加快《医疗器械监督管理条例(修正案)》发布的重大意义

Great Significance of Accelerating Publishing Medical Equipment Supervision and Management Regulations(Amendment)

自2005年启动《医疗器械监督管理条例(修正案)》的修改工作已经有7年之久,日前国务院法制办发布了(第三次征求意见稿)。学习了这篇《医疗器械监督管理条例(修正稿)》,感到切合医疗器械监管实际,面貌为之一新,引入许多新的监管理念,具有创新的行政许可和监管的设计。当然,新的监管制度必然会引发许多新的问题,探索新的制度设计。为此,在初步解读的基础上,抛砖引玉,发表一点心得。

Since medical equipment supervision and management regulations （Amendment） started modification in 2005, 7 years have passed. A few days ago, the Legal Affairs Office of the State Council issued Amendment Third Draft. After studied the draft, we feel it suits the medical device regulatory practice, has a new look, and introduces many new regulatory concepts, with innovative administrative license and regulatory design, of course, the new regulatory regime will inevitably initiate many new problems, explore some new system design. Therefore, based on preliminary interpretation, we publish some experiences, throw away a brick in oredr toget a gem.