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,因为三类医疗器械,是有保温需要的,超过一定的温度,就容易变质影响产品质量,很少有经销商有销售三类医疗器械的资格。
4、去工商局办理增项,是需要带着工商局的工作人员来查看库房的,你zui好把库房收拾一下,领取《医疗器械经营企业许可申请表》并填写,并把企业相关资质全部带上,还需要带上质量人员的相关资料。
5、三类医疗器械经营许可证,需要直接去市级人民政府食品药品监督管理部门办理,在接受资料后的30天内进行审核,如果符合相关规定,就可以颁发三类医疗器械经营许可证。
es, and only with relevant certificates can such products besold. 2. In order to apply for the business license of the thirdtypes of medical devices, there must be a relevant businesslicense. In the business scope of the general business license, itis necessary to be clearly stated that the third types of medicaldevices can be sold. If not, the need to go to the industrial andcommercial bureau for additional items. 3, the sales of the thirdclass of medical devices, you must have their own warehouse, andthe warehouse needs to set up cold storage, because the third classof medical devices, is the need for insulation, beyond a certaintemperature, it is easy to deteriorate affect the quality ofproducts, so few dealers are qualified to sell three types ofmedical devices. 4, go to the industrial and commercial Bureau foradditional items, is the need to take the staff of the indu