Circular on the Launching of a Pilot Project for the Establishment of Wholly Foreign-owned Hospitals
关于开展设立外资独资医院试点工作的通知
Wholly foreign-owned hospitals permitted in seven municipalities and provinces.
(Issued by the National Health and Family Planning Commission and the Ministry of Commerce on July 25 2014.)
(国家卫生计生委及商务部于二零一四年七月二十五日发布。)
Guo Wei Yi Han [2014] No.244
国卫医函〔2014〕244号
Health and family planning commissions and competent commerce departments of Beijing Municipality, Tianjin Municipality, Shanghai Municipality, Jiangsu Province, Fujian Province, Guangdong Province and Hainan Province:
北京市、天津市、上海市、江苏省、福建省、广东省、海南省卫生计生委、商务主管部门：
In keeping with the spirit of the Central Committee of the Communist Party of China, Decision on Several Major Issues Concerning Comprehensively Intensifying Reform and the State Council, Several Opinions on Promoting the Development of the Health Service Industry (Guo Fa [2013] No.40), we have decided to launch a pilot project for the establishment of wholly foreign-owned hospitals in Beijing and six other provinces and municipalities in order to promote the development of the health service industry and better satisfy the demand of the public for medical services. We hereby notify you of relevant matters as follows:
为推进健康服务业发展，更好地满足人民群众医疗服务需求，根据《中共中央关于全面深化改革若干重大问题的决定》和《国务院关于促进健康服务业发展的若干意见》（国发〔2013〕40号）精神，决定在北京等7省（市）开展设立外资独资医院试点工作。现就有关事项通知如下：
I. Scope of the pilot project
一、试点范围
From the date of issuance hereof, overseas investors shall be permitted to establish wholly foreign-owned hospitals in Beijing Municipality, Tianjin Municipality, Shanghai Municipality, Jiangsu Province, Fujian Province, Guangdong Province and Hainan Province through new establishment or acquisition. Except for investors from Hong Kong, Macao and Taiwan, other overseas investors may not establish traditional Chinese medicine hospitals in the aforementioned provinces and municipalities.
从本通知印发之日起，允许境外投资者通过新设或并购的方式在北京市、天津市、上海市、江苏省、福建省、广东省、海南省设立外资独资医院。除香港、澳门和台湾投资者外，其它境外投资者不得在上述省（市）设置中医类医院。
II. Establishment requirements
二、设置要求
(1) An overseas investor that applies to establish a wholly foreign-owned hospital shall be a legal person with the capacity to independently bear civil liability, have experience in directly or indirectly engaging in medical and health investment and management and satisfy one of the following conditions:
（一）申请设立外资独资医院的境外投资者应是能够独立承担民事责任的法人，具有直接或间接从事医疗卫生投资与管理的经验，并符合下列要求之一：
1. being capable of providing an internationally advanced hospital management philosophy, management model and service model;
1.能够提供国际先进的医院管理理念、管理模式和服务模式；
2. being capable of providing medical technology and equipment of international sophistication; or
2.能够提供具有国际领先水平的医学技术和设备；
3. being able to supplement or improve the local insufficiency in medical service capacity, medical technology, funds and medical facilities.
3.可以补充或改善当地在医疗服务能力、医疗技术、资金和医疗设施方面的不足。
(2) A proposed wholly foreign-owned hospital shall satisfy the basic standards for medical institutions formulated by the state. In the absence of a state standard, the Ministry of Health, Circular on Provisions Relevant to Administration of the Examination and Approval of the Establishment of Specialised Hospitals (Wei Yi Zheng Fa [2011] No.87) shall apply.
