海淀厂洼北京办理医疗器械三类经营许可证没有库房怎么办包下证快捷
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;
请不予受理或者不予核发《医疗器械经营企业许可证》,并给予警告。申请人在1年内不得再次申请《医疗器械经
w to handle the business license of third III medical devices is as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant's application; (3) investigate the actual site and review the products; (4) grant the issuance of the third III medical device license.2. Legal basis: Article 14 of the Regulations on supervision and Administration of Medical Devices for product filing of category I medical devices and application for product registration of Class II and Class III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; Please do not accept or issue the Medical Device Operating Enterprise License, and give you a warning. The applicant shall not apply for the Medical device document again within one year