本文就眼表植入式修复医疗器械的产品状况、市场概况及在研产品发展趋势进行了调研分析,全面展现了眼前段植入式器械的行业发展状况。领扣型人工角膜的临床试验已在全国展开,疗效评价全部超过世界卫生组织的脱盲标准;生物结膜产品预计于2020年启动多中心临床研究;目前还没有一种组织工程角膜产品可完成产业化并获得国家药品监督管理局的临床应用许可,但国家对这一领域的研究相当重视。目前已获注册证的脱细胞角膜基质/植片生产企业主要有三家,用于眼表治疗的生物羊膜生产企业有两家。这些产品的生产企业作为三类长期植入式医疗器械的生产企业,只有结合自身特点,有效地建设与监管相适应的生产体系,提升质量把控水平,加强风险管理意识,才能走上持续稳健发展的道路。
<<In this paper,the product status,market profile and developing trend of the implant-in-the-eye device are investigated and analyzed,and the industry development situation of the implant-in-front device is fully demonstrated. The clinical trial of collar-and-button artificial cornea has been carried out all over the country,and the evaluation of curative effect has exceeded the standard of World Health Organization. Bio-conjunctival products are expected to start multi-center clinical research in 2020. At present,there is no tissue engineering cornea product that can be industrialized and obtained the clinical application license of the State Food and Drug Administration,but the research in this field is of great importance. At present,there are three major acellular corneal stroma/graft,and there are two biologic amniotic membrane manufacturers for ocular surface therapy. As a long-term implantable medical equipment manufacturer of Class Ⅲ,these production enterprises can only go on the road of sustained and steady development by combining their own characteristics,effectively building production systems suitable for supervision,improving quality control level and strengthening risk management consciousness.
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