- The “Pilot Work Plan for Expanding Opening in the Wholly Foreign-Owned Hospital Sector” (NHC, MOFCOM et al., Guowei Yizhengfa [2024] No. 36) permits wholly foreign-owned hospitals in nine provincial regions.
国家卫生健康委、商务部等四部门《独资医院领域扩大开放试点工作方案》（国卫医政发〔2024〕36号）允许在9个省市设立外商独资医院。- The pilot covers Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and all of Hainan, explicitly excluding TCM institutions and the acquisition of public hospitals.
试点范围涵盖北京、天津、上海、南京、苏州、福州、广州、深圳及海南全岛，明确排除中医类机构与并购公立医院。- Eligible hospitals are general, specialised or rehabilitation hospitals at tertiary level; blood-disease, psychiatric, infectious-disease and TCM hospitals are barred, and haematology is excluded from the practice scope.
符合条件的医院类别为综合医院、专科医院、康复医院且级别为三级；禁止设立血液病、精神病、传染病、中医医院，且诊疗科目不得登记血液内科。- Foreign and HK/Macao/Taiwan physicians may be employed short-term, but Chinese (mainland) personnel must make up at least 50% of both management and professional staff.
可按规定聘用外国及港澳台医师短期执业，但全院管理与卫生专业技术人员的中方（内地）人员占比均不得少于50%。- Approval sits with provincial health authorities (setting approval plus a five-year practice licence), with information systems connected to local regulatory platforms and data servers located in China.
设置审批与执业登记由省级卫生健康行政部门核发（执业许可证有效期5年），信息管理系统须接入属地监管平台，服务器位于境内。- The plan folds into a broader “orderly expansion of opening in the medical sector” and offers foreign investors a greenfield route distinct from the previous Sino-foreign joint-venture hospital model.
该方案属于”医疗领域有序扩大开放”整体部署，为外资提供区别于以往中外合资合作医院模式的新设独资路径。
Wholly Foreign-Owned Hospital Pilot and Private Healthcare Opening | 外资独资医院试点与社会办医扩大开放
Why this matters now
For foreign healthcare groups, China’s hospital market has long been accessible only through joint ventures or minority stakes under the Sino-foreign cooperative medical-institution framework. The late-2024 pilot to permit wholly foreign-owned hospitals changes that calculus: it creates a greenfield route for international operators to build and control a hospital on the mainland, bringing management models, clinical pathways and technology that complement the public system. The pilot is deliberately scoped — geographic, institutional and clinical guardrails are explicit — so the opportunity is real but bounded.
Market context: demand and the foreign-model case
The nine pilot regions are not arbitrary. They combine high openness, dense clusters of foreign enterprises and expatriates, and mature experience regulating foreign-funded medical institutions — exactly the conditions where demand for international-standard care is strongest. Foreign-invested hospitals are positioned to complement, not compete with, the public system: they target high-end and specialised demand, expatriate and cross-border patients, and technology- and service-model transfer that raises local standards. For provincial authorities, the pilot is also a service-environment upgrade that helps retain foreign talent and investment. The 50% mainland-personnel floor and the data-localisation duty, however, mean a foreign operator must build genuine local capability rather than merely import a brand. Realistic entrants therefore pair an international clinical franchise with a credible本地 workforce, IT and quality-system plan from day one.
The pilot framework
Issued by the National Health Commission, the Ministry of Commerce, the State Administration of Traditional Chinese Medicine and the National Disease Control and Prevention Administration (Guowei Yizhengfa [2024] No. 36, 1 November 2024), the plan authorises wholly foreign-owned hospitals in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and all of Hainan. TCM-category institutions are excluded, and acquiring public hospitals is not permitted. The nine regions were chosen for high openness, concentrated foreign enterprises and expatriates, and mature experience in regulating foreign-funded medical institutions.
