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；10、申请材料应完整、清晰、签字，并逐份加盖公章，
1、具有与经营范围相匹配的经营场所和仓库，并对其具体面积有具体要求；
2、具有国家认可的、与经营产品相关专门的在岗人员；
3、具有与经营产品相关的拥有中专以上学历的技术人员；
4、拥有与经营的医疗器械相适应的质量管理制度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。1.Having the business premises and warehouses matching with thebusiness scope, And have specific re for the specificarea; 2, with the state recognized, related to the management ofproducts; 3, with a technical secondary school education; 4, withthe management of medical devices with the managementsystem of the dealers of many drugs or medical devices, Without theoperating license, A lot of products can't be sold, In vitrodiagnostic reagents, for example, belong to three categories ofmedical devices, Only with the relevant certificates, To sell theproduct.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, sellingthree
3、销售三类医疗器械，你必须要自己的库房