医疗器械生产企业许可证

点击: 发布时间:2016-11-29

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申办材料要求;
Application data required:
1、《医疗器械生产许可申请表》;
    Application Form for Production Permit of Medical Devices
2、营业执照、组织机构代码证复印件;
   Business license, organization code certificate (copies)
3、申请企业持有的所生产医疗器械的注册证及产品技术要求复印件;
   Registration certificate for production of medical devices held by applicant and technical requirements of products (copies)
4、法定代表人、企业负责人身份证明复印件;
   ID certificates of legal representative and enterprise’s principal (copies)
5、生产、质量和技术负责人的身份、学历、职称证明复印件;
   ID, education background and title of principals of production, quality and technique (copies)
6、生产管理、质量检验岗位从业人员学历、职称一览表;
   Education background and title list of production management and quality testers
7、生产场地的证明文件(规划用途或设计用途不应为“住宅”),包括租赁协议、房产证明(或使用权证明)的复印件;厂区位置路线图、厂区总平面图、主要生产车间布置图,有洁净要求的车间,须标明功能间及人流、物流走向同时提供洁净室的合格检测报告复印件(检测报告应是由省级食品药品监督管理部门认可的检测机构出具的近一年内的符合《无菌医疗器具生产管理规范》(YY0033)的合格检测报告);
Certificates of production site (the given and designed purpose shall be not domicile), including lease agreement, house property certificate (or certificate of use right) (copies); plant area route map, overall plan, main production workshop layout, the workshop requiring to be clean shall be marked with function room, person flow and material flow direction, submit qualification test report of clean room (copies)(The test report shall be issued by a testing agency approved by provincial-level food and drug administration, which shows it complies with the Code for Production and Management of Aseptic Medical Apparatus and Instruments (YY0033) in recent one year).
8、主要生产设备和检验设备目录;
   List of main production and test equipment
9、质量手册和程序文件目录;
   List of quality manual and program documents
10、工艺流程图,并注明主要控制项目和控制点,包括关键和特殊工序的设备、人员及工艺参数控制的说明;
    Process flow diagram, indicating main control items and points, including explanations for special procedure equipment, personnel and process parameter control
11、申报材料真实性的自我保证声明,包括企业对材料作出如有虚假承担法律责任的承诺;
    Self guarantee and statement for the authenticity and application data, including commitments to undertake legal responsibilities for any false data by the enterprise
授权委托书12、申请企业出具的申办人员《
    Authorization issued by the enterprise to handling persons
服务内容
Service Scope
生产法规培训 生产场地评估
Training of production rules          Production site evaluation
申报资料整理   体系建立指导
Process of application data           System creation instruction
场地指导验收 行政审批沟通
Site instruction acceptance           Administrative review and communication
业务流程
Business Flow
签订许可代理合同
Sign contract of permit agency
指导客户组织申请材料
Instruct clients to collect application data
提交CFDA受理(7个工作日)
Submit to CFDA for acceptance (7 workdays)
生产现场查验
Production site inspection
行政审批、制证(20个工作日)
Administrative review and certificate making (20 workdays)
取得医疗器械生产许可证
Issue of production permit of medical devices
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