中华人民共和国国务院令

Decree of the State Council of the People’s Republic of China

第680号

No. 680

现公布《国务院关于修改〈医疗器械监督管理条例〉的决定》，自公布之日起施行

The Decision of the State Council on Amending the Regulations on Supervision and Administration of Medical Devices is hereby issued, and shall come into force on the date of issuance.

总理 李克强

Premier: Li Keqiang

2017年5月4日

May 4, 2017

国务院关于修改《医疗器械

监督管理条例》的决定

Decision of the State Council on Amending the Regulations on Supervision and Administration of Medical Devices

国务院决定对《医疗器械监督管理条例》作如下修改：

The State Council decides to amend the Regulations on Supervision and Administration of Medical Devices as follows:

一、将第十八条修改为：“开展医疗器械临床试验，应当按照医疗器械临床试验质量管理规范的要求，在具备相应条件的临床试验机构进行，并向临床试验提出者所在地省、自治区、直辖市人民政府食品药品监督管理部门备案。接受临床试验备案的食品药品监督管理部门应当将备案情况通报临床试验机构所在地的同级食品药品监督管理部门和卫生计生主管部门。

I. Article 18 is amended to read: “Clinical trials for a medical devices shall be executed by a qualified clinical trial institution in compliance with the Specifications for Quality Control of Clinical Trials for Medical Devices and shall be reported for filing to the Food and Drug Administration Department of the people's government of the province, autonomous region or municipality directly under the Central Government where the clinical trial presenter is located. The Food and Drug Administration Department accepting the filing of the clinical trial shall notify the filing situation to the Food and Drug Administration Department and the Health and Family Planning Administration Department of the same level where the clinical trial institution is located.

“医疗器械临床试验机构实行备案管理。医疗器械临床试验机构应当具备的条件及备案管理办法和临床试验质量管理规范，由国务院食品药品监督管理部门会同国务院卫生计生主管部门制定并公布。”

“Medical device clinical trial institutions shall be subject to filing administration. The conditions that a medical device clinical trial institution shall satisfy, the administrative filing measures and the specifications for quality control of clinical trials shall be developed and published by the Food and Drug Administration Department of the State Council in conjunction with the Health and Family Planning Administration Department of the State Council.”

二、将第三十四条第一款、第二款合并，作为第一款：“医疗器械使用单位应当有与在用医疗器械品种、数量相适应的贮存场所和条件。医疗器械使用单位应当加强对工作人员的技术培训，按照产品说明书、技术操作规范等要求使用医疗器械。”

II. In Article 34, Paragraph 1 and 2 are combined as Paragraph 1: “Medical device users shall have the storage place and conditions appropriate to the variety and quantity of the medical devices in use. Medical device users shall strengthen technical training for operating persons so as for them to use the medical device in accordance with the Instructions for Use, technical operation standard and other requirements.”

三、将第五十六条第一款、第二款合并，作为第一款：“食品药品监督管理部门应当加强对医疗器械生产经营企业和使用单位生产、经营、使用的医疗器械的抽查检验。抽查检验不得收取检验费和其他任何费用，所需费用纳入本级政府预算。省级以上人民政府食品药品监督管理部门应当根据抽查检验结论及时发布医疗器械质量公告。”

增加一款，作为第二款：“卫生计生主管部门应当对大型医用设备的使用状况进行监督和评估；发现违规使用以及与大型医用设备相关的过度检查、过度治疗等情形的，应当立即纠正，依法予以处理。”

III. In Article 56, Paragraph 1 and 2 are combined as Paragraph 1: “The Food and Drug Administration Department shall strengthen sampling inspection on all medical devices manufactured, operated, and used by medical device manufacturers, operators and users. No inspection fee or other expense shall be charged for such sampling inspection but all the expenses arising thereof shall be disbursed from the financial budget of the government at the same level. The food and drug administration departments of the people’s governments at or above the level of province shall timely publicize medical device quality announcements according to the conclusions of the sampling inspections.”

One paragraph is added as Paragraph 2: “The Health and Family Planning Administration Department shall supervise and evaluate the use of large medical devices. In case of illegal use of a large medical device or large medical device related excessive testing or therapy, immediate rectification and punishment shall be carried out according to law.”

四、第六十三条增加一款，作为第三款：“未经许可擅自配置使用大型医用设备的，由县级以上人民政府卫生计生主管部门责令停止使用，给予警告，没收违法所得；违法所得不足1万元的，并处1万元以上5万元以下罚款；违法所得1万元以上的，并处违法所得5倍以上10倍以下罚款；情节严重的，5年内不受理相关责任人及单位提出的大型医用设备配置许可申请。”

IV. In Article 63, one paragraph is added to as Paragraph 3: “In case of deployment and use of large medical devices without authorization, the Health and Family Planning Administration Department of the people’s government at or above the level of county shall order the discontinuation of use, issue a warning, confiscate the illegal income, and impose a fine. If the illegal income is less than RMB 10,000, the fine shall be more than RMB 10,000 but less than RMB 50,0000; if the illegal income is more than RMB10,000, the fine shall be more than 5 times but less than 10 times of the illegal income. In case of gross violation, any Large Medical Device Deployment Permit application from the person and enterprise concerned shall be rejected within the next 5 years.”

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十、第七十六条增加规定：“大型医用设备，是指使用技术复杂、资金投入量大、运行成本高、对医疗费用影响大且纳入目录管理的大型医疗器械。”

X. In Article 76, one paragraph is added to read: “Large Medical Device refers to large-sized medical devices involving complex technology, high capital investment, high operating costs, and high impact on medical expenses which are included in the catalogue of large medical devices for administration.”

本决定自公布之日起施行。

This decision shall come into force as of the date of promulgation

《医疗器械监督管理条例》根据本决定作相应修改，重新公布。

The Regulations on Supervision and Administration of Medical Devices shall be revised and reissued in accordance.