1）申请人提交申请资料到相关部门；
（2）相关部门受理申请人的申请；
（3）到实际场地进行勘察以及对产品进行审核；
（4）准予颁发三类医疗器械许可证。
2、法律依据：《医疗器械监督管理条例》第十四条
第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；
二、三类医疗器械许可证注册需要什么材料1、经营企业提交的《医疗器械经营
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，而且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，所以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**把库房收拾一下，然后领取《医疗器械经营企业许可
ical devices: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product instructions and label samples; what materials are required for the registration of Class III medical devices; 1. the operation of medical devices submitted by the operating enterprise Many distributors of drugs or medical devices can not sell many products without the business license of third class medical devices. For example, in vitro diagnostic reagents belong to the third class medical devices, and only with relevant certificates can they sell such products.2. In order to apply for the business license of the third types of medical devices, there must be a relevant business license. In the business scope of the general business license, it is necessary to be clearly stated that the third types of medical devices can be sold. If not, the need to go to the industrial and commercial bureau for additional items.3, the sales of the third class of medical devices, you must have their own warehouse, and the warehouse needs to set up cold storage, because the third class of medical devices, is the need for insulation, beyond a certain temperature, it is easy to deteriorate and affect the quality of products, so few dealers are qualified to sell the third class of medical devices.4, go to the industrial and commercial bureau for additional items, is the need to take the staff of the industrial and commercial bureau to check the warehouse, you had better clean up the wa
