（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；
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**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
ical devices can not sell many products without the businesslicense of third class medical devices. For example, in vitrodiagnostic reagents belong to the third class medical devices, andonly with relevant certificates can they sell such products.2. Inorder to apply for the business license of the third types ofmedical devices, there must be a relevant business license. In thebusiness scope of the general business license, it is necessary tobe clearly stated that the third types of medical devices can besold. If not, the need to go to the industrial and commercialbureau for additional items.3, the sales of the third class ofmedical devices, you must have their own warehouse, and thewarehouse needs to set up cold storage, because the third class ofmedical devices, is the need for insulation, beyond a certaintemperature, it is easy to deteriorate and 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 Industrialand commercial Bureau to check the warehouse, you had better cleanup the warehouse, and then get
