朝阳水碓子北京医疗器械三类经营许可证可全包代办专业快捷包下证
- 供应商
- 北京星期三企业管理咨询有限公司业务部
- 认证
- 医疗器械三类
- 注册
- 医疗器械二类
- 注册
- 注册公司
- 网络销售备案
- 手机号
- 15501182773
- 联系人
- 马胜辉
- 所在地
- 北京市海淀区清河嘉园东区甲1号楼11层1124
- 更新时间
- 2023-11-04 00:00
(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;5、房产证明、房屋租赁证明(出租方要提供产权证明)应有效;6、企业负责人、质量管理人的简历、学历证明或职称证明应有效;7、企业应根据自身实际建立医疗器械质量管理档案或表格。8、申请材料真实性
epartments; (2) the relevant departments shall accept theapplication of the applicant; (3) investigate the actual site andreview the products; (4) grant the issuance of the third iiimedical device license.2. legal basis: article 14 of theregulations on the supervision and administration of medicaldevices for the filing of class i medical devices and theapplication for the registration of class ii and class iii medicaldevices, the following materials shall be submitted: (1) productrisk analysis data; (2) technical re of the product; (3)product inspection report; (4) clinical evaluation data; (5)product specification and label samples; (6) managementsystem documents related to product development and production; 5.the property certificate and house lease certificate (the lessorshall provide the property right certificate) shall be valid; 6.the resume, educational background certificate or professionaltitle certificate of the person in charge of the enterprise and the manager shall be valid; 7. the enterprise shall establishthe management files or forms of medical devices accordingto its own actual conditions.8. authenticity of the applicationmaterials
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