中国医疗器械行业发展报告（2024）
中文摘要
本书立足于2023年我国医疗器械行业的发展现状，分总报告、政策篇、行业篇、区域篇、实践篇、借鉴篇、附录七个部分，共包括34篇报告。用翔实的资料、数据、图表阐述了行业发展状况，指出了行业发展中存在的不足及面临的挑战，对我国医疗器械行业发展的未来进行了预判，并给出了建议或解决方案。
2023年，国家药品监督管理局持续深化医疗器械审评审批制度改革，突出加强全生命周期质量监管，稳步推进医疗器械安全巩固提升行动，大力加强监管体系和能力建设，全力助推产业创新和高质量发展，医疗器械安全形势持续稳定、积极向好，有力地保障了人民群众用械安全有效。
截止到2023年底，我国医疗器械生产企业总数为32313家，比上一年减少了319家；我国医疗器械行业生产企业主营业务收入约11600亿元，比上一年下降约6.4%，这种情况在21世纪以来的20多年中是首次出现。主要原因有三个：一是2023年防疫类医疗器械市场需求大幅度下降；二是国家医用耗材集中带量采购持续推进，产品价格继续下降；三是国家加大医疗领域反腐力度在一定程度上影响了医疗器械市场的活动。2023年底，我国医疗器械经营企业总数为1375709家，比上一年增加166010家。
2023年，国家药品监督管理局共批准上市创新医疗器械产品61个，比上一年增加6个，增长10.9%；至2023年底，获批上市创新医疗器械产品达到250个，过去十年整体保持增长趋势。2023年，我国医疗器械企业研发投入比重增加，全国117家A股上市医疗器械公司研发投入经费总额为225.18亿元，占年度营业收入总额的8.99%，比2022年有所提高。
2023年，我国医疗器械进出口总额为778.18亿美元，比上年的858.41亿美元减少80.23亿美元，下降9.35%。其中，进口402.44亿美元，比上年减少7.71亿美元，下降1.88%；出口375.74亿美元，比上年减少72.52亿美元，下降16.18%。进出口总额的下降主要与防疫类医疗器械出口需求大幅下降有关。
未来我国医疗器械行业将继续保持稳定的发展速度，医疗器械产品的总体质量将稳步提高，创新医疗器械将加速涌现，一些高端医疗器械的关键核心技术和关键零配件研发将取得新突破，公众用械安全有效将得到更有力的保障，我国医疗器械行业仍然处于“黄金发展期”。
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