怀柔渤海镇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
(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;医疗器械二类备案流程: 1、准备执照副本,
5.现场评价;
6.有关部门的行政决定;
7.制证、发证。
办理三类医疗器械经营许可证的条件如下:
1、具有与经营范围相匹配的经营场所和仓库,并对其具体面积有具体要求;
2、具有国家认可的、与经营产品相关专门的在岗人员;
3、具有与经营产品相关的拥有中专以上学历的技术人员;
4、拥有与经营的医疗器械相适应的质量管理制度
cant's application; (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 and apply for the registration of Class II and III medical devices shall submit the following materials: (1) product risk analysis data; (2) the product technical requirements; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product instructions and label samples; filing process of medical devices: 1. copy of license; 5. on-site evaluation; 6. administrative decisions of relevant departments; 7. Certificate making and issuance. The conditions for handling the business license of Class III medical devices are as follows: 1. business premises and warehouses matching with business scope with specific requirements for their specific area; 2. Specialized duty personnel related to business products; 3. technical personnel with technical secondary school or above related to business products; 4. quality managem