一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册，应当提交下列资料：
（一）产品风险分析资料；
（二）产品技术要求；
（三）产品检验报告；
（四）临床评价资料；
（五）产品说明书以及标签样稿；
6.有关部门的行政决定；
7.制证、发证。
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
the third types of medical devices, there must be a relevantbusiness license. In the business scope of the general businesslicense, it is necessary to be clearly stated that the third typesof medical devices can be sold. If not, the need to go to theindustrial and commercial bureau for additional items.3, the salesof the third class of medical devices, you must have their ownwarehouse, and the warehouse needs to set up cold storage, becausethe third class of medical devices, is the need for insulation,beyond a certain temperature, it is easy to deteriorate and affectthe quality of products, so few dealers are qualified to sell thethird class of medical devices.4, to the industrial and commercialbureau for additional items, is the need to take the industrial andcommercial bureau
