ku1314520 回复了问题 2023-09-17 22:13

医疗器械技术评审

问答 could the software information in the devicecertificate be updated during Registration Renewal?

ku1314520: Active medical devices and the cooperated softwareare independent medical devices, each with its own registrationcertificate, and the version of the c...

赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 回复了问题 2023-09-17 22:12

医疗器械技术评审

问答 If medical device software is updated, when willit need to submit Change of Permission Items?

ku1314520: First. manufacture should justify weather the update isconsidered as major update or minor update according to theGuidance for technical review of med...

赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 回复了问题 2023-09-17 22:11

医疗器械技术评审

问答 How to determine the naming rules for softwareversion?

ku1314520: The software version is used to identify the software statusand to control the software update. The naming rule of softwareversion is decided during t...

赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 回复了问题 2023-09-17 22:10

医疗器械技术评审

问答 What is software core algorithm?

ku1314520: Software core algorithm refers to the algorithm necessaryto realize the software core function (the function necessary for thesoftware to complete the...

赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 回复了问题 2023-09-17 22:07

医疗器械技术评审

问答 What should be included in the research data ofactive medical devices service life?

ku1314520: The administrative counterparts shall submit an analysis ancevaluation report on the service life of the product. The report shallspecify the evaluati...

赞同0 反对 0 人感谢 0 评论 1 回复

ku13145 回复了问题 2023-09-17 16:50

医疗器械技术评审

问答 How to determine the service life of active medicaldevices?

ku13145: The manufacturer should dynamically evaluate the servicelife of the product through risk analysis in the whole life cycle of theproduct. When there is...

赞同0 反对 0 人感谢 0 评论 1 回复

ku13145 回复了问题 2023-09-17 16:49

医疗器械技术评审

问答 How to determine the productcategory and classification code?

ku13145: There are many cases of combination products in activemedical devices.One product contains two independent functionalmodules, and each module belongs ...

赞同0 反对 0 人感谢 0 评论 1 回复

ku13145 回复了问题 2023-09-17 16:47

医疗器械技术评审

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

ku13145: 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 requirement...

赞同0 反对 0 人感谢 0 评论 1 回复

ku13145 回复了问题 2023-09-17 16:46

医疗器械技术评审

问答 What are the requirements for adding models oraccessories in the Change of Permission Items?

ku13145: The contents contained in one registration certificate shallcomply with the requirements of“Guidance of registration unitsdivision for medical device”...

赞同0 反对 0 人感谢 0 评论 1 回复

ku13145 回复了问题 2023-09-17 16:45

医疗器械技术评审

问答 the question abaot of non-medical device components?

ku13145:  For the non-medical device components, they are not allowedto be submitted separately, but can be submitted as components ofmedical devices.If t...

赞同0 反对 0 人感谢 0 评论 1 回复

ku13145 回复了问题 2023-09-17 16:38

医疗器械技术评审

问答 is it possible to register thehost and consumables together in the name of company A?

ku13145: (1) If the consumables of company B act on human body in aninvasive way, it is recommended to register separately.(2) If the consumables of company B ...

赞同0 反对 0 人感谢 0 评论 1 回复

ku13145 回复了问题 2023-09-17 16:37

医疗器械技术评审

问答 butonly part of the configurations was selected when submittedin China. Will it be accepted?

ku13145: When imported medical devices is submitted registrationin China, the scope of application of the medical device shall notexceed the scope when approve...

赞同0 反对 0 人感谢 0 评论 1 回复

qwe123123 回复了问题 2023-09-17 16:29

医疗器械技术评审

问答 如何准备PDF版注册申报资料?

qwe123123: 建议尽可能使用由源文件(如 WORD/WPS 文件)转化形成的PDF文件，例如WORD文件可通过另存为 PDF 格式实现转化。若注册申报资料中含有无法访问电子来源文件或需要第二方签章的文件，此部分资料可以提交经扫描纸质文件后创建的PDF文件。

赞同0 反对 0 人感谢 0 评论 1 回复

qwe123123 回复了问题 2023-09-17 16:28

医疗器械技术评审

问答 通过eRPS 系统进行电子申报的事项如何查询 申报进度?

qwe123123: 在既有的进度查询方式的基础上，通过eRPS 系统进行电子申报的事项，该事项申请表中填写的联系人可收到短信和邮件的状态更新提醒，另外企业用户还可以登录 eRPS 系统查看该项目的状态是否有更新。

赞同0 反对 0 人感谢 0 评论 1 回复

小懒虫 回复了问题 2023-09-17 16:27

医疗器械 医疗器械技术评审

问答 eRPS系统中用户名+密码登录方式和数字证书+密码登录方式的区别是什么?

小懒虫: eRPS 系统引入数字证书的登录方式是为了保证注册电子申报的用户认证的唯一性和资料传输的安全性。用户名 + 密码的登录方式可以实现电子申报事项的线下途径提交和暂未开通电子申报事项(注册证及变更文件的补办、纠错、自行注销、自行撤回，医疗器械注册指定检验)的申报:数字证书+密码的登录方式可以实现电子申报...

赞同0 反对 0 人感谢 0 评论 1 回复