ku1314520 回复了问题 2023-09-17 22:20

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...

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ku1314520 回复了问题 2023-09-17 22:19

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...

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ku1314520 回复了问题 2023-09-17 22:17

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...

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ku1314520 回复了问题 2023-09-17 22:16

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...

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ku1314520 回复了问题 2023-09-17 22:15

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...

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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...

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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...

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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...

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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...

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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...

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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...

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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 ...

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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...

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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”...

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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...

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