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Regulation on the Supervision and Administration of Medical Devices (2017 Revision) Revised

医疗器械监督管理条例(2017修订)

  • Regulation on the Supervision and Administration of Medical Devices
  • 医疗器械监督管理条例

  • (Promulgated by the Order No. 276 of the State Council of the People's Republic of China on January 4, 2000; revised and adopted at the 39th executive meeting of the State Council on February 12, 2014; and revised in accordance with the Decision of the State Council on Amending the Regulation on the Supervision and Administration of Medical Devices on May 4, 2017)
  • (2000年1月4日中华人民共和国国务院令第276号公布 2014年2月12日国务院第39次常务会议修订通过 根据2017年5月4日《国务院关于修改〈医疗器械监督管理条例〉的决定》修订)

  • Chapter I General Provisions
  • 第一章 总  则

  • Article 1 This Regulation is formulated for the purposes of ensuring the safety and effectiveness of medical devices and guaranteeing human health and life safety.
  •   第一条 为了保证医疗器械的安全、有效,保障人体健康和生命安全,制定本条例。
  • Article 2 Whoever engages in the research and development, production, operation, use as well as supervision and administration of medical devices within the territory of the People's Republic of China shall abide by this Regulation.
  •   第二条 在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理,应当遵守本条例。
  • Article 3 The food and drug supervision and administration department of the State Council shall be responsible for the supervision and administration of the medical devices nationwide. The relevant departments of the State Council shall be responsible for the supervision and administration with respect to medical devices within their respective functions.
  •   第三条 国务院食品药品监督管理部门负责全国医疗器械监督管理工作。国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。
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