| Order of the State Council | | 国务院令 |
| (No. 680) | | （第680号） |
| TheDecision of the State Council on Amending the Regulation on the Supervision and Administration of Medical Devices is hereby issued, and shall come into force on the date of issuance. | | 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。 |
| Premier: Li Keqiang | | 总理 李克强 |
| May 4, 2017 | | 2017年5月4日 |
| Decision of the State Council on Amending the Regulation on the Supervision and Administration of Medical Devices | | 国务院关于修改《医疗器械监督管理条例》的决定 |
| The State Council decides to amend the Regulation on the Supervision and Administration of Medical Devices as follows: | | 国务院决定对《医疗器械监督管理条例》作如下修改： |
| I. Article 18 is amended to read: “The clinical trials of medical devices shall be conducted in the clinical trial institutions that meet the corresponding conditions in accordance with the requirements of the quality management norms for the clinical trials of medical devices, and be reported for recordation to the food and drug administration departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government where the clinical trial presenters are located. The food and drug administration departments accepting the clinical trial recordation shall notify the recordation information to the food and drug administration departments and administrative departments of health and family planning at the same levels at the places where the clinical trial institutions are located. | | 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。 |
| “Medical device clinical trial institutions shall be subject to recordation administration. The conditions that medical device clinical trial institutions shall satisfy and recordation administration measures and the clinical trial quality management norms shall be developed and published by the food and drug administration department of the State Council in conjunction with the administrative department of health and family planning of the State Council.” | | “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。” |
| II. In Article 34, paragraphs 1 and 2 are combinedas paragraph 1: “Medical device use entities shall have the storage places and conditions commensurate with the varieties and quantities of the medical devices in use. Medical device use entities shall strengthen the technical training of staff members, so as to use medical devices in accordance with the product instructions, technical operation rules and other requirements.” | | 二、 |
One paragraph is added as paragraph 2: “To purchase large-scale medical equipment, medical device use entities shall comply with theplans on the purchase of large-scale medical equipmentdeveloped by the administrative department of health and family planning of the State Council, ensure that the large-scale medical equipment is commemorate with their functional orientation and clinical service needs, that they have corresponding technical conditions, supporting facilities and professional technicians with corresponding qualifications and abilities, and obtain the large-scale medical equipment purchase permits upon approval by the administrative departments of health and family planning of the people's governments at or above the provincial level.”
．．．．．． | | 增加一款，作为第二款：“医疗器械使用单位配置大型医用设备，应当符合国务院卫生计生主管部门制定的大型医用设备配置规划，与其功能定位、临床服务需求相适应，具有相应的技术条件、配套设施和具备相应资质、能力的专业技术人员，并经省级以上人民政府卫生计生主管部门批准，取得大型医用设备配置许可证。”
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