All posts by adm0n

Healthcare & Pharma / 医药医疗

Guangdong’s International Medical Services Pilot: Foreign-Patient Growth, Wholly Foreign-Owned Hospitals and What It Means for Healthcare Investors

  • At the 17 August 2026 press conference marking China’s Doctors’ Day, Guangdong’s health commission reported that visits by foreign patients at the 25 pilot international-medical-service hospitals grew 95.6% year on year since the pilot launched in February 2026.
    2026 年 8 月 17 日广东医师节新闻发布会上，省卫健委通报：自 2026 年 2 月国际医疗服务试点启动以来，25 家试点医院外籍人士就医人次同比增长 95.6%。
  • Hong Kong University-Shenzhen Hospital, one of the 25 pilots, has treated patients from 129 countries and regions and served 720,000 foreign patients in the past three years; in 2026 its international medical centre business grew 17.8% year on year from January to July.
    试点之一的香港大学深圳医院已接诊来自 129 个国家和地区的患者，近三年服务境外患者 72 万人次；2026 年 1—7 月其国际医疗中心业务量同比增长 17.8%。
  • Guangdong is accelerating wholly foreign-owned hospital pilots in Guangzhou and Shenzhen: six projects have reached landing intention and three have passed setting approval.
    广东正加快推进广州、深圳外商独资医院试点：已有 6 家项目达成落地意向，其中 3 家已通过设置审批。
  • Internationally oriented services are charged by the patient or their international commercial insurance, outside the basic medical insurance reimbursement scope, following international medical standards, processes and payment models.
    国际医疗服务按国际通行医疗技术标准、服务流程、管理体系和支付模式运营，费用由患者自付或国际商业保险支付，不纳入基本医保报销。
  • Guangzhou launched an international medical tourism service centre in April, issued 12 support measures, and in August released a cross-border insurance settlement platform enabling one-stop no-advance-payment settlement for foreign patients.
    广州 4 月揭牌国际医疗旅游服务中心并发布 12 条支持措施，8 月上线国际医疗跨境支付平台，实现境外患者就医免垫付一站式结算。
  • At national level, the National Health Commission confirmed in August that a second batch of wholly foreign-owned hospital pilot cities is being selected and that high-end specialist medical, rehabilitation and nursing are now in the encouraged catalogue nationwide.
    国家层面，国家卫生健康委 8 月确认正遴选第二批外商独资医院试点城市，并将高端专业医疗、康复、护理纳入全国鼓励范围。

Guangdong’s International Medical Services Pilot: Foreign-Patient Growth, Wholly Foreign-Owned Hospitals and What It Means for Healthcare Investors | 广东国际医疗服务试点：外籍患者增长、外商独资医院与医疗投资者的机会

The pilot and its early results

On 17 August 2026 the Guangdong Provincial Health Commission held its press conference for China’s Doctors’ Day and released the first substantive data on the province’s international medical services pilot. The pilot began in February 2026 when the provincial health commission, the medical security bureau and the drug administration jointly announced the first batch of 25 pilot hospitals, including Guangdong Provincial People’s Hospital, the First Affiliated Hospital of Sun Yat-sen University, Hong Kong University-Shenzhen Hospital and Zhuhai People’s Hospital. Since the launch, visits by foreign patients to the international and special-need medical departments of the 25 hospitals grew 95.6% year on year. The business model is explicitly international: services follow internationally accepted medical technical standards, service processes, management systems and payment models, targeting residents of Hong Kong, Macao and Taiwan, foreign nationals and overseas Chinese who pay out of pocket or through international commercial insurance, outside the scope of basic medical insurance reimbursement.

The scale and shape of demand

The pilot data show a large and growing cross-border patient pool. HKU-Shenzhen Hospital has treated patients from 129 countries and regions and served 720,000 foreign patients over three years; since joining the pilot, its international medical centre business grew 17.8% year on year in January–July 2026, with outpatient and check-up volumes up 16.4% and discharges up 33.5%, and Hong Kong patients accounting for 30% of outpatient and 20% of inpatient volumes. Guangdong’s position in the Greater Bay Area gives it a unique catchment: cross-border commuting workers, Hong Kong and Macao residents, and a deep stock of manufacturing-linked expatriate communities across the Pearl River Delta. For healthcare investors, the demand signal is that international-standard care priced outside the public insurance pool is a viable commercial segment in Guangdong, not a marginal one.

