2026年开年,翱锐生物、堃博医疗等多款创新器械进入特别审查通道

制药网
Jan 14

近年来,在政策、市场、技术、资本四轮驱动下,中国创新医疗器械产业正快速发展。2025年,国产高端医疗器械就已迎来丰收年,并呈现出高端替代与全球创新并行趋势。具体来看,去年创新器械获批 76 个;其中在12月,国家药监局和地方药监局就公示了31款器械进入创新医疗器械特别审查通道。当下,国内创新医疗器械审评审批效率还在持续提升,这不断激发着企业的创新活力。在此背景下,2026年以来,又有大批国产...

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