医疗器械
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近期，药监局发布了软性接触镜及人类体外辅助生殖技术液注册技术审查指导原则。
本指导原则所涉及的软性接触镜是指采用光学矫正原理，以矫正近视、远视、散光为目的的产品。特殊设计或采用新材料的软性接触镜产品需结合申报产品自身特点增加要求，同时参考本指导原则。
本指导原则适用于按照医疗器械管理的人类体外辅助生殖技术用液。人类体外辅助生殖技术用液是指与人类配子和/或胚胎发生直接或间接接触，以准备、培养、转移或存储人类配子和/或胚胎的液体类医疗器械产品，如：取卵液、卵子与胚胎处理液、精子洗涤液、精子密度梯度分离液、精子制动液、体外受精液、卵裂胚培养液、囊胚培养液、配子/胚胎冷冻液、配子/胚胎解冻液、培养用油等。
扫描下方的二维码订阅“ CIRS医械合规动态 ”！实时传递最新医疗器械监管法规动态，分享医疗器械注册成功经验及经典案例跟踪医疗器械最新产品安全与法规监管动态，获得最新一手资讯。
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