Eligibility and operating conditions
The investor must be a legal person able to bear civil liability independently, with direct or indirect experience in healthcare investment and management, and must demonstrate international-leading management, models and equipment that supplement local supply. The hospital itself:
- may be for-profit or non-profit;
- must be a general, specialised or rehabilitation hospital at tertiary level — psychiatric, infectious-disease, blood-disease and TCM hospitals are prohibited;
- may not register haematology as a practice department; and
- may not conduct high-ethical-risk activities such as organ transplantation, assisted reproductive technology, prenatal screening/diagnosis, psychiatric inpatient care, or experimental cellular tumour therapies.
Foreign, HK/Macao and Taiwan physicians may be employed short-term, but Chinese (mainland) personnel must constitute at least 50% of both the management and the professional workforce. Information systems must connect to the local medical-service supervision platform, and electronic medical records and device data must be stored on servers located in China. Hospitals meeting medical-insurance rules may apply to join the designated insurance network and are encouraged to connect with domestic and international commercial health insurance.
Approval and supervision
Setting approval and practice registration are handled at the prefecture level for initial review and then by the provincial health authority, which issues the certificate of hospital establishment and the practice licence (valid five years, renewable). The licence is brought into the medical-quality safety-management system; hospitals are encouraged to participate in accreditation, and provincial and prefecture authorities conduct ongoing monitoring and coordinated supervision. Importantly, where the pilot conflicts with prior rules, the pilot plan prevails — giving it operative priority during the trial period.
Complementary openings across the medical sector
The hospital pilot is one move in a broader, sequenced opening of the healthcare and pharmaceutical sector. Around the same period, China removed or relaxed restrictions on foreign investment in several medical and aged-care sub-sectors, and the negative list has progressively shed items that previously capped foreign-invested enterprises in healthcare. Innovative-drug and medical-device access pathways have also been streamlined, and Greater Bay Area “medtech connexion” arrangements ease cross-boundary use of approved drugs and devices for residents. Read together, these signal a directional intent to let foreign capital and expertise enter where domestic supply is constrained or where international standards add value. Foreign groups should therefore map the hospital route against this wider roadmap — a hospital licence may pair naturally with device, pharma or senior-care ventures that share the same patient and regulatory ecosystem.
Practical steps for foreign investors
- Select a pilot region and confirm the hospital typology (general/specialised/rehabilitation, tertiary) against the exclusions.
- Prepare the investment and operating case showing international management, technology and capacity complementarity.
- Build the mainland workforce plan that satisfies the 50% Chinese personnel threshold across both management and clinical staff.
- Architect the IT and data posture — local servers, platform connectivity, and a data-governance stance consistent with China’s data-security and personal-information rules.
- Engage the provincial health authority early for the two-step approval, and plan for the five-year licence cycle and renewal.
Related reading
The hospital pilot sits inside a wider opening of the medical and pharmaceutical sector — from innovative-drug and device access to the negative list’s removal of certain restricted sub-sectors. Foreign groups should read the hospital route together with the broader healthcare-market-access roadmap.
