la4778 回复了问题 2023-09-18 13:40

医疗器械技术评审

问答 心电图机变更注册中如检验机构尚未获得GB 9706.225-2021标准的检验资质，是否认可其出具的检验报告？

la4778: 按照《医疗器械监督管理条例》第七十五条规定，医疗器械检验机构资质认定工作按照国家有关规定实行统一管理。经国务院认证认可监督管理部门会同国务院药品监督管理部门认定的检验机构，方可对医疗器械实施检验。由于心电图机所对应的GB 9706.225-2021《医用电气设备 第2-25部分：心电图机的基本安全和...

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la4778 回复了问题 2023-09-18 13:36

医疗器械技术评审

问答 注册申请人与受托生产企业签订的医疗器械委托生产质量协议应包括哪些内容？

la4778: 注册申请人应当与受托生产企业签订委托协议，明确双方权利、义务和责任，协议至少应当包括受托生产企业的生产条件、技术文件的转移、物料采购控制、生产工艺和过程控制、成品检验、产品放行控制、文件与记录控制、变更控制、质量管理体系审核等，确保受托生产企业按照法律法规、医疗器械生产质量管理规范、强制性标准、产品...

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la4778 回复了问题 2023-09-18 13:33

医疗器械技术评审

问答 注册申请人委托具备相应条件的企业生产医疗器械，委托方对受托方质量管理体系进行审核时应关注哪些内容？

la4778: 委托生产前，注册申请人应当对受托生产企业的质量管理体系开展现场评估审核，审核内容至少应当包括机构和人员、厂房与设施、设备、生产管理、质量控制能力等，确保受托生产企业具备与受托生产产品相适应的质量管理体系。

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la4778 回复了问题 2023-09-18 13:31

医疗器械技术评审

问答 医疗器械工艺验证，例清洗残留验证的检验，一定要委托第三方有资质（CNAS）检验吗，对资质这一块有明确要求吗（法规未查到有这一方面的规定）？

la4778: 医疗器械工艺验证作为产品设计开发到生产转换的重要活动，其验证检验结果的可靠性直接关系到产品生产工艺的分析改进、工艺参数确定的科学合理性，以及最终输出的工艺规程能否充分指导生产出质量持续稳定产品。清洗方法效果验证工作中，清洗残留的检验是关键，检验方法的有效性确认更是决定验证工作成败的关键，因此，鼓励注...

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ku1314520 回复了问题 2023-09-17 22:47

医疗器械技术评审

问答 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 回复了问题 2023-09-17 22:45

医疗器械技术评审

问答 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 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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