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2019年，我国医疗器械行业在国家一系列法规政策指导下健康发展。医疗器械行业生产企业数量、经营企业数量均有所增加，医疗器械进出口贸易连续11年保持增长势头，研发总投入已经占同年营业收入的7。41%，正在逐步接近跨国医疗器械公司的研发投入水平。2019年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监管，不断强化法规标准基础建设，有力地推动了我国医疗器械行业的健康快速发展。2019年，虽然面临诸多不确定因素，但我国良好的政治环境与经济环境、扶贫政策和医疗保障政策调整、多项鼓励科技创新政策的实施都为医疗器械行业的健康发展提供了有利条件。2020年初，新冠肺炎疫情突如其来。党中央国务院果断决策，迅速组织动员全国人民开展了抗击新冠肺炎的伟大斗争，经过几个月的时间即取得了重大战略成果。目前，我国新冠肺炎防控已经进入常态化防控阶段，社会经济生活已恢复常态。综合分析，我们认为：未来一年我国医疗器械行业仍将处于“黄金发展期”。
<<In 2019，China’s medical equipment industry developed healthily under the guidance of a series of national regulations and policies. The number of medical device enterprises and the number of operating enterprises have increased. The medical device import and export trade has maintained its growth momentum for 11 years. The total investment in research and development has accounted for 7.41% of the business income of the same year. It is gradually approaching the level of R & D investment of multinational medical device companies. In 2019，the national pharmaceutical supervision and administration departments have pushed forward the reform of medical device examination and approval system，continuously strengthened the construction of medical device’s whole life cycle，and the legal standard，and the foundation，which has strongly promoted the healthy and rapid development of medical device industry.
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