Wholly Foreign-Owned Hospitals in China: The Nine-City Pilot, the Medical Institution Licence and What Stays Closed
- The permission to set up a Wholly Foreign-Owned Hospital rests on a notice of 7 September 2024 issued by the Ministry of Commerce, the National Health Commission and the National Medical Products Administration, not on any rule issued in 2026.
允许设立外商独资医院的依据，是商务部、国家卫生健康委、国家药监局 2024 年 9 月 7 日印发的试点通知，而不是 2026 年出台的任何新规。
- The Nine-City Pilot covers Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and the whole of Hainan Island.
九地试点包括北京、天津、上海、南京、苏州、福州、广州、深圳和海南全岛。
- Traditional Chinese Medicine is excluded from the pilot and public hospitals may not be acquired; those are the two hard boundaries of the permission.
中医类不在试点范围内，也不含并购公立医院——这是这项许可的两条硬边界。
- The operational plan for the wholly foreign-owned hospital pilot took effect in April 2025 and fixes the pilot areas, access conditions and scope of business a project must satisfy.
独资医院领域扩大开放试点工作方案于 2025 年 4 月施行，确定了试点地区、准入条件和经营范围等具体要求。
- A wholly foreign-owned hospital is a medical institution rather than an ordinary foreign-invested company: it needs pre-establishment approval and then a Medical Institution Licence before it can treat a patient.
外商独资医院是医疗机构，不是普通外商投资企业：须先取得设置批准，再取得《医疗机构执业许可证》，才能接诊。
- On 22 October 2026 the Ministry of Commerce said it would deepen the opening pilot in wholly foreign-owned hospitals; that is a statement of direction, it adds no city to the list, and any expansion depends on a formal document.
2026 年 10 月 22 日商务部表示将深化独资医院等领域开放试点；这是方向性表述，并未新增试点地区，是否扩围取决于正式文件。
- Foreign doctors need their own Practising Registration and imported devices and medicines need registration or filing with the national drug regulator; a hospital licence covers neither.
外籍医师须另行办理执业注册，进口医疗器械与药品须取得国家药监部门注册或备案；医院执业许可不覆盖这两项。
Wholly Foreign-Owned Hospitals in China: The Nine-City Pilot, the Medical Institution Licence and What Stays Closed | 外商独资医院扩大试点：九地名单、执业许可与尚未开放的部分
Overview
A foreign hospital group looking at China meets two documents, and the order in which it reads them decides whether the project is viable. The first is the negative list for foreign investment, which still treats medical institutions as a restricted sector. The second is the notice of 7 September 2024 issued by the Ministry of Commerce, the National Health Commission and the National Medical Products Administration, which permits wholly foreign-owned hospitals in nine places: Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and the whole of Hainan Island.
In April 2025 the operational plan for the wholly foreign-owned hospital pilot took effect, setting out pilot areas, access conditions and scope of business in working detail. That plan, rather than the 2024 notice, is what a project team should read line by line.
Nothing changed in October 2026. At a State Council Information Office briefing on 22 October 2026, Wu Di of the Ministry of Commerce’s foreign investment administration said the ministry would deepen the opening pilots in cloud computing, biotechnology and wholly foreign-owned hospitals to release service-sector investment potential. That is a statement of direction. It adds no city to the list, and any expansion will arrive through a formal document. On ministry data, services took more than 70 per cent of China’s total actual use of foreign capital in 2025, which is why the sector keeps appearing in opening statements.
What the pilot permits
The permission is narrow. A wholly foreign-owned hospital may be established in one of the nine places to provide medical services other than those in the Traditional Chinese Medicine category, and it must satisfy the access conditions in the operational plan — conditions that run to the investor, the site, the bed scale, the departments and the staffing.
Two features of the design are easy to miss. The permission is place-specific: outside the nine places the negative list position is unchanged, so a group cannot take a licence granted in Shanghai and open a branch in Chengdu on the strength of it. And the permission is for establishment rather than unrestricted operation: the hospital still needs every ordinary licence a medical institution needs, plus the equipment and drug approvals described below.