Wholly foreign-owned hospital acceleration

The most important development for foreign investors is the acceleration of wholly foreign-owned hospital pilots in Guangzhou and Shenzhen. Guangdong’s health commission reported that six projects have reached landing intention and three have passed setting approval. This follows the national framework: the September 2024 pilot notice and the November 2024 Plan for Expanding the Wholly Foreign-Owned Hospital Pilot, which set the conditions, requirements and procedures, and under which four wholly foreign-owned hospitals have already landed in Tianjin, Shanghai, Boao and Fuzhou. The National Health Commission confirmed in August 2026 that it is selecting a second batch of pilot cities, expanding from “point pilots” to regional rollout, and that the encouraged catalogue for foreign investment (2025 edition) now includes high-end specialist medical, rehabilitation and nursing nationwide. For a foreign hospital operator, Guangdong’s Guangzhou and Shenzhen are the most active frontier.

The stem-cell and gene-technology opening

A further dimension of the medical opening is technological. The National Health Commission confirmed in August 2026 that, in the Beijing, Shanghai and Guangdong free trade zones and the Hainan Free Trade Port, foreign-invested enterprises are permitted to conduct R&D and application of human stem-cell and gene-diagnosis and therapy technologies for the purpose of product registration and marketing, with approved products usable nationwide. For foreign biotech and cell-therapy companies, this converts the FTZ and Hainan pilots into a route to develop, register and market advanced therapies in China — subject to the full regulatory chain of human genetic resource administration, clinical trials (including international multicentre trials), drug registration and production licensing and ethics review. This is a significant expansion of the addressable market for foreign cell and gene therapy developers.

Guangzhou’s ecosystem building

Beyond the hospital pilots, Guangzhou is building the surrounding service ecosystem. In April 2026 the Guangzhou International Medical Tourism Service Centre was inaugurated, integrating the resources of 17 pilot hospitals in the city with the cultural-tourism and exhibition group; on the same day the city health commission issued 12 support measures for international medical services covering benchmark projects, resource clustering, talent attraction, payment convenience and TCM internationalisation. In August 2026, at the international medical innovation exchange and the Guangzhou Medical and Health Industry Expo, the Guangzhou Hospital Association’s International Medical Services Management Branch was established — the first industry management platform of its kind in the city — and a cross-border medical payment platform was released, enabling one-stop settlement for foreign patients without out-of-pocket advance payments through bank and insurer coordination. The city reports that foreign patients now come from 133 countries and regions, up from 90-plus before the tourism service centre opened, and that foreign patient volumes grew over 30% in the first half of the year to 260,000.

Practical guidance for healthcare investors

First, assess the pilot structure: wholly foreign-owned hospital entry requires setting approval, hospital licensing and alignment with the 2024 pilot conditions; the accelerated pace in Guangzhou and Shenzhen means the window is now. Second, understand the payment model: international services sit outside basic insurance, so pricing, insurance networks and cross-border settlement platforms are the commercial core. Third, for cell and gene therapies, evaluate the FTZ route in Guangdong (or Beijing, Shanghai, Hainan) for R&D and registration, and map the full regulatory chain early. Fourth, consider partnership with the 25 pilot hospitals — many are state-owned and are building international departments and tourism-service links, which offers a lighter entry than greenfield ownership. Fifth, monitor the second batch of pilot cities nationally and the encouraged-catalogue benefits (import duty, land, tax) that attach to encouraged categories. The Guangdong data prove the demand; the policy framework proves the intent; the remaining question for investors is execution speed and structure.

