2018年,我国医疗器械行业监督管理工作面临机构改革、监管任务繁重的双重压力。国家药品监督管理局坚持一手抓改革、一手抓监管,特别是在医疗器械监管政策创新方面发力,引领我国医疗器械行业健康发展。本报告从我国医疗器械行业发展概况、医疗器械行业监管情况、医疗器械监管法规体系建设进展、医疗器械监管体制改革进展、医疗器械行业政策环境的变化、医疗器械行业发展趋势等方面进行了概述,为我国医疗器械行业监管和发展提供参考和借鉴。
<<In 2018,China’s supervision of medical device industry is facing double pressures of institutional reform and heavy supervision tasks. The National Medical Products Administration insists on reform and supervision,especially in innovation for policy and regulatory system of medical device supervision,which leads to the healthy development of China’s medical device industry. The report summarizes some progress in the medical device industry,such as general development situation,the supervision situation,the construction of medical device regulation system,the supervision system of medical device,the change of policy environment,and the development trend. It provides reference for the supervision and development of the medical device industry.
<<