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辅助生殖用取卵针和胚胎移植导管产品监管现状和注册申报要求 预览

Supervised Status and Registration Requirements for the Rroducts of Follicle Aspiration Needles and Embryo Transfer Catheters for Assisted Reproduction
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摘要 辅助生殖技术(Assisted Reproductive Technology,ART)是治疗不孕不育的有效手段,ART所用医疗器械的有效性和安全性不仅直接影响患者本身,更重要的是有可能影响子代的发育和健康。文章简述国内外监管现状并详述ART用耗材类医疗器械取卵针和胚胎移植导管产品的注册申报要求。 Assisted reporductive technology(ART)is an effective treatment of infertility.The effectiveness and safety of medical devices used on ART not only affects infertility patients,more importantly,it may affects the development and health of the offspring.In this paper,the supervised status at home and abroad is summarized,and the registration requirements of the consumable medical devices of follicle aspiration needles and embryo transfer catheters for ART are detailed.
作者 邹艳果 许耘 ZOU Yan-guo;XU Yun(Center for Medical Device Evaluation,NMPA,Beijing 100081)
出处 《中国医疗器械信息》 2019年第9期1-3,共3页 China Association for Medical Devices Industry
关键词 辅助生殖技术 医疗器械 注册 监管 assisted reporductive technology medical device registration supervision
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