Outlook

Guangdong’s international medical pilot is the clearest demonstration yet that China’s healthcare opening has moved from policy text to commercial reality. Foreign-patient growth of nearly double in six months, wholly foreign-owned hospitals passing setting approval in Guangzhou and Shenzhen, a cross-border payment platform in operation and a provincial data trail — each of these would have been difficult to imagine two years ago. For foreign healthcare and biotech investors, the region is now a serious candidate for first entry into China’s mainstream private healthcare market.

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广东国际医疗服务试点：外籍患者增长、外商独资医院与医疗投资者的机会

试点与早期成果

2026 年 8 月 17 日，广东省卫生健康委员会举行第九个中国医师节新闻发布会，公布国际医疗服务试点首批实质性数据。试点始于 2026 年 2 月，省卫健委、省医保局、省药监局联合公布首批 25 家试点医院名单，包括广东省人民医院、中山大学附属第一医院、香港大学深圳医院、珠海市人民医院等。启动以来，25 家医院国际医疗和特需医疗板块外籍人士就医人次同比增长 95.6%。业务模式明确国际化：按国际通行的医疗技术标准、服务流程、管理体系和支付方式运营，面向港澳台居民、外籍人士、海外华人等自费或持有国际商业保险的人群，费用不纳入基本医保报销。

需求的规模与形态

试点数据显示庞大且增长的跨境患者池。港大深圳医院已接诊来自 129 个国家和地区的患者，近三年服务境外患者 72 万人次；纳入试点后，2026 年 1—7 月国际医疗中心业务量同比增长 17.8%，门急诊和体检业务量增长 16.4%，出院量增长 33.5%，香港患者门急诊占比 30%、住院占比 20%。广东在大湾区的位置带来独特客源：跨境通勤人群、港澳居民、以及珠三角制造业沉淀的庞大外派社区。对医疗投资者，需求信号是：定价在公共医保池之外的国际标准医疗服务，在广东是可行的商业细分，而非边缘。

外商独资医院提速

对外国投资者最重要的进展是广州、深圳外商独资医院试点的加快。广东省卫健委通报，已有 6 家项目达成落地意向，其中 3 家已通过设置审批。这延续全国框架：2024 年 9 月开放试点通知与 2024 年 11 月《独资医院领域扩大开放试点工作方案》设定条件、要求与程序，首批 4 家外商独资医院已在天津、上海、博鳌、福州落地。国家卫生健康委 2026 年 8 月确认正遴选第二批试点城市，从”点状试点”向”区域推广”拓展；《鼓励外商投资产业目录（2025 年版）》已把高端专业医疗、康复、护理纳入全国鼓励范围。对外国医院运营者，广东的广州、深圳是最活跃的前沿。

干细胞与基因技术的开放

医疗开放的另一个维度是技术层面。国家卫生健康委 2026 年 8 月确认，在北京、上海、广东自贸试验区和海南自由贸易港，允许外商投资企业从事人体干细胞、基因诊断与治疗技术开发和应用，以用于产品注册上市和生产，经注册上市和批准生产的产品可在全国使用。对外国生物技术与细胞治疗企业，这使自贸试验区与海南试点转化为在中国开发、注册与上市先进疗法的路径——前提是走完整监管链：人类遗传资源管理、临床试验（含国际多中心临床试验）、药品注册上市、生产许可与伦理审查。这是外国细胞与基因治疗开发商可及市场的重大扩展。

广州的生态建设

在医院试点之外，广州正在建设周边服务生态。2026 年 4 月，广州国际医疗旅游服务中心揭牌，联动全市 17 家试点医院资源与文旅会展集团；同日市卫健委发布 12 条支持国际医疗服务创新举措，覆盖标杆打造、资源集聚、人才引育、支付便利与中医药国际化。2026 年 8 月，在国际医疗创新发展交流会暨广州医疗与健康产业博览会上，广州市医院协会国际医疗服务管理分会成立——全市首个专注国际医疗服务的行业管理平台——并发布国际医疗跨境支付平台，经政府、银行与保险机构协调实现境外患者就医免垫付一站式结算。广州报告境外患者来源地已从服务中心成立前的 90 多个国家和地区升至 133 个，上半年境外患者增长超 30%、达 26 万人次。

