近年来,医疗器械的违法违规行为有明显上升趋势。从前的案件来源主要依靠群众举报和抽检,近年来,北京市药品监督管理局房山分局立案查处的医疗器械案件中,通过日常监管途径获得案件来源的情形越来越多。在日常的监督执法中笔者体会到,《医疗器械监督管理条例》的出台,在规范基 In recent years, the illegal acts of medical devices have a clear upward trend. In the past, the source of the previous cases relied mainly on reporting and sampling by the masses. In recent years, cases of medical devices that have been investigated and prosecuted by Fangshan Branch of the Beijing Municipal Drug Administration have received more and more cases through routine supervision. In the daily supervision and law enforcement I realized that the “Regulations on the Supervision and Administration of Medical Devices,” the promulgation of norms