朝阳十八里店北京医疗器械三类经营许可证二三类专业快捷包拿证
(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。
1、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
application materials to the relevant departments; (2) Relevant departments shall accept the application of the applicant; (3) Investigate the actual site and audit the products; (4) Grant the issuance of a class III medical device license. 2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices As for the registration of Class II and III medical devices, the following materials shall be submitted: (1) Product risk analysis data; (2) Technical requirements for the products; (3) Product inspection report; (4) Clinical evaluation data; (5) Product specification 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. 3, the sales of the third class of medical devices, you must have their own warehouse, and the warehouse needs to set up cold storage, because the third class of medical devices, is the need for insulation, beyond a certain temperature, it is easy to deteriorate and affect the quality of products, so few dealers are qualified to sell three types of medical devices. 4, go to the industrial and commercial bureau for additional items, is the need to take the staff of the industrial and commercial bureau to check the warehouse, you had better clean up the warehouse, and then get the " medical equipment business enterprise license