医疗投资者实操指引

其一，评估试点结构：外商独资医院进入须通过设置审批、医疗机构执业登记并符合 2024 年试点条件；广州、深圳提速意味着窗口期就在当下。其二，理解支付模式：国际服务在基本医保之外，定价、保险网络与跨境结算平台是商业核心。其三，细胞与基因疗法：评估广东（或北京、上海、海南）自贸试验区研发与注册路径，尽早梳理完整监管链。其四，考虑与 25 家试点医院合作——多数为公立，正在建设国际部与旅游服务链接，比绿地自有更轻的进入方式。其五，关注全国第二批试点城市与鼓励目录红利（进口关税、用地、税收）。广东数据证明了需求，政策框架证明了意图，留给投资者的问题是执行速度与结构。

展望

广东国际医疗试点是中国医疗开放从政策文本走向商业现实迄今最清晰的例证。六个月内外籍患者近翻倍增长、广州深圳外商独资医院通过设置审批、跨境支付平台投入运营、省级数据链条成形——每一项在两年前都难以想象。对外国医疗与生物科技投资者，该区域现已成为进入中国主流私立医疗市场的严肃首选地。

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Healthcare & Pharma / 医药医疗

Segmented Pharmaceutical Production in China: A New Manufacturing Option for Foreign MAHs

  • On 15 May 2026 the revised Implementation Regulations of the Drug Administration Law took effect, with Article 32 expressly allowing segmented (split-site) production of qualifying innovative drugs under a unified quality-assurance system.
    2026年5月15日，新修订的《药品管理法实施条例》施行，其中第三十二条明确允许符合条件的创新药在统一质量保证体系下分段委托生产。
  • The State Drug Administration has separately worked on biological-product segmented production; the 2026 Action Plan to Stabilise and Optimise Foreign Investment now calls for detailed rules for cross-border segmented production of both biologicals and chemical drugs.
    国家药监局已就生物制品分段生产单独发文推进；2026年《利用外资固稳促优行动方案》进一步提出研究出台药品分段生产实施细则，便利境外药品上市许可持有人开展生物制品、化学药品跨境分段生产。
  • Segmented production applies to innovative drugs with special production-process or facility requirements, clinically urgent drugs, and drugs needed for public-health emergencies, as designated by the State Council.
    分段生产适用于生产工艺、设施设备有特殊要求的创新药，临床急需的药品，以及突发公共卫生事件急需或储备需要的药品等国务院规定情形。
  • The marketing authorisation holder (MAH) remains the single, final quality-responsible party and must build a unified quality-assurance system spanning all production sites.
    药品上市许可持有人（MAH）仍是唯一、最终的质量责任主体，必须建立覆盖药品生产全过程和全部生产场地的统一质量保证体系。
  • For foreign MAHs, the combination of segmented production and the FIE action plan opens a path to structure cross-border biologics and chemical manufacturing while keeping Chinese regulatory responsibility centralised.
    对外资MAH而言，分段生产与稳外资行动方案的组合，为跨境生物制品与化学药品生产布局开辟了路径，同时保持中国监管责任集中化。
  • Commercial insurers are also being encouraged to cover more innovative drugs and devices, and foreign-made drugs gain smoother entry into retail channels.
    政策同时鼓励保险公司将更多创新药械纳入商业保险保障范围，并便利外资企业生产的药品进入药品零售渠道。

Segmented Pharmaceutical Production in China: A New Manufacturing Option for Foreign MAHs | 中国药品分段生产：外资上市许可持有人的制造新选项

Why this matters now

Pharmaceutical manufacturing has traditionally meant one site, one product, one end-to-end process. China’s 2026 regulatory wave is deliberately unpicking that assumption. On 15 May 2026, the revised Implementation Regulations of the Drug Administration Law took effect, and Article 32 explicitly permits the segmented production of qualifying innovative drugs — where manufacturing steps run at different sites and potentially through different companies — as long as the marketing authorisation holder maintains a unified quality-assurance system. The move is paired with an explicit signal to foreign investors: the June 2026 Action Plan to Stabilise and Optimise Foreign Investment (issued by MOFCOM, NDRC and MOF) commits to detailed rules for cross-border segmented production of biological products and chemical drugs, building on the earlier biological-product segmented-production pilot. For a global pharma company with an approved innovative molecule, this changes how production for the Chinese market can be structured.

