海淀温泉北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证
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;
(六)与产品研制、生产有关的质量管理体系文件;
(七)证明产品安全、有效所需的其他资料。4、工商行政管理部门出具的《企
3、销售三类医疗器械,你必须要自己的库房,而且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,所以很少有经销商有销
ws: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices For the filing of Class I medical devices and the application for the registration of Class II and 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 instructions and label samples; (6) quality management system documents related to product development and production; (7) other materials required to prove the safety and effectiveness of the product.4, the administrative department of industry and commerce issued by the " enterprise 3, sales of three types of medical equipment, you must want their own warehouse, and the warehouse needs to set up cold storage, because the three types of medical equipment, is insulation need, beyond a cert