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ku1314520 在 2023-09-17 22:13 回答了问题 医疗器械技术评审: 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 在 2023-09-17 22:12 回答了问题 医疗器械技术评审: 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 在 2023-09-17 22:11 回答了问题 医疗器械技术评审: 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 在 2023-09-17 22:10 回答了问题 医疗器械技术评审: 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 在 2023-09-17 22:07 回答了问题 医疗器械技术评审: 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

ku1314520 在 2023-08-30 22:59 回答了问题 医疗器械技术评审: 注册补充检验是否需要到原检验单位进行？; ku1314520: 如为2022年1月1日之前受理的需要到原检验单位进行补检，之后受理的不需要。; 赞同0 反对 0 人感谢 0 评论 1 回复

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