一、立法依据　　《医疗器械监督管理条例》 (下称《条例》)于 2 0 0 0年4月 1日开始实施 ,医疗器械监督管理工作步入法制化轨道。医疗器械标准是医疗器械研制、生产、经营、使用和监督管理共同遵守的技术法规。医疗器械标准工作是整个监督管理工作的技术基础。从《条例》发布 I. Legislative Basis The Regulations on the Supervision and Administration of Medical Devices (the “Regulations”) came into effect on April 1, 2000, and the supervision and administration of medical devices have been put on the legal track. Medical device standard medical device development, production, operation, use and supervision and management of common technical regulations. Medical equipment standard work is the technical basis of the entire supervision and management. From the “Regulations” released