2017年,在国家一系列改革政策指引下,各级食品药品监督管理部门加大了科学监管力度,监管法规政策不断完善,公众用械安全有效得到了较好的保障。医疗器械行业面临政策生态环境变化,行业监管、审评审批、医保制度、集中采购、两票制、分级诊疗等政策相继推出。绝大多数医疗器械生产经营企业注重内部管理,加大创新研发投入,创新医疗器械产品增多,整个行业在调整中健康前行,发展前景十分广阔。本报告对2018年医疗器械行业的发展趋势进行了分析,对未来进行了展望。医疗器械行业依然面临着一些突出的问题,需要深入研究,采取有力措施,逐步加以解决。
<<In 2017,the safety of using of medical devices has been effectively guaranteed with a series of national reform policies and the scientific supervision of CFDA. The medical equipment industry is facing the change of the policy ecological environment,the industry supervision policies,review and approval,medical insurance system,centralized purchasing,two ticket system and grading diagnosis and treatment and so on. The most medical equipment enterprises pay attention to internal management,increasing the investment of innovative research and development and innovating medical equipment products. The whole industry is on the way of growing healthily,and the development prospect is very broad. This report analyses the development trend of the medical equipment industry in 2018. The medical device industry is still facing some outstanding problems. It needs in-depth study and takes effective measures to solve it step by step.
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