What segmented production covers

Article 32 of the revised Implementation Regulations permits segmented production for three categories: innovative drugs whose production process, equipment or facilities have special requirements; clinically urgent drugs requested by relevant State Council departments; and drugs needed for emergency response or stockpiling. The MAH may commission qualified production enterprises to handle separate production steps. Critically, the law does not decentralise responsibility: the MAH must establish a unified quality-assurance system covering the entire production process and all production sites, and remains the single final responsible party for product quality. The State Drug Administration’s inspection guidance for biological-product segmented production further requires the MAH to align quality-management systems across segment producers, apply quality-risk management to contamination and cross-contamination risks, and ensure the quality authorisation holder can base final release decisions on a full review of data from all segments.

The foreign-investment angle

The FIE Action Plan published in June 2026 explicitly says the authorities will move quickly to issue implementation rules for segmented production, to facilitate overseas drug marketing authorisation holders in carrying out cross-border segmented production of biologicals and chemical drugs. This is the first time the policy explicitly opens the door to cross-border arrangements — a Chinese plant handling one production step, an overseas site another. For foreign MAHs, the practical attraction is manufacturing flexibility: an API or biologic intermediate can be produced at the site with the best economics and IP-protection profile, with final formulation and packaging in China, while quality oversight remains anchored in one unified system. The same plan adds supporting measures: expanding the pilot scope for biotechnology and wholly foreign-owned hospitals, encouraging commercial insurers to cover more innovative drugs and devices, and easing foreign-made drugs into retail pharmacy channels.

Practical steps for foreign MAHs

  1. Map your portfolio. Identify molecules that qualify for segmented production — innovative drugs with special process or facility needs, clinically urgent products, or emergency/stockpile candidates.
  2. Decide the China anchor. Choose which production step will be performed in China and by which qualified manufacturer, and where the MAH quality-authorisation function will sit.
  3. Design the unified quality system. Draft the single quality-assurance framework covering all sites and segments, including technology transfer, change control, deviation handling and CAPA procedures.
  4. Engage the SDA early. Because implementation rules for chemical cross-border segmented production are still being drafted, use pre-submission consultation channels to align on expectations before committing investment.
  5. Review supply-chain economics. Model the tax, customs and logistics treatment of intermediates moving across borders, including bonded and duty-free options where available.
  6. Coordinate with insurance and retail access. Plan for how the product will reach patients — commercial insurance coverage and retail channel entry both affect market-access planning.

Risks and compliance notes

Segmented production is a permission, not a relaxation. The MAH’s single-responsibility rule means a failure at any segment is ultimately the MAH’s failure; contract manufacturers’ systems must be auditable and aligned. Foreign MAHs should also track the still-evolving implementation rules for chemical cross-border segmented production — until they issue, cross-border arrangements for small-molecule drugs should be structured conservatively. IP protection of process know-how across borders, GMP consistency between sites, and batch-release responsibilities all need contractual precision. Finally, the SDA’s on-site inspection and post-market supervision powers are unchanged, so documentation and traceability must satisfy the same standards as single-site production.

中国药品分段生产：外资上市许可持有人的制造新选项

为什么当下重要

药品生产传统上意味着”一个场地、一个产品、一条端到端流程”。中国2026年的监管浪潮正有意拆解这一假设。2026年5月15日，新修订的《药品管理法实施条例》施行，第三十二条明确允许符合条件的创新药分段生产——即制造环节在不同场地、甚至经由不同公司运行——只要上市许可持有人维护统一质量保证体系。该举措与对外资投资者的明确信号相配合：2026年6月商务部、国家发展改革委、财政部发布的《利用外资固稳促优行动方案》承诺研究出台生物制品与化学药品跨境分段生产实施细则，在早期生物制品分段生产试点基础上推进。对拥有获批创新分子的全球制药企业而言，这改变了中国市场的生产布局方式。

