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,
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,需要直接去市级人民政府食品药品监督管理部门办理,在接受资料后的30天内进行审核,如果
ws: (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 products; (4) grant the issuance of the Class 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 application for theregistration of Class II and Class III medical devices, thefollowing materials shall be submitted: (1) product risk analysisdata; (2) product technical re; (ii) product technicalre; (3) product inspection report; (4) clinicalevaluation data; (5) product instructions and label samples; filingprocess of medical devices: 1. Prepare copies of license, so fewdistributors are to sell Class III medical devices.4, goto the Industrial and commercial Bureau for additional items, isthe need to take the staff of the Industrial and commercial Bureauto check the warehouse, you had better clean up the warehouse, andthen get the "medical device business enterprise licenseapplication form" and fill in, and bring all the relevant of the enterprise, but also need to bring therelevant information of personnel.5. The business licenseof Class III medical devices needs to be handled directly by thefood and drug supervision and administration department of themunicipal people's government, and shall be reviewed within 30 daysafter receiving the materials, if