanagement self-inspection system shall be established. 4. Whensuspending business for more than one year and re-operating, itshall submit a written report in advance to the food and drugsupervisory and administrative department of the city where it islocated, and shall resume business only after checking that itmeets the requirements. About more questions about the third classof medical device business license in Beijing, welcomeprivate