The scope of business deserves early attention because it drives the investment case: a general hospital, a specialty hospital and a surgical centre meet different requirements on departments, beds and personnel, and provincial rules may add local conditions. Written confirmation of the intended scope, obtained before the feasibility study is signed off, is cheaper than discovering the mismatch at registration.
The two hard boundaries
Traditional Chinese Medicine is excluded. The exclusion is drawn at the level of the TCM category. A project that intends to offer acupuncture, tuina or herbal consultation alongside Western medicine should ask the provincial health commission how the exclusion applies to specific service lines, rather than assume that a TCM department inside a Western-medicine hospital sits outside the rule.
Public hospitals may not be acquired. The boundary is drawn at public hospitals specifically. Greenfield construction is the route the pilot contemplates. Other forms of participation in existing non-public facilities are governed by the operational plan and by provincial rules, and should be put to the authorities as a question rather than treated as settled.
The pilot is in any case an opening inside a restricted sector, not the removal of the restriction, and documents drafted for headquarters should say so.
From setting approval to a licence to practise
A wholly foreign-owned hospital is a medical institution, not an ordinary foreign-invested company, and the sequence reflects that.
The first step is pre-establishment approval — the setting approval required by the regulation on the administration of medical institutions. The application goes to the health authority at the level the operational plan specifies, in practice the provincial level, and carries the substance of the project: a feasibility study, site and floor plans, proposed beds, departments and staffing, funding evidence and the foreign investor’s own qualifications.
The second step is registration, which produces the Medical Institution Licence. The licence records the name, address, legal representative, principal person in charge, permitted diagnostic and treatment subjects and bed count. Treating patients before that licence issues is not a scheduling problem to be managed; it is practice without a licence.
The third step is corporate. The investor’s company is registered under the foreign investment law and files the foreign investment information report. The hospital licence and the company registration are separate instruments held by different authorities, and neither substitutes for the other.
Alongside these sit the permits that follow the building and the equipment: configuration approval for large medical equipment, radiation diagnosis and treatment permits, and environmental and fire acceptance. Together they set the critical path.
Three misconceptions
That wholly-owned means free pricing and free hiring. Non-public medical institutions set service prices under market adjustment rather than government guidance, but a hospital seeking medical insurance designation accepts the payment standards, price publicity and cost-control rules that come with it, and foreign doctors still need their own practising registration. Ownership displaces neither constraint.
That a public hospital can be bought. It cannot, under this pilot; a transaction structured as an acquisition of a public facility will not be approved on the strength of the 2024 notice.
That the model replicates nationally. The permission is confined to the nine places. A multi-city plan needs a multi-city legal analysis, and in most cities the answer today remains a joint venture.
People, devices, medicines and payment
Foreign doctors practising in China need registration of their own. Short-term practice requires a foreign physician short-term practice permit, valid for no more than one year; longer practice requires a Chinese physician qualification and registration. One regional variation is worth knowing: under the trade facilitation measures announced on 29 October 2026 for the Hainan Free Trade Port, the validity of the practising permit for foreign physicians in Hainan extends from one year to three. That is a Hainan-specific arrangement, and it matters when staffing costs for a Hainan site are modelled.
Imported medical devices need registration or filing with the National Medical Products Administration, and large equipment needs configuration approval before installation. Imported medicines need their own registration; the channels for clinically urgent, small-quantity imports are arrangements for specific areas and are not part of this pilot.
On payment, medical insurance designation is applied for locally and is not automatic. Most wholly foreign-owned hospitals in the pilot will run a mixed model: self-pay and commercial insurance direct billing for the core business, designation where local rules and the case allow it.
Research involving human genetic resources requires separate approval for collection, preservation and international cooperation.
Practical steps
- Choose the city first, then read that city’s implementing rules. The nine places do not implement identically.
- Open a pre-application channel with the provincial health commission and obtain written confirmation of the intended scope, bed scale and department list.
- Have the foreign investor’s qualification documents notarised and authenticated, with Chinese translations in the format the receiving authority expects.
- Sequence device registrations and physician registrations against the planned opening date; registration timelines, not construction, usually set the critical path.
- Confirm with the commerce department that the project falls inside the pilot, and keep that confirmation with the file supporting the foreign investment information report.
