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ku1314520
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提问 17
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ku1314520
在 2023-09-17 22:47 回答了问题
医疗器械技术评审
If separately registered, do theyhave to clarify the matching situation?
ku1314520
:
The generator and surgical accessories of high frequencysurgical equipment can either be submitted registration as the wholeproduct, or separately.Hig...
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ku1314520
在 2023-09-17 22:45 回答了问题
医疗器械技术评审
the transducer and surgicalinstruments can be connected into other manufacturesmain engine?
ku1314520
:
The compatibility of main engine, transducer and surgicalinstruments of ultrasound soft tissue surgical equipment will havegreat influence on the prod...
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ku1314520
在 2023-09-17 22:44 回答了问题
医疗器械技术评审
what aspects should beconsideredin the application materials?
ku1314520
:
For large-scale imaging equipment (such as CT,MRPET/CT,etc.), if the third-party physiological gating interface isprovided, such as respiratory gating...
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ku1314520
在 2023-09-17 22:42 回答了问题
医疗器械技术评审
Do we need the control groupin the animal experiment?
ku1314520
:
The animal experiment mainly provides evidence for thefinalization of product design, provides the evidence for the medicaldevice to enter the clinica...
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ku1314520
在 2023-09-17 22:40 回答了问题
医疗器械技术评审
medical X-ray diagnostic equipment ( ClassIII)?
ku1314520
:
Please refer to the“Guidance for product registrationtechnical review of medical X-ray diagnostic equipment (Class Il ”Clinical parts usually include ...
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ku1314520
在 2023-09-17 22:39 回答了问题
医疗器械技术评审
predicate medical device in clinicalevaluation?
ku1314520
:
Software difference may cause difference in productperformances,clinical functions and core algorithms. Accordingto the“Guidance for clinical evaluati...
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ku1314520
在 2023-09-17 22:37 回答了问题
医疗器械技术评审
can we onlycompare the key performances?
ku1314520
:
Comparison with predicate medical device in clinicalevaluation for active medical device, what content to be comparedis relevant to the product featur...
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ku1314520
在 2023-09-17 22:36 回答了问题
医疗器械技术评审
Under what circumstances do environmentatests need to be carried out on medical electricalequipment?
ku1314520
:
If the medical electrical equipment is expected to be used ina special environment (such as high temperature, high humidity orlow temperature), or if ...
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ku1314520
在 2023-09-17 22:35 回答了问题
医疗器械技术评审
When submit Change of Permission Items foradding models, is it necessary for type testing?
ku1314520
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First, it is necessary to identify whether the adding modelscan be regarded as the same registration unit with the originalmodels. If so, application ...
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ku1314520
在 2023-09-17 22:34 回答了问题
医疗器械技术评审
can theelectrical safety and electromagnetic compatibility test beexempted?
ku1314520
:
The change of the shell structure and the overall sealingperformance of the equipment may lead to the change of theelectrical safety and electromagnet...
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