外资独资医院试点与社会办医扩大开放
为何当下值得关注
对境外医疗集团而言，中国医院市场长期以来只能通过合资或少数股权路径进入（即中外合资合作医疗机构框架）。2024年底推出的”允许设立外商独资医院”试点改变了这一格局：它为国际运营方提供了一条在内地自主建设并控股医院的绿地路径，用以引入与公立医院体系互补的管理模式、临床路径与技术。该试点边界清晰——地理、机构与临床层面均设有明确护栏——因此机遇真实但有限定。
市场背景：需求与外资模式的逻辑
9个试点地区并非随意选取。它们兼具对外开放程度高、外资企业与外籍人员密集、监管外资医疗机构经验成熟等特征——恰恰是国际水准医疗需求最旺盛的条件。外商独资医院定位于与公立医院体系互补而非竞争：瞄准高端与专科需求、外籍及跨境患者，并以技术与管理模式转移提升本地标准。对省级政府而言，试点也是留住外资人才与投资的营商环境升级。但中方人员不少于50%与数据本地化义务，意味着外资运营方须建设真实的本地能力，而非仅引入品牌。务实的进入者因此从第一天起就将国际临床品牌与可信的本地人才、IT与质量体系计划相配对。
试点框架
由国家卫生健康委、商务部、国家中医药局、国家疾控局联合印发（国卫医政发〔2024〕36号，2024年11月1日），方案授权在北京、天津、上海、南京、苏州、福州、广州、深圳以及海南全岛设立外商独资医院。明确排除中医类机构，且不允许并购公立医院。选取这9个省市，是因为其对外开放程度高、外资企业与外籍人员集中，且积累了丰富的外资医疗机构管理经验。
资质与运营条件
境外投资者须为能够独立承担民事责任的法人，具有直接或间接医疗卫生投资与管理经验，并能提供国际先进的管理理念、模式与服务，以及国际领先的技术与设备，以补充或改善当地医疗服务能力。医院本身须满足：
- 经营性质可为营利性或非营利性；
- 类别为综合医院、专科医院、康复医院且级别为三级——禁止设立精神病、传染病、血液病、中医医院；
- 诊疗科目不得登记血液内科；
- 不得开展人体器官移植、人类辅助生殖、产前筛查与诊断、精神科住院治疗、肿瘤细胞治疗新技术试验性治疗等伦理风险较高的诊疗活动。
可按规定聘用外国及港澳台医师短期执业，但中方（内地）人员须占全院管理与卫生专业技术人员的均不少于50%。信息管理系统须接入属地医疗服务监管平台，电子病历与医用设备等信息存储服务器须位于中国境内。符合医保规定的医院可按程序申请纳入医保定点，并鼓励对接国内外商业健康保险。
审批与监管
设置审批与执业登记由地市级卫生健康行政部门初审、省级卫生健康行政部门核发设置医疗机构批准书与医疗机构执业许可证（有效期5年，期满可续）。医院纳入医疗质量安全管理范畴，鼓励参加医院评审评价，省级与地市级部门开展动态监测与协同监管。值得注意的是，原有规定与本试点方案不符的，以本方案为准——在试点期内具有操作优先性。
医疗行业更广维度的配套开放
医院试点只是医疗与医药行业有序、分批扩大开放中的一步。同一时期，中国在多个医疗与养老子行业取消或放宽了外资准入限制，负面清单也逐步删除了此前约束医疗卫生领域外商投资企业的条目。创新药与医疗器械准入路径同步简化，粤港澳大湾区”港澳药械通”等安排也便利了居民跨境使用已获批药品与器械。综合来看，这些举措释放出允许外资与专长进入供给受限或国际标准的确能增值领域的导向性意图。外资集团因此应将医院路径置于更宏观的路线图中研判——一张医院牌照可能天然与共享同一患者与监管生态的器械、药品或养老业务协同。
外资投资者实务步骤
- 选定试点地区，并对照排除项确认医院类型（综合/专科/康复，三级）。
- 准备投资与运营方案，论证国际管理、技术与能力互补性。
- 构建内地人才计划，满足管理与临床中方人员均不少于50%的要求。
- 设计IT与数据架构——境内服务器、平台对接，以及与数据安全、个人信息保护规则一致的数据治理立场。
- 尽早对接省级卫生健康行政部门完成两步审批，并规划5年证照周期与续期。
延伸阅读
医院试点位于医疗与医药行业更广开放版图之中——从创新药与医疗器械准入，到负面清单取消若干受限子行业。外资集团应将医院路径与更宏观的医疗服务市场准入路线图一并研读。
Sources
- 国家卫生健康委、商务部、国家中医药局、国家疾控局：《独资医院领域扩大开放试点工作方案》（国卫医政发〔2024〕36号）— https://www.gov.cn/zhengce/zhengceku/202411/content_6990279.htm