| Regulation on the Administration of Medical Institutions | | 医疗机构管理条例 |
| (Promulgated by the Order No. 149 of the State Council of the People's Republic of China on February 26, 1994; and revised in accordance with the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016) | | （1994年2月26日中华人民共和国国务院令第149号发布 根据2016年2月6日《国务院关于修改部分行政法规的决定》修订） |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 This Regulation is developed for purposes of strengthening the administration of medical institutions, promoting the development of the medical and health cause, and protecting the health of citizens. | | 第一条 为了加强对医疗机构的管理，促进医疗卫生事业的发展，保障公民健康，制定本条例。 |
| Article 2 This Regulation shall apply to hospitals, health centers, nursing homes, out-patient departments, clinics, health clinics (stations), first aid stations and other medical institutions engaging in the diagnosis and treatment of diseases. | | 第二条 本条例适用于从事疾病诊断、治疗活动的医院、卫生院、疗养院、门诊部、诊所、卫生所（室）以及急救站等医疗机构。 |
| Article 3 Medical institutions aim at retrieving the dying or rescuing the wounded, preventing and curing disease, and serving for the health of citizens. | | 第三条 医疗机构以救死扶伤，防病治病，为公民的健康服务为宗旨。 |
| Article 4 The state shall support the development of medical institutions and encourage the establishment of medical institutions in various forms. | | 第四条 国家扶持医疗机构的发展，鼓励多种形式兴办医疗机构。 |
| Article 5 The health administrative department of the State Council shall be responsible for the supervision and administration of the medical institutions across the country. | | 第五条 国务院卫生行政部门负责全国医疗机构的监督管理工作。 |
| The health administrative departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of the medical institutions within their respective administrative regions. | | 县级以上地方人民政府卫生行政部门负责本行政区域内医疗机构的监督管理工作。 |
| The competent health department of the Chinese People's Liberation Army shall, under this Regulation and the relevant provisions of the state, implement supervision and administration of the medical institutions of the Army. | | 中国人民解放军卫生主管部门依照本条例和国家有关规定，对军队的医疗机构实施监督管理。 |
| Chapter II Approval for Planning Layout and Formation | | 第二章 规划布局和设置审批 |
| Article 6 The health administrative departments of the local people's governments at or above the county level shall, according to the population, medical resources, medical needs and the distribution of the existing medical institutions in their respective administrative regions, develop plans for the formation of medical institutions within their respective administrative regions. | | 第六条 县级以上地方人民政府卫生行政部门应当根据本行政区域内的人口、医疗资源、医疗需求和现有医疗机构的分布状况，制定本行政区域医疗机构设置规划。 |
| Organs, enterprises and public institutions may, according to the needs, form medical institutions and incorporate them into the plans for the formation of local medical institutions. | | 机关、企业和事业单位可以根据需要设置医疗机构，并纳入当地医疗机构的设置规划。 |
| Article 7 The local people's governments at or above the county level shall incorporate the plans for the formation of medical institutions into the local regional health development plans and overall plans for urban and rural construction and development. | | 第七条 县级以上地方人民政府应当把医疗机构设置规划纳入当地的区域卫生发展规划和城乡建设发展总体规划。 |
| Article 8 The formation of medical institutions shall comply with the plans for the formation of medical institutions and the basic standards for medical institutions. | | 第八条 设置医疗机构应当符合医疗机构设置规划和医疗机构基本标准。 |
| The basic standards for medical institutions shall be developed by the health administrative department of the State Council. | | 医疗机构基本标准由国务院卫生行政部门制定。 |
| Article 9 To form a medical institution, an entity or individual shall be subject to the examination and approval of the health administrative department of the local people's government at or above the county level and obtain the written approval for the formation of medical institutions. | | 第九条 单位或者个人设置医疗机构，必须经县级以上地方人民政府卫生行政部门审查批准，并取得设置医疗机构批准书。 |
| Article 10 To apply for forming a medical institution, an applicant shall submit the following documents: | | 第十条 申请设置医疗机构，应当提交下列文件： |
| (1) A written application for the formation. | | （一）设置申请书； |
| (2) A feasibility study report for the formation. | | （二）设置可行性研究报告； |
