械经营许可证如何办理
1、三类医疗器械经营许可证办理方式如下:
(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;医疗器械二类备案流程:1、准备执照副本,
7、企业应根据自身实际建立医疗器械质量管理档案或表格。
8、申请材料真实性的自我保证声明应由法定代表人签字并加盖企业公章,如无公章,则须有法定代表人本人
le the business license of third III medical devices is asfollows: (1) the applicant submits the application materials to therelevant departments; (2) the relevant departments accept theapplication of the applicant; (3) investigate the actual site andreview the product; (4) granting the issuance of the third IIImedical device license.2. Legal basis: Article 14 of theRegulations on Supervision and Administration of Medical DevicesFor the filing of Class I medical devices and the application forthe registration of Class II and III medical devices, the followingmaterials shall be submitted: (1) product risk analysis data; (2)product technical requirements; (3) product inspection report; (3)(4) clinical evaluation data; (5) product description and labelsamples; the filing process of medical devices: 1. Prepare a copyof the license, 7. The enterprise shall establish the qualitymanagement files or forms of medical devices according to its ownactual conditions. 8. The self-guarantee statement of theauthenticity of the application materials shall be signed by thelegal representative and affixed with the official seal of theenterprise. If there is no official seal, the legal representativehimself shall be includ