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2017年1月19日,国家食品药品监督管理总局发布YY/T0287-2017/ISO13485:2016《医疗器械质量管理体系用于法规的要求》标准,将于2017年5月1日起实施。YY/T0287-2017《医疗器械质量管理体系用于法规的要求》(以下简称新版标准)等同采用了ISO13485:2016标准。随着当前的社会的变革、经济的发展,新一轮科技产业革命的兴起对医疗器械产业产生了重大和深远的影响,医疗器械的生产方式、营销模式正在改变,特别是全球市场一体化进程的提速,导致医疗器械产业链延伸和日趋复杂,包括中国在内
January 19, 2017, the State Food and Drug Administration issued YY / T0287-2017 / ISO13485: 2016 “medical device quality management system for regulatory requirements” standard, will be May 1, 2017 come into operation. YY / T0287-2017 “medical device quality management system for regulatory requirements” (hereinafter referred to as the new standard) equivalent to the use of the ISO13485: 2016 standard. With the current social transformation and economic development, the rise of a new round of technological revolution has had a profound and far-reaching impact on the medical device industry. The mode of production and marketing of medical devices are changing, especially in the process of global market integration Speed up, resulting in the extension and increasingly complex medical device industry chain, including China