重组胶原蛋白“械三证”激战正酣,下一个获批者会是谁?

生物科技馆
Sep 21, 2025

“械三证”领域的竞争正愈发激烈。“械三证”,作为我国针对高风险医疗器械产品设立的严格准入门槛,涵盖了注射填充剂、射频设备等核心医美产品类别。对于企业而言,获取“械三证”不仅审批流程繁琐,而且需要巨大的研发投入。由于“械三证”技术门槛高、市场独占优势显著,它已成为推动企业业绩增长的关键因素。特别是在重组胶原蛋白领域,“械三证”的价值愈发凸显。截至目前,在医美行业,我国仅有的3张重组人源化胶原蛋白三类...

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