doesthe original model need to be implemented with the newstandard requirements? - 分享质量人的知识和经验

登录

1: 关注

1055: 浏览

doesthe original model need to be implemented with the newstandard requirements?

医疗器械技术评审

If Change of Permission Items indicates addingof models, meanwhile new standards are involved,doesthe original model need to be implemented with the newstandard requirements?

好问题 0 评论收藏举报

您还未登录!暂时最多只可查看 1 条回答

去登录! 还没有账号?去注册

1 回答

ku13145 二阶会员用户来自于: 广东省深圳市
2023-09-17 16:47

For instance, the registered models are A and B,and thenew models are C and D. Then, for the new models, they shall beimplemented with the requirements of the new standard, and thetesting report and/or verification/validation data shall be providedIf the original models A and B are not changed, then no relevantinformation is needed and new standard is not added into the ProductTechnical Requirements. Administrative counterparts shall ensurethat A and B can also meet the requirements of the new standardfrom the date of implementation of the new standard.If new standard is added into the Product TechnicalRequirements, testing reports and/or verification/validation data shallbe submitted to certify A and B could meet the modified ProductTechnical Requirements.

赞同 0 0评论

关于作者

: cyxwvoarn 二阶会员
这家伙很懒，还没有设置简介

33: 回答

20: 文章

922: 问题

问题动态

发布时间: 2023-09-17 16:47

更新时间: 2023-09-17 16:47

关注人数: 1 人关注

相关问题

Medical endoscopes have several models, how tochoose the typical model for type test?: 895 浏览 1 关注 1 回答 0 评论

Under what circumstances do environmentatests need to be carried out on medical electricalequipment?: 896 浏览 1 关注 1 回答 0 评论

What are the requirements for adding models oraccessories in the Change of Permission Items?: 997 浏览 1 关注 1 回答 0 评论

When submit Change of Permission Items foradding models, is it necessary for type testing?: 1095 浏览 1 关注 1 回答 0 评论

If medical device software is updated, when willit need to submit Change of Permission Items?: 893 浏览 1 关注 1 回答 0 评论

Is it acceptable to save paper printed records instead of original electronic records?: 794 浏览 1 关注 1 回答 0 评论

Do medical optical endoscope and laser fiberoptics need to be tested for EMC?: 884 浏览 1 关注 1 回答 0 评论

Does each CGMP workflow on a computer system need to be validated?: 706 浏览 1 关注 1 回答 0 评论

Do we need the control groupin the animal experiment?: 1032 浏览 1 关注 1 回答 0 评论

Do wireless accessories of the active medicaldevices need to be tested during the EMC test?: 794 浏览 1 关注 1 回答 0 评论

推荐内容

问一次性使用真空采血管，如何验证其货架有效期？: 1030 浏览 1 关注 1 回答 0 评论

问柠檬酸消毒液的性能研究有哪些？: 1002 浏览 1 关注 1 回答 0 评论

问基台类产品进行临床评价时，如申报产品材质为合金(Ti6A4V )，是否可以选择纯材质(TA4)产品作为同品种医疗器械进行比对?: 990 浏览 1 关注 1 回答 0 评论

问体外辅助生殖用耗材(体外辅助生殖用液除外产品需要进行鼠胚试验吗?: 797 浏览 1 关注 1 回答 0 评论

问根据《医疗器械产品技术要求编写指导原则》的要求，产品的原材料要求应放在附录中，定制式固定义齿的原材料要求还要在技术要求的性能要求中吗？: 970 浏览 1 关注 1 回答 0 评论

问用于手术后体液引流的引流管产品，由不锈钢的穿刺针和硅胶的引流管组成，在进行生物相容性实验时，是必须对成品进行生物学检测，或是需要对硅胶管检测，或有硅胶材料本身的生物相容性报告即可?: 926 浏览 1 关注 1 回答 0 评论

问弹力包扎敷料的技术要求的性能指标制定只参考YY/T 1467-2016 《医用包扎敷料救护绷带》标准制定可以吗？: 961 浏览 1 关注 1 回答 0 评论

问体外诊断试剂临床试验使用的试剂批次有何要求?: 646 浏览 1 关注 1 回答 0 评论

问中频治疗仪产品中，通过按键控制强度、温度、时间等参数，通过液晶显示屏显示参数的简单的控制程序是否算是软件？如果是软件应当算什么类别，是否需要对其进行检测？: 157 浏览 1 关注 1 回答 0 评论

问创新医疗器械检验项目实验室无法进行检测怎么办？: 963 浏览 1 关注 1 回答 0 评论

技术支持 WeCenter © 2024 粤ICP备2023143277号-1