ku1314520 回复了问题 2023-09-17 22:44

医疗器械技术评审

问答 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 回复了问题 2023-09-17 22:42

医疗器械技术评审

问答 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 回复了问题 2023-09-17 22:40

医疗器械技术评审

问答 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 回复了问题 2023-09-17 22:39

医疗器械技术评审

问答 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 回复了问题 2023-09-17 22:37

医疗器械技术评审

问答 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 回复了问题 2023-09-17 22:36

医疗器械技术评审

问答 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 回复了问题 2023-09-17 22:35

医疗器械技术评审

问答 When submit Change of Permission Items foradding models, is it necessary for type testing?

ku1314520: 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 回复了问题 2023-09-17 22:34

医疗器械技术评审

问答 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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ku1314520 回复了问题 2023-09-17 22:32

医疗器械技术评审

问答 Medical endoscopes have several models, how tochoose the typical model for type test?

ku1314520: Generally, the following factors should be taken into accountin the selection of typical endoscopes in one registration unit:For endoscopes with diffe...

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ku1314520 回复了问题 2023-09-17 22:31

医疗器械技术评审

问答 Do medical optical endoscope and laser fiberoptics need to be tested for EMC?

ku1314520: Both medical optical endoscope and laser fiber opticsbelongs to the applied part of medical electric equipment. They don'have main supply connection. ...

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ku1314520 回复了问题 2023-09-17 22:30

医疗器械技术评审

问答 Do wireless accessories of the active medicaldevices need to be tested during the EMC test?

ku1314520: Whether the active medical device accessories need to betested for EMC has nothing to do with the connection form of theproduct, which mainly depends ...

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ku1314520 回复了问题 2023-09-17 22:27

医疗器械技术评审

问答 How to choose the operation mode in EMC test?

ku1314520:  The maximum emission operating mode shall be identifiedThe operation mode shall comprehensively and detailedly identifythe “function”described i...

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ku1314520 回复了问题 2023-09-17 22:26

医疗器械技术评审

问答 How to determine the essential performance ofimmunity test in EMC test of active medical devices?

ku1314520: “Essential performance’ refers to the achievement ofperformance of a clinical function, other than that related to BASICSAFETY, where loss or degradat...

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ku1314520 回复了问题 2023-09-17 22:24

医疗器械技术评审

问答 Is it necessary for EMC test together withinactive accessories in product composition?

ku1314520:  In general, equipment and devices used in EMC test, cablelayout and accessories in typical configuration shall be consistentwith those in normal...

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ku1314520 回复了问题 2023-09-17 22:23

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 ...

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