《医疗器械监督管理条例》颁布实施已一周年 ,这是建国以来我国颁布的关于医疗器械的第一部法规 ,医疗器械的监督管理从此走上了法制化、规范化的轨道。《条例》明确规定对医疗器械实施分类管理 ,并出台了《医疗器械分类规则》 ,规定“应依据医疗器械的结构特征、医疗器械使用 The first anniversary of promulgation and implementation of the Regulation on the Supervision and Administration of Medical Devices is the first regulation on medical devices promulgated by our country since the founding of the People’s Republic of China. The supervision and administration of medical devices has since embarked on a legal and standardized track. “Ordinance” clearly provides for the implementation of classification management of medical devices, and promulgated the “classification rules for medical devices,” provides that "should be based on the structural characteristics of medical devices, medical devices to use