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2014年2月12日,《醫療器械監督管理條例(修訂草案)》經國務院常務會議審議通過。修訂草案對現行《條例》做了全面修改,共8章80條,有利於完善食品藥品監管法律體系,保證醫療器械使用安全、有效,維護公民健康和生命安全。現行《醫療器械監督管理條例》於2000年頒佈施行,十多年來,隨著我國醫療器械產業發展變化,其不適應行業發展新變化的情況突出,業界要求修訂的呼聲強烈。2006年,原國家食品藥品監管局啟動修訂工作,先後組織開展數十項課題研究,廣泛聽取各方意見,於2008年3月向國務院法制辦上報
February 12, 2014, “Medical Device Supervision Regulations (Revised Draft)” by the State Council executive meeting examined and adopted. The draft revision of the “Ordinance” made a comprehensive revision, a total of 8 80, is conducive to improving the food and drug regulatory legal system to ensure the safe and effective use of medical devices, safeguarding citizens’ health and life safety. The current “Regulations on the Supervision and Administration of Medical Devices” was promulgated in 2000. Over the past decade, with the development of the medical device industry in our country, the situation of not adapting to the new changes in the industry has become prominent. The industry demands strong revision. In 2006, the former State Food and Drug Administration initiated the revision work and successively organized dozens of research projects to listen to the opinions of all parties and report to the Legal Affairs Office of the State Council in March 2008