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;
办理三类医疗器械经营许可证的条件如下:
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,需要直接去市
methods for handling the business license are as follows: (1)the applicant submits the application materials to the relevantdepartments; (2) the relevant departments accept the application ofthe applicant; (3) investigate the actual site and reviews theproducts; (4) grant the issuance of the third-class medical devicelicense.2. Legal basis: Article 14 of the Regulations on theSupervision and Administration of Medical Devices for the filing ofClass I medical devices and the application for the registration ofClass II and Class III medical devices, The following materialsshall be submitted: (1) product risk analysis data; (2) technicalrequirements of the product; (3) product inspection report; (4)clinical evaluation data; the conditions for handling the businesslicense of Class III medical devices are as follows: 3. Sales ofClass III medical devices, You have to have your own warehouse, Andthe warehouse needs to set up cold storage, Because of the ClassIII medical devices, There is a need for thermal insulation, Abovea certain temperature, It is easy to deteriorate and affect thequality of products, So very few dealers are qualified to sellthree types of medical devices.4, go to the Industrial andcommercial Bureau for additional items, is the need to take thestaff of the Industrial and commercial Bureau to check thewarehouse, you had better clean up the warehouse, and then get the"medical device business enterprise license application form" andfill in, and bring all the relevant qualifications of theenterprise, but also need to bring the relevant information ofquality personnel.5. The business license of class III medicaldevices needs to go directly to the