| (3) A site selection report and the drawings of architectural design. | | （三）选址报告和建筑设计平面图。 |
| Article 11 To form a medical institution, an entity or individual shall file an application for formation under the following provisions: | | 第十一条 单位或者个人设置医疗机构，应当按照以下规定提出设置申请： |
| (1) For a medical institution that has no sickbeds or has less than 100 sickbeds, an application shall be filed with the health administrative department of the people's government of the county where it is located. | | （一）不设床位或者床位不满100张的医疗机构，向所在地的县级人民政府卫生行政部门申请； |
| (2) For a medical institution or specialized hospital that has more than 100 sickbeds, an application shall be filed under the provisions of the health administrative department of the people's government at the provincial level. | | （二）床位在100张以上的医疗机构和专科医院按照省级人民政府卫生行政部门的规定申请。 |
| Article 12 The health administrative department of the local people's government at or above the county level shall, within 30 days of the date of accepting an application for formation, issue a written reply of approval or disapproval; and issue a written approval for the formation of an institution, where approval is granted. | | 第十二条 县级以上地方人民政府卫生行政部门应当自受理设置申请之日起30日内，作出批准或者不批准的书面答复；批准设置的，发给设置医疗机构批准书。 |
| Article 13 The formation of medical institutions under the unified plan of the state shall be decided by the health administrative department of the State Council. | | 第十三条 国家统一规划的医疗机构的设置，由国务院卫生行政部门决定。 |
| Article 14 Organs, enterprises and public institutions that form out-patient departments, clinics and health clinics (stations) serving their employees according to the basic standards of the state for medical institutions shall submit the relevant materials to the health administrative departments of the people's governments of the county where they are located for recordation. | | 第十四条 机关、企业和事业单位按照国家医疗机构基本标准设置为内部职工服务的门诊部、诊所、卫生所（室），报所在地的县级人民政府卫生行政部门备案。 |
| Chapter III Registration | | 第三章 登 记 |
| Article 15 A medical institution providing relevant services shall conduct registration and obtain the Practicing License for a Medical Institution. | | 第十五条 医疗机构执业，必须进行登记，领取《医疗机构执业许可证》。 |
| Article 16 To apply for practicing registration, a medical institution shall meet the following conditions: | | 第十六条 申请医疗机构执业登记，应当具备下列条件： |
| (1) It has a written approval for the formation of a medical institution. | | （一）有设置医疗机构批准书； |
| (2) It complies with the basic standards for medical institutions. | | （二）符合医疗机构的基本标准； |
| (3) It has an appropriate name, organizing institution and place. | | （三）有适合的名称、组织机构和场所； |
| (4) It has funds, facilities, equipment and professional health technical personnel that are compatible with the business carried out. | | （四）有与其开展的业务相适应的经费、设施、设备和专业卫生技术人员； |
| (5) It has corresponding rules and regulations. | | （五）有相应的规章制度； |
| (6) It is able to independently assume civil responsibilities. | | （六）能够独立承担民事责任。 |
| Article 17 The practicing registration of medical institutions shall be handled by the health administrative departments of the people's governments approving their formation. | | 第十七条 医疗机构的执业登记，由批准其设置的人民政府卫生行政部门办理。 |
| The practicing registration of medical institutions formed under the provisions of Article 13 of this Regulation shall be handled by the health administrative departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government where they are located. | | 按照本条例第十三条规定设置的医疗机构的执业登记，由所在地的省、自治区、直辖市人民政府卫生行政部门办理。 |
| The practicing registration of the out-patient departments, clinics and health clinics (stations) formed by organs, enterprises and public institutions for serving their employees shall be handled by the health administrative departments of the people's governments of the county where they are located. | | 机关、企业和事业单位设置的为内部职工服务的门诊部、诊所、卫生所（室）的执业登记，由所在地的县级人民政府卫生行政部门办理。 |
| Article 18 The main items of the practicing registration of a medical institution include: | | 第十八条 医疗机构执业登记的主要事项： |
(1) the name, address and primary person in charge;
．．．．．． | | （一）名称、地址、主要负责人；
．．．．．． |
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