1、医疗器械注册工作 要求及文件形成可大年目录1 医疗器械设计开发控制(含软件)2 国际注册材料清单及摘要CFDA软件器械注册材料清单及摘要第一部分设计和开发控制程序目的 Purpose1 规定产品设计开发各阶段的要求和职责,确保产品 满足预定的设计需要和最终市场需求。Specify the requirement and responsibility for product design and development,ensure that the product meet the predetermined requirements for design.2 满足13485-7.3要求注册材
2、料要求(设计开 发控制程序)即:是国内注册的要求是国外注册的要求国内注册申报资料一级目录申报资料二级目录1.申请表2.医疗器械安全有效基本要求清单3.综述资料3.1无源产品 或 3.2有源产品3.型号规格4.包装说明5.适用范围和禁忌症6.与国内外已上市产品的比较4.风险管理资料5.研究资料1.产品技术要求研究2.生物相容性评价3.生物安全性研究4.灭菌和消毒工艺研究5.有效期和包装研究6.动物研究7.软件研究6.生产制造信息6.1 无源产品 或 6.2有源产品6.3 生产场地信息7产品技术要求8产品检验报告1.注册检验报告2.预评价意见表9临床评价资料9.1对比说明和临床评价报告 或 9.2
3、临床试验报告10说明书和标签样稿1.说明书2.最小销售单元的标签样稿11证明性文件12符合性声明国外注册要求(CE)1.Introduction2.Essential Requirements Checklist3.Risk Analysis4.Drawings,Design,-Product-SpecificationsChemical,physical and biological tests5.1 In Vitro Testing-Preclinical Studies5.2 Biocompatibility Tests5.3 Biostability Tests5.4 Microbio
4、logical Safety,Animal origin tissue5.5 Coated Medical Devices6.Clinical Data7.Package Qualification and Shelf life8.Labels-Instructions for use-patient informations-advertising materials9.Manufacturing10.Sterilization11.Conclusion12.Declaration of Conformity(Draft)国外注册要求(CE)适用范围 Scope适用于本公司设计和生产的所有医
5、疗器械,包括新产品研发和现有产品的改进等,包括:开发 设计更改(升级)Apply to all medical devices applicable to which willbe design and manufactured by Medical Zenith,including new products or enhancement to the existing product.职责Responsibility职责Responsibility总裁负责批准列项 President approve the project职责Responsibility技术副总裁(VP-CTO):项目组的组
6、建;费用预算;进度计划;负责批准设 计和开发的输入评审、样品评审、设计评审和 通过,及相关文件的批准,具体要求详见设计控 制核对表.Vice-president of technic:has the responsibility for set up project team,design and development input review,and prototype review,and design review or,and approve the other files.See design control checklist.职责Responsibility项目组:由研发部、市
7、场营销部、品质部、制造 部、临床注册部、财务部的相应人员共 同组成,担当项目的全部设计和开发任 务。Project Team consists of related personnel from R&D Dept,Marketing Dept,Quality Dept,Manufacture Dept,registration and clinical testing,Finance Dept,has the responsibility to achieve all the tasks of design and development.职责Responsibility项目负责人责任及基本要
8、求:1 团队工作方式,团队内外的沟通;work way of the project team,Communication inner and outer the team.2 计划与责任(按照设计开发控制程序);项目全计划:各阶段计划,整体计 划更新;年计划,季度计划(第一季度细化),月计划,周计划;谁来完成Plan and Responsibility(according to the design and development control procedure);The whole plan of project:quarterly plan(detail the plan of t
9、he first quarter),monthly plan,weekly plan3 研发,设计开发控制,质量体系,动物实验,临床,注册要求;各方面法 规要求4 资源弥补素质不足的必备素质项目组成员职位及职责描述职位职责描述技术副总裁(VP-CTO)负责批准列项;项目组的成立;费用预算、进度计划;负责批准设计和开发的输入评审、样品评审、设计评审和通过,及 其他文件的批准,具体要求详见设计控制核对表.项目负责人负责成立项目组、负责项目的整体策划、阶段策划,管理项目组;执行设计和开发控制程序,组织设计和开发各阶段的评审;负责设计开发输入、输出文件、记录的审核;负责项目组与各职能部门的协调与沟通;
10、国外同类产品状况跟踪和调研、市场反馈、产品动向;动物实验安排、临床注册等接口;负责组织项目组完成设计开发过程中的全部文件工作;市场人员负责市场调研,用户需求等,和反馈市场信息;建立医生和研发之间的 桥梁,协助临床评价;保持相关记录;完成相关的文件化工作。Marketing personnel is in charge of market research andfeedback of market information,user needs and so on,build the bridge of R&D with doctor,assisting clinical evaluation,
11、and dealing with the affairs of products,maintaining the particular records;establishing the documents.项目组成员职位及职责描述研发工程师负责医疗器械及其部件的产品设计和工艺设计等(包括包装、标签、说明书)的设计;负责原材料选择、工夹具、仪器设备的选择,样品研制;设计验证,确认;负责组织研发和工艺过程风险管理和试生产活动,参与过程确认和过 程控制;并与QA一起完成验证和过程确认;负责保持详细的相关记录;负责制造工艺的培训和相关的文件化工作。R&D engineer is in charge o
12、f design of the medical device and its parts(including packaging,labeling and instruction for use),selection the raw materials,implements,instruments,research of technique,sample products manufacturing;arranging design transfer and risk management in the process of manufacturing;assisting QA in veri
13、fication and process validation,maintaining the particular records,technical training.and documenting works;项目组成员职位及职责描述质量工程师QA研发阶段产品质量控制和生产过程中的质量控制,起草研发过程中的 质量文件,包括过程检验点检测内容及标准,产品标准;工作切入点:协助研发工程师和工艺工程师进行风险分析;设计输入阶段负责组织特殊过程和关键工序的确认;负责产品监视和测量设备校准;负责供应商质量管控和供应商评价;负责QC人员的培训;鉴定产品测试方法;负责保持详细的相关记录;负责完成相关的
14、文件化工作。QA engineer is in charge of quality action of all the procedureof R&D and production.Make the quality document in theprocesses.Perform risk analysis together with R&D engineersand manufacture engineers.Evaluate suppliers and verify thematerials.packaging sterilization arranging the validation
15、ofspecial processes,establishing planning and regulation ofmonitoring and measurement of product;in charge of trainingof product inspection,and test method for product,maintaining the particular records;establishing the documents.项目组成员职位及职责描述工艺工程师 工作切入点:样品评审 设备工程师工艺工程师:负责配合研发工程师组织生产人员培训,负责组织工艺过程风险管理
16、和试生产活动,参与过程确认和过程控制,负责保持详细的相关记录;负责完成相关的文件化工作。设备工程师:参与设计转移活动,负责等。设备编号、安装确认、编制 设备操作文件、制定设备维护规程Manufacture engineers has the responsibility assisting R&D engineers in training operators,arranging design transferring and risk management in the process of manufacturing;take part in process verification and process validation;maintain the particular records and establish the documents.Equipment engineer take part in the process of design transfer;in charge of series number of equipment,installation qua
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