- Discuss insurance designation with the local medical insurance bureau early, because the answer shapes the revenue model rather than merely the billing process.
Outlook
The direction of travel is towards more service-sector opening, and hospitals are named in that direction. The operative question is not what the next statement will say but which document grants the permission and where it applies. Until a formal expansion is published, the nine places are the perimeter.
Related reading
- *Wholly Foreign-Owned Hospital Pilot and Private Healthcare Opening* (Article 227) — the earlier framing of the pilot within private healthcare policy.
- *Pharma and biotech opening moves from the foreign-investment action plan* (Article 405) — where the biotechnology pilot sits relative to hospitals.
Sources
- 商务部、国家卫生健康委、国家药监局·关于在医疗领域开展扩大开放试点工作的通知（2024-09-07）：https://www.mofcom.gov.cn/
- 国务院新闻办公室·”十五五”商务高质量发展有关情况新闻发布会（2026-10-22）：https://www.scio.gov.cn/live/2026/39833/index.html
- 中国政府网·国务院政策文件库：https://www.gov.cn/
- 国家卫生健康委员会·医疗机构管理条例及配套规章：https://www.nhc.gov.cn/
- 国家药品监督管理局·医疗器械注册与备案管理：https://www.nmpa.gov.cn/
外商独资医院扩大试点：九地名单、执业许可与尚未开放的部分
概述
一家境外医院集团看中国市场，会遇到两份文件，而阅读顺序决定了项目是否可行。第一份是外商投资准入负面清单，其中医疗机构仍属限制类。第二份是商务部、国家卫生健康委、国家药监局 2024 年 9 月 7 日印发的试点通知，允许在北京、天津、上海、南京、苏州、福州、广州、深圳和海南全岛设立外商独资医院。
2025 年 4 月，《独资医院领域扩大开放试点工作方案》施行，把试点地区、准入条件和经营范围落到操作层面。项目团队应当逐条研读的是这份工作方案，而不是 2024 年的通知本身。
2026 年 10 月没有新变化。2026 年 10 月 22 日，在国务院新闻办公室发布会上，商务部外国投资管理司负责人吴迪表示，将深化云计算、生物技术、独资医院等领域开放试点，释放服务业引资潜力。这是方向性表述：它没有为名单增加任何一个城市，是否扩围要看正式文件。按商务部数据，2025 年服务业占全国实际使用外资总额比重超过七成，这也是服务业反复出现在开放表述中的原因。
试点允许什么
许可范围很窄。外商独资医院可以设在九地之一，提供中医类以外的医疗服务，并且必须满足工作方案中的准入条件——这些条件涉及投资主体、选址、床位规模、科室设置和人员配备。
这项设计有两点容易被忽略。其一，许可与地点绑定：九地之外，负面清单的立场没有变化，企业不能拿着一张在上海取得的许可去成都开分院。其二，这是设立环节的许可，不是无限制经营：医院仍须取得任何医疗机构都需要的全部许可，还要取得下文所述的设备与药品审批。
经营范围应当尽早确定，因为它决定投资测算：综合医院、专科医院与外科中心，在科室、床位和人员上的要求并不相同，省级规则还可能附加本地条件。在可行性研究定稿之前取得关于拟设范围的书面确认，比在登记环节才发现不匹配要便宜得多。
两条硬边界