（二）拟申请设立的外资独资医院应当符合国家制定的医疗机构基本标准。没有国家标准的，执行《卫生部关于专科医院设置审批管理有关规定的通知》（卫医政发〔2011〕87号）。
(3) The authority for examining and approving the establishment of wholly foreign-owned hospitals is delegated to the provincial level. An overseas investor applying to establish a wholly foreign-owned hospital shall submit its application to the administrative department for health and family planning (here and hereafter including the administrative department for traditional Chinese medicine) at the level of city (divided into districts) of the place where it proposes to establish the hospital. The administrative department for health and family planning at the level of city (divided into districts) shall give its preliminary opinion and forward the application to the provincial-level administrative department for health and family planning for examination and approval. The provincial-level department in charge of commerce shall carry out the examination and approval of the establishment of the wholly foreign-owned hospital on the strength of the administrative permission from the provincial-level administrative department for health and family planning and pursuant to foreign investment laws and regulations.
（三）外资独资医院的设置审批权限下放到省级。申请设置外资独资医院的境外投资者应向拟设置外资独资医院所在地设区的市级卫生计生行政部门（含中医药管理部门，下同）提出申请，设区的市级卫生计生行政部门提出初审意见，报省级卫生计生行政部门审批。省级商务主管部门凭省级卫生计生行政部门的行政许可，依据外商投资法律法规进行外资独资医院设立的审批工作。
(4) The establishment of and changes to wholly foreign-owned hospitals shall be carried out in accordance with the procedures and requirements set forth in the Regulations for the Administration of Medical Institutions, the Implementing Rules for the Regulations for the Administration of Medical Institutions and the Measures for the Administration of Foreign Investment in the Commercial Sector.
（四）外资独资医院的设立和变更应按照《医疗机构管理条例》、《医疗机构管理条例实施细则》和《外商投资商业领域管理办法》等规定的程序和要求办理。
(5) The establishment of a wholly foreign-owned hospital shall additionally satisfy the other conditions and requirements specified by the provincial-level administrative department for health and family planning and department in charge of commerce of the pilot province (municipality).
（五）设立外资独资医院还应符合试点省（市）省级卫生计生行政部门及商务主管部门规定的其他条件和要求。
III. Arrangements for implementation
三、组织实施
(1) The provincial-level administrative department for health and family planning and department in charge of commerce shall themselves formulate the implementing plan for the pilot project for the establishment of wholly foreign-owned hospitals for their province (municipality) based on the principles of gradual relaxation and controllability of risks, and be responsible, within their respective purviews, for the examination and approval and day-to-day regulation of wholly foreign-owned hospitals in their administrative regions. Before implementation, copies of such implementing plans shall be forwarded to the National Health and Family Planning Commission and the Ministry of Commerce.
（一）省级卫生计生行政部门和商务主管部门要按照逐步开放、风险可控的原则，制订本省（市）设立外资独资医院的试点实施方案，并在各自职责范围内负责本行政区域内外资独资医院的审批和日常监督管理工作。试点实施方案在执行前需抄报国家卫生计生委和商务部。
(2) The establishment of a wholly foreign-owned hospital must comply with relevant state laws, regulations and rules, including implementation of clinical practice conventions and technical standards, and relevant provisions such as the rules and regulations for medical technology entry, and management of medical quality shall be enhanced and medical safety shall be ensured.
（二）设立外资独资医院必须遵守国家有关法律、法规和规章，包括执行临床诊疗常规和技术规范，执行医疗技术准入的规章制度等相关规定，加强医疗质量管理，保障医疗安全。
(3) The administrative departments for health and family planning of the pilot provinces and municipalities shall regulate wholly foreign-owned hospitals in accordance with laws and regulations and duly carry out the work of submitting data in accordance with relevant requirements for the administration of medical institution practice registration information.
（三）试点省（市）卫生计生行政部门要依法依规对外资独资医院实施监督管理，并按照医疗机构执业登记信息管理的有关要求，做好数据的报送工作。
If an issue is encountered in the course of the pilot project, you are asked to contact the National Health and Family Commission and the Ministry of Commerce in a timely manner.
试点中遇到的问题，请及时联系国家卫生计生委和商务部。
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