·医疗卫生装备·2023年1月第44卷第1期ChineseMedicalEquipmentJournal·Vol．44·No．1·January·2023生育力保存中玻璃化冷冻载杆的研究趋势及监管挑战张坤智，晁园，孙晓晴，俞卉，王越*，齐伟明*（浙江省医疗器械审评中心审评二科，杭州310009）[摘要]阐述了生育力保存过程中关键医疗器械玻璃化冷冻载杆的演化历程，分析了现有的“开放式冷冻、开放式保存”“开放式冷冻、封闭式保存”及“封闭式冷冻、封闭式保存”3种玻璃化冷冻载杆的优势与弊端，提出了玻璃化冷冻载杆的改良趋势并提供了研究思路，立足监管挑战剖析了玻璃化冷冻载杆监管关注点，为提升生育力保存的有效利用率及国产辅助生殖医疗器械的发展提供了助力。[关键词]生育力保存；玻璃化冷冻；玻璃化冷冻载杆；辅助生殖；卵母细胞保存[中国图书资料分类号]R318.6；TH789[文献标志码]A[文章编号]1003-8868（2023）01-0081-06DOI：10.19745/j.1003-8868.2023014ResearchtendencyandregulatorychallengeofvitrificationcryopreservationstrawsinfertilitypreservationZHANGKun-zhi,CHAOYuan,SUNXiao-qing,YUHui,WANGYue*,QIWei-ming*(No.2DepartmentofEvaluation,ZhejiangMedicalDeviceEvaluationCenter,Hangzhou310009,China)AbstractThedevelopmentofvitrificationcryopreservationstrawsinfertilitypreservationwaselaborated.Threekindsofvitrificationcryopreservationstrawsofopenfreezingwithopenpreservation,openfreezingwithclosedpreservationandclosedfreezingwithclosedpreservationwereanalyzedontheiradvantagesanddisadvantages.Theimprovementtrendsandresearchideaswereproposedforvitrificationcryopreservationstraws.Theissuesforsupervisingvitrificationcryopreservationstrawswereexploredinlightoftheregulatorychallenges.Theeffectiveutilizationoffertilitypreservationandassistedrepro-ductivedevicesinChinawerepromotedgreatly.[ChineseMedicalEquipmentJournal，2023，44（1）：81-86]Keywordspreservationoffertility;vitrificationfreezing;vitrificationcryopreservationstraw;assistedreproduction;oocytepreservation0引言生育力保存通常具体地指向女性的卵巢功能特别是卵母细胞质与量的保护及保存，而女性的卵母细胞对于生育而言属于“稀缺资源”，是人类生育力的瓶颈限制环节[1]。根据国内外生育力保存指南的建议，卵母细胞冷冻保存和胚胎冷冻...
