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si4520 在 2023-09-18 20:50 回答了问题 医疗器械技术评审: the interests in the review of metallicpowder materials for additive？; si4520: The technical review of metallic powder materials foradditive manufacturing in dentistry mainly focus on three aspects:the performance requirements of...; 赞同0 反对 0 人感谢 0 评论 1 回复

si4520 在 2023-09-18 20:47 回答了问题 医疗器械技术评审: study report ofthe same kind or similar products be submitted?; si4520: It is recommended to submit the extraction study report forthe product under application, clarifying the extraction method and the basis for determini...; 赞同0 反对 0 人感谢 0 评论 1 回复

si4520 在 2023-09-18 20:06 回答了问题 医疗器械技术评审: the mode of connection dentalimplant and abutment fall under product structure andcomponents?; si4520: Yes. The mode of connection between dental implant andabutment is among the contents that should be specified in theproduct structure and components. ...; 赞同0 反对 0 人感谢 0 评论 1 回复

si4520 在 2023-09-18 20:01 回答了问题 医疗器械技术评审: changingthe center thickness of soft contact lenses?; si4520: Yes. The oxygen permeation properties of soft contactlenses include two indexes: oxygen permeability Dk and oxygentransmissibility Dk/t, and the latte...; 赞同0 反对 0 人感谢 0 评论 1 回复

si4520 在 2023-09-18 19:59 回答了问题 医疗器械技术评审: multiple receiving coils inMRI system are used jointly?; si4520: In the case of joint use of multiple receiving coils in the MRIsystem, the following issues shall be considered in the registrationsubmission:(1) The ...; 赞同0 反对 0 人感谢 0 评论 1 回复

si4520 在 2023-09-18 19:57 回答了问题 医疗器械技术评审: how to provide the CT related overview material andresearch data?; si4520: When applying for registration of PET/CT products, whenCT has obtained a separate registration certificate, the overviewmaterial and research data of ...; 赞同0 反对 0 人感谢 0 评论 1 回复

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