中医类除外。 排除是在中医类这一类别层面作出的。如果项目打算在综合医疗之外提供针灸、推拿或中医门诊，应当向省级卫生健康部门询问该排除对具体诊疗科目如何适用，而不是自行推定”西医院里的中医科不受限制”。
不含并购公立医院。 边界明确划在公立医院上。试点设想的路径是新建。对现有非公立医疗机构的其他参与方式，由工作方案和省级规则调整，宜作为问题向主管部门提出，而不宜当作已有定论。
还需说明一点：试点是在限制类行业内部开的口子，不是取消限制；写给总部的材料应当把这一点写清楚。
从设置批准到执业许可
外商独资医院是医疗机构，不是普通外商投资企业，办理顺序也体现了这一点。
第一步是设置审批，即《医疗机构管理条例》体系下的设置批准。申请提交至工作方案确定的层级，实践中为省级卫生健康行政部门，材料承载的是项目的实质内容：可行性研究报告、选址与建筑设计平面图、拟设床位、科室与人员、资金证明，以及外方投资者自身的资质文件。
第二步是执业登记，产出《医疗机构执业许可证》。许可证载明名称、地址、法定代表人、主要负责人、诊疗科目和床位。在许可证下发前接诊，不是可以排期的进度问题，而是无证执业。
第三步是主体层面。投资者的公司依外商投资法登记，并报送外商投资信息报告。医院执业许可与公司登记是两份由不同机关出具的文书，彼此不能替代。
与上述三步并行的，是跟着建筑和设备走的许可：大型医用设备配置许可、放射诊疗许可，以及环保与消防验收。这些合起来决定了关键路径。
三个误区
以为”独资”等于自由定价、自由引医。 非公立医疗机构的医疗服务价格实行市场调节价，不由政府定价；但一家希望取得医保定点的医院，要接受随之而来的支付标准、价格公示和费用控制要求，外籍医师也仍须办理各自的执业注册。股权结构改变不了这两项约束。
以为可以收购公立医院。 本试点下不可以。把交易结构设计成收购公立医疗机构，不能凭 2024 年的通知获得批准。
以为模式可以全国复制。 许可限于九地。多城市布局需要多城市的法律分析，而在多数城市，目前的答案仍是合资。
人员、设备、药品与支付
外籍医师在华执业须另行办理注册。短期行医需取得外国医师短期行医许可，有效期不超过一年；长期执业须取得中国医师资格并注册。有一处地区差异值得了解：按 2026 年 10 月 29 日公布的海南自由贸易港贸易便利化措施，外籍医师在海南的执业许可有效期由一年延长至三年。这是海南特有的安排，在测算海南机构人力成本时会用到。
进口医疗器械须取得国家药品监督管理局的注册或备案，大型设备在装机前须取得配置许可。进口药品须另行注册；临床急需少量进口的通道属于特定区域的安排，不在本试点范围内。
支付方面，医保定点在属地申请，并非自动取得。试点内的外商独资医院多数会走混合模式：核心业务以自费与商业保险直付为主，在本地规则和具体条件允许时申请定点。
涉及人类遗传资源的科研，其采集、保藏和对外合作须另行取得审批。
实务动作
- 先定城市，再读该市的实施细则。九地的执行并不一致。
- 与省级卫生健康部门建立预沟通渠道，取得关于拟设范围、床位规模和科室清单的书面确认。
- 外方资质文件办理公证认证，中文译本按受理机关的格式准备。
- 把器械注册与医师注册排到计划开业日之前倒推。决定关键路径的通常是注册周期，而不是施工。
- 向商务主管部门确认项目属于试点范围，并将该确认与支持外商投资信息报告的材料一并归档。
- 尽早与属地医保部门沟通定点事宜，因为这个答案决定的是收入模型，而不只是结算流程。
展望
方向是服务业进一步开放，医院被写进了这个方向。对具体项目而言，真正的问题不是下一句表态会说什么，而是哪份文件授予许可、许可适用于哪里。在正式扩围文件公布之前，九地就是边界。
延伸阅读
- 《外资独资医院试点与社会办医扩大开放》（第 227 篇）——试点在社会办医政策中的早期定位。
- 《外资行动方案中的医药与生物技术开放举措》（第 405 篇）——生物技术试点与医院试点的相对位置。
来源
- 商务部、国家卫生健康委、国家药监局·关于在医疗领域开展扩大开放试点工作的通知（2024-09-07）：https://www.mofcom.gov.cn/
- 国务院新闻办公室·”十五五”商务高质量发展有关情况新闻发布会（2026-10-22）：https://www.scio.gov.cn/live/2026/39833/index.html
- 中国政府网·国务院政策文件库：https://www.gov.cn/
- 国家卫生健康委员会·医疗机构管理条例及配套规章：https://www.nhc.gov.cn/
- 国家药品监督管理局·医疗器械注册与备案管理：https://www.nmpa.gov.cn/