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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...; 赞同0 反对 0 人感谢 0 评论 1 回复

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...; 赞同0 反对 0 人感谢 0 评论 1 回复

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...; 赞同0 反对 0 人感谢 0 评论 1 回复

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...; 赞同0 反对 0 人感谢 0 评论 1 回复

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 ...; 赞同0 反对 0 人感谢 0 评论 1 回复

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...; 赞同0 反对 0 人感谢 0 评论 1 回复

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...; 赞同0 反对 0 人感谢 0 评论 1 回复

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 ...; 赞同0 反对 0 人感谢 0 评论 1 回复

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: First, it is necessary to identify whether the adding modelscan be regarded as the same registration unit with the originalmodels. If so, application ...; 赞同0 反对 0 人感谢 0 评论 1 回复

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...; 赞同0 反对 0 人感谢 0 评论 1 回复

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