中国医疗器械行业发展报告（2020）
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中文摘要
2019年，我国医疗器械行业在监管政策不断完善、市场竞争更加激烈、集中招标采购规模逐步扩大、国际市场复杂多变的情况下，继续保持了良好的发展势头，生产企业数量、主营业务收入、研发投入、进出口贸易等继续增长。全国药品监督管理部门深入推进医疗器械审评审批制度改革，持续加强医疗器械全生命周期严格监管，不断强化法规标准基础建设，各项工作取得新成效，有力地推动了我国医疗器械行业的健康快速发展。
本书从多角度论述了2019年影响医疗器械行业发展的政策变化态势。审批制度改革方面，提出要不断健全医疗器械标准管理体系、加强医疗器械分类管理与医疗器械检验检查能力等；医疗器械上市后监管方面，建议加快推进法规制度建设、全面推进风险会商、加强疫情防控医疗器械质量监管等；对2019年不良事件监测数据进行了分析与解释，并提出应通过对不良事件报告的积极收集、分析，有针对性地采取风险控制措施，降低产品风险；为更好地应对突发公共卫生事件，对我国医疗器械应急审批程序和相关法律要求进行了总结；审评制度改革方面，建议积极推进智慧审评、提高审评科研水平、有效运行审评科学管理体系等；在总结2019年典型省（区、市）、地市耗材集中采购特点的基础上，提出2020年国家集中采购将常态化，各省（区、市）将会利用省级集中采购平台广泛地进行带量采购；2019年医疗器械注册人制度试点范围进一步扩大，产业创新活力得到激发。
行业整体层面，提出2019年我国医疗器械对外贸易继续保持上升态势，全年进出口总额突破500亿美元，预计2020年将继续保持两位数的增长态势；剖析了医疗器械合规性、检验检测体系建设、临床试验质量等方面存在的问题，为行业健康发展提供了方向。行业细分层面，以医疗机器人、伴随诊断、骨科植入物行业为代表，理清了行业发展热点问题，对它们的未来发展趋势进行了预测。市场层面，对我国医用防护性物资、外科吻合器、左心耳封堵器、颅内脑电采集器械、眼前段手术植入器械的市场应用现状及前沿技术开发情况进行了总结，并对其未来发展路径进行了思考。区域层面，以北京、上海、广东、江苏、湖北、云南、内蒙古七个省（区、市）为代表，分析了省级层面医疗器械行业发展相关数据与政策，概括了不同地区医疗器械、临床设备配置的情况。实践层面，展现了深圳、邯郸促进医疗器械产业健康发展的创新实践，医疗器械注册人制度实际实施中企业所面临的责任风险与注册人的十大认知误区，医疗器械产业园综合实力评估办法，医疗器械CDMO新业态下第三方机构的参与机制等。
最后，在新冠肺炎疫情暴发背景下，本书对我国医疗器械供给保障制度和机制、应急医用物资保障体系进行了探讨，对即时检测（POCT）技术应用、医疗器械产品上市审批、ECMO应用等进展进行了思考。
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