中国医疗器械行业发展报告（2022）
| 书 名： |
中国医疗器械行业发展报告（2022） |
| 英 文 名： |
ANNUAL REPORT ON THE DEVELOPMENT OF MEDICAL DEVICE INDUSTRY IN CHINA （2022）
|
| 作 者： |
王宝亭 耿鸿武 主编; 于清明 蒋海洪 李强 副主编 |
| I S B N： |
978-7-5228-0172-8 |
| 丛 书 名： |
|
| 关 键 词： |
医疗器械 行业监管 风险防控 |
| 出版时间： |
2022年07月 |
中文摘要
中国医疗器械行业面对近年来的疫情冲击，在国家政策的引导下，持续保持着健康高速发展的良好态势，面临的机遇依然大于挑战，仍然处在“黄金发展期”内。未来十年之内，我国医疗器械行业将继续保持健康快速发展的良好势头。2021年行业规模破万亿元，增长率约为17%，成绩骄人。
本书用翔实的资料、数据阐述了2021年我国医疗器械行业发展状况，指出了行业发展中存在的不足及挑战，对我国医疗器械行业发展的未来进行了预判，并给出了建议或相关解决方案。报告共分6个部分，33篇报告和1个附录。总报告，对我国医疗器械行业2021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，指出未来两年我国医疗器械行业面临的机遇远大于挑战，市场规模将进一步扩大，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”。政策篇，包括9篇报告，针对2021年我国医疗器械审评审批制度改革进展、医疗器械注册自检管理、医疗器械上市后监管、医疗器械不良事件监测、医用耗材集中采购、医疗机构大型医用设备配置管理、医疗器械风险管理标准、医疗器械临床试验及整体行业政策文件出台的情况进行了分析和阐述。行业篇，包括9篇报告，多维度、有选择性地针对医疗器械行业的部分细分领域，如国际贸易、投融资及骨科耗材、体外膜肺氧合（人工膜肺）、气管导管、房颤与卒中相关医疗器械、质子放射治疗装置、人工耳蜗、透明质酸医疗器械等，从行业发展、市场现状、存在的问题、发展趋势等方面进行了全面的概述，部分报告还介绍了其他国家和地区相关医疗器械行业的发展状况。区域篇，包括7篇报告，选择了河南、湖南、山东、吉林和海南5个省份及宁波市、泰州市2个城市，对这些地区的医疗器械产业发展现状、存在的问题和面临的挑战、未来发展趋势等进行了论述。实践篇，选取了7篇报告，介绍了医疗器械科技成果转化实践中的风险控制措施、医疗机构医疗器械招标评标信息化系统建设和医疗器械使用质量评价实践、医疗器械经营企业质量管理和医疗器械经营企业在注册人制度下的转型实践及核医学影像设备、放疗技术等方面的技术突破和临床应用情况。附录部分对2021年我国药监系统出台的医疗器械行业重要法规文件进行了汇总。
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总报告
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政策篇
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行业篇
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区域篇
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实践篇
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附录
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