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。
ass medical devices, and only with relevant certificates cansuch products be sold. 2. In order to apply for the businesslicense of the third types of medical devices, there must be arelevant business license. In the column of the business scope onthe general business license, it is necessary to be clearly statedthat the third types of medical devices can be sold. If not, theneed to go to the industrial and commercial bureau for additionalitems. 3, the sales of the third class of medical devices, you musthave their own warehouse, and the warehouse needs to set up coldstorage, because the third class of medical devices, is the needfor insulation, beyond a certain temperature, it is easy todeteriorate and affect the quality of products, so few dealers arequalified to sell the third class of medical devices. 4, go to theindustrial and commercial Bureau for additional items, is the needto take the staff of the industrial and commercial bureau to checkthe warehouse, yo
