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ku1314520 在 2023-09-17 22:17 回答了问题 医疗器械技术评审: is it not applicable to the cybersecurityrequirement?; ku1314520: The applicability of cybersecurity for medical device refersto not only the network connection for electronic data transfer andremote control, but als...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:16 回答了问题 医疗器械技术评审: Can the cybersecurity descriptiondocument be submitted within the software descriptiondocument?; ku1314520: The“Guidance for premarket review for medical devicescybersecurity”is applicable to the registration and applicationof Class I and Class Il medical de...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:15 回答了问题 医疗器械技术评审: If the Android APP is registered, isit necessary to be tested when adding iOS APP?; ku1314520: Android and iOS are incompatible operating systemplatforms. To add iOS Apps across platforms, it is necessary to betested with the host, and submit th...; 赞同0 反对 0 人感谢 0 评论 1 回复

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 23:09 发起了提问 医疗器械技术评审: 问答产品的适用范围是否一定与临床评价同品种完全一致？

xbs999: 需要实质性等同。; 关注问题 1  0  0 评论

ku1314520 在 2023-08-30 23:08 发起了提问 医疗器械技术评审: 问答根据《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？

xbs999: 依据《定制式义齿注册技术审查指导原则》的要求，定制式固定义齿的主要性能指标包括：义齿的制作，应使用具有医疗器械注册证书的齿科烤瓷合金、齿科铸造合金、瓷粉、瓷块、复合树脂、铸造蜡、铸造包埋材料及其他按医疗器械管理的产品。定制式固定义齿的原材料要求应在技术要求中的性能要求中做出明确规定。; 关注问题 1  0  0 评论

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