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;
(六)与产品研制、生产有关的质量管理体系文件;6.有关部门的行政决定;
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。
license is handled as follows: (1) the applicant submits theapplication materials to the relevant departments; (2) the relevantdepartments accept the application of the applicant; (3)investigate the actual site and reviews the product; (4) grant theissuance of the third III medical device license.2. Legal basis:Article 14 of the Regulations on the Supervision and Administrationof Medical Devices for the filing of Class I medical devices andthe application for the registration of Class II and Class IIImedical devices, The following materials shall be submitted: (1)product risk analysis data; (2) technical requirements of theproduct; (3) product inspection report; (4) clinical evaluationdata; (5) product specification and label samples; (6) qualitymanagement system documents related to product development andproduction; 6. Administrative decisions of relevant departments;distributors 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.