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小懒虫在 2023-09-17 22:23 发起了提问 医疗器械技术评审: 问答 How to select EMC test samples?

ku1314520: If there are multiple models and accessories in theapplication registration unit of active medical devices, theadministrative counterparts shall take ...; 关注问题 1  0  0 评论

小懒虫在 2023-09-17 22:21 发起了提问 医疗器械技术评审: 问答 Is it necessary to associate EMC test report withelectrical safety test report?

ku1314520: During product registration and changing registration, EMCtest report and electrical safety test report shall be related to ensurethat the electrical ...; 关注问题 1  0  0 评论

小懒虫在 2023-09-17 22:20 发起了提问 医疗器械技术评审: 问答 the sproduct mode andspecification and instruction for division%?

ku1314520: According to“Guidance for Product Technical Requirementof medical device”, the product model and/or specifications shallbe clearly defined in the Prod...; 关注问题 1  0  0 评论

小懒虫在 2023-09-17 22:18 发起了提问 医疗器械技术评审: 问答 how to describe the computer in the productregistration?

ku1314520: If the active medical device is used with a general-purposecomputer, the computer may not be an composition components ofthe product, but the requirem...; 关注问题 1  0  0 评论

小懒虫在 2023-09-17 22:17 发起了提问 医疗器械技术评审: 问答 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...; 关注问题 1  0  0 评论

小懒虫在 2023-09-17 22:16 发起了提问 医疗器械技术评审: 问答 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...; 关注问题 1  0  0 评论

小懒虫在 2023-09-17 22:14 发起了提问 医疗器械技术评审: 问答 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...; 关注问题 1  0  0 评论

小懒虫在 2023-09-17 22:13 发起了提问 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...; 关注问题 1  0  0 评论

小懒虫在 2023-09-17 22:11 发起了提问 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...; 关注问题 1  0  0 评论

小懒虫在 2023-09-17 22:10 发起了提问 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...; 关注问题 1  0  0 评论

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