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双循环
2019年是医疗器械临床试验快速发展的一年。从监管层面看，国家药品监督管理局持续完善医疗器械临床试验相关法规体系，连续发布一系列医疗器械临床试验相关技术指导原则，强化临床试验各环节的监管，促使医疗器械注册申请及批准数量持续增加；从机构层面看，临床试验机构备案制正式实施，医疗器械临床试验机构数量激增，推进了医疗器械临床试验的开展；从质量层面看，申办方加大了对资金和人员的投入，医疗研究机构加强了对研究和管理人员的培训，临床试验的水平及质量得到一定程度的提升；从结果层面看，高质量临床试验推动更多的创新医疗器械产品上市，医疗器械领域的整体研发态势不断向好的方向快速发展。但仍存在真实性存疑和规范性不足等问题，未来仍然需要从强化项目监管、加强人员培训、加大各方投入等方面持续改进提升。
<<The year 2019 was a year of rapid development in clinical trials of medical devices. From the regulatory level，the State Drug Administration continues to improve the medical device clinical trials related regulations system，continuous release of a series of medical device clinical trials related technical guidelines，strengthen the supervision of clinical trials of various links，medical device registration applications and approval projects continued to increase；from the institutional level，with the formal implementation of clinical trials，medical device clinical trials，the number of clinical trials，the development of medical device clinical trials continued to increase；from the quality level of the overall development of investment in products and quality，medical device research and quality，medical device research and training. However，there are still some problems，such as the lack of authenticity and standardization，which need to be improved in the future from the aspects of strengthening project supervision，strengthening personnel training and increasing input from all parties.
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