Regulation on the Supervision and Administration of Medical Devices (2017 Revision),北大法宝V6

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

[CLI Code] CLI.2.295093(EN) Statement

Document Number：Order No. 680 of the State Council
Area of Law： Import and Export of Medical Devices, Drugs, and Medicine Materials Epidemic Prevention and Control
Level of Authority： Administrative Regulations
Date Issued：05-04-2017
Effective Date：05-04-2017
Issuing Authority： State Council
Status： Revised
Revised by：Regulation on the Supervision and Administration of Medical Devices (2021 Revision) (Issued on 02-09-2021 Effective on 06-01-2021)
Pkulaw Note：Decision of the State Council to Suspend the Implementation of the Relevant Provisions of the Regulation on the Supervision and Administration of Medical Devices in Hainan Bo'ao Lecheng International Medical Tourism Pilot Zone (Issued on 04-02-2018 Effective on 04-02-2018);Decision of the State Council to Temporarily Adjust the Implementation of the Relevant Provisions of Administrative Regulations in Pudong New Area of Shanghai Municipality (Issued on 08-04-2018 Effective on 08-04-2018)

2017-2021 Comparison Version 2014-2017 Annotation Version 2000-2014 Comparison Version

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Revision History

(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）

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。