Medical network - on August 17, August 15, the CFDA medical instrument technical review center issued this year 4, the medical device is preferred for examination and approval of application verification result of the public, with a total of three products fitting for prior approval. Specific include:
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产品名称
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申请人
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同意理由
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疝修补片
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北京博辉瑞进生物科技有限公司
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列入国家重点研发计划
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胸主动脉覆膜支架系统
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北京华脉泰科医疗器械有限公司
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列入国家重点研发计划
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基因测序仪
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武汉华大智造科技有限公司
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列入国家重点研发计划
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It is reported that this year, the center has issued priority approval notice no. 3 this year, only 6 medical device products received priority approval, including:
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产品名称
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申请人
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同意理由
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药物洗脱球囊导管
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辽宁垠艺生物科技股份有限公司
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临床急需，且在我国尚无同品种产品获准注册的医疗器械。（可用于冠脉分叉病变）
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血液透析/滤过装置
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广州市暨华医疗器械有限公司
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列入国家重点研发计划
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中空纤维膜血液透析滤过器
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成都欧赛医疗器械有限公司
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列入国家重点研发计划
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Released by CFDA last October 25, the medical instrument prior approval process, to meet the following conditions within the territory of one of the third class and import for the second and third class medical device registration approval implementation of priority:
(a) comply with any of the following circumstances medical devices:
1. Diagnosis or treatment of rare diseases with obvious clinical advantages;
2. Diagnosis or treatment of malignant tumor with obvious clinical advantages;
3. Diagnosis or treatment of elderly persons with specific and multiple diseases, and there is no effective diagnosis or treatment;
4. Special for children, with obvious clinical advantages;
5. Clinical needs are urgently needed, and there are no medical instruments licensed for registration in our country.
(2) medical devices listed in national science and technology major special projects or state key research and development plans.
(3) other medical devices that shall be subject to approval.
From the above six priorities for examination and approval of medical equipment products, you can see, there are five products because "included in the national key research and development" and to obtain prior approval, only a product because of clinical need to obtain prior approval.
For the approved companies, the pace of product launch will be greatly accelerated.
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