中国医疗器械行业发展报告（2021）
中文摘要
中国医疗器械行业在国家政策的引导下，近年来保持着健康高速发展的良好态势。2020年面对突如其来的新冠肺炎疫情，医疗器械行业及时提供了大量诊断试剂、呼吸机、防护服、防护口罩等防护用品，发挥了不可替代的重要作用。
本书首先对我国医疗器械行业2020年的政策法规、审评审批、生产经营、进出口等方面的情况进行了总结，分析了我国医疗器械行业面临的挑战，并对未来进行了预判。未来两年我国医疗器械行业面临的机遇远大于挑战，市场将进一步扩大，并继续保持较高速度的发展；创新医疗器械将加速涌现；企业的兼并联合重组将增多，我国医疗器械行业仍然处于“黄金发展期”。其次，重点阐述了2020年国家医疗器械审批制度的改革进展与应急医疗器械的审批、医疗器械的不良反应检测、经营监管情况，梳理归纳了医用耗材集中采购的发展趋势，提出应全面推进落实医疗器械唯一标识制度，全力推进医疗器械高质量监管，加强医疗器械不良事件监测，及时处置产品风险，努力保障医疗器械安全有效。对外贸易方面，我国医疗器械产品的出口成绩亮眼，对中国外贸的整体表现贡献突出；进口受疫情的负面影响较大，增速放缓。针对体外诊断原料市场、分子诊断行业、骨科植入物行业、心脏瓣膜器械行业、导尿管行业、角膜病相关手术和植入器械、手术机器人产业及可穿戴式医疗器械等部分细分领域进行了全面的概述，梳理了上海、江西、福建、宁夏、辽宁五个省（区、市）的医疗器械行业的发展现状、先进举措，针对它们未来的发展趋势等进行了分析。最后，本书分析了医疗器械行业在应对新冠肺炎疫情中的工作、产品、服务等情况，以及医疗器械行业的部分典型事例。
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