2008年是奥运举办之年,为了确保运动员、教练员、旅游观光者购买到安全有效的医疗器械,北京市药监密云分局加大了直接面向消费者的医疗器械经营企业检查力度。根据我们近半年来的监管实践,结合目前存在的问题,对如何加强对该类企业的监督管理做一初步探讨。 2008 is the year when the Olympics are held. In order to ensure that athletes, coaches and tourists have purchased safe and effective medical devices, Miyun Branch of Beijing Municipality has stepped up its inspection of directly-facing consumer-oriented medical device operators. According to our past six months of regulatory practice, combined with the existing problems, how to strengthen the supervision and management of such enterprises to do a preliminary discussion.