分段生产覆盖哪些情形

修订后《实施条例》第三十二条允许三类药品分段生产：生产工艺、设施设备有特殊要求的创新药；国务院有关部门提出的临床急需药品；以及应对突发公共卫生事件急需或储备需要的药品。MAH可以委托符合条件的生产企业承担不同生产步骤。关键在于，法律并未分散责任：MAH必须建立覆盖药品生产全过程和全部生产场地的统一质量保证体系，并作为产品质量唯一且最终的责任主体。国家药监局生物制品分段生产现场检查指南进一步要求MAH使各分段生产企业的质量管理体系有效衔接与统一，运用质量风险管理方法识别控制污染、交叉污染及差错风险，并确保质量受权人能基于对各分段数据的全面审核作出最终放行决定。

外资维度

2026年6月发布的稳外资行动方案明确提出，抓紧研究出台药品分段生产实施细则，便利境外药品上市许可持有人开展生物制品、化学药品跨境分段生产。这是政策首次明确为跨境安排敞开大门——中国工厂承担一个生产步骤，海外场地承担另一个。对外资MAH而言，实际吸引力在于制造灵活性：原料药或生物制品中间体可在经济性与知识产权保护最优的场地生产，最终制剂与包装放在中国，而质量监督仍锚定于一个统一体系。同一方案还附带了配套措施：扩大生物技术、外商独资医院开放试点区域范围，支持保险公司将更多创新药械纳入商业保险，并便利外资企业生产的药品进入零售药店渠道。

外资MAH的操作步骤

  1. 梳理产品组合。 识别符合分段生产条件的分子——生产工艺或设施有特殊要求的创新药、临床急需产品或应急／储备候选品。
  2. 确定中国锚点。 选择哪个生产步骤在中国、由哪家合格生产商执行，以及MAH质量受权职能设在何处。
  3. 设计统一质量体系。 起草覆盖全部场地与分段的单一质量保证框架，包括技术转移、变更控制、偏差处理与CAPA程序。
  4. 尽早与国家药监局沟通。 由于化学药品跨境分段生产实施细则仍在起草中，在投入投资前应利用预沟通渠道对齐预期。
  5. 审查供应链经济性。 建模中间体跨境流动的税收、海关与物流处理，在可行时考虑保税与免税选项。
  6. 协同保险与零售准入。 规划产品如何触达患者——商业保险覆盖与零售渠道进入都影响市场准入规划。

风险与合规提示

分段生产是许可，不是放松。MAH单一责任规则意味着任何分段的失败最终都是MAH的失败；合同生产商的体系必须可审计、可对齐。外资MAH还应跟踪仍在制定的化学药品跨境分段生产实施细则——在细则出台前，小分子药物跨境安排应保守设计。跨境工艺know-how的知识产权保护、场地间GMP一致性、批次放行责任都需要合同上的精确性。最后，药监局现场检查与上市后监管权限不变，因此文档与可追溯性必须满足与单一场地生产相同的标准。

Sources

  • 商务部 国家发展改革委 财政部《利用外资固稳促优行动方案》（商资发〔2026〕97号）——第三条”支持外资参与医药等产业高质量发展”（研究出台药品分段生产实施细则、便利境外MAH跨境分段生产）：https://sxdofcom.shaanxi.gov.cn/fdi/yhzc/40265.jhtml
  • 商务部副部长凌激出席国新办发布会介绍利用外资固稳促优有关政策措施（王亚回应医药开放措施，生物制品分段生产试点、化学药品跨境分段生产细则）：https://swj.wulanchabu.gov.cn/zxft/1994919.html
  • 中国医药创新促进会《药品管理法实施条例大家谈 在鼓励创新与严守底线间找到平衡》（第三十二条分段生产、MAH统一质量保证体系解读）：https://www.phirda.com/artilce_43447.html
  • 山西省民营经济发展局官网《外资企业可重点关注哪些扩大准入领域？》（2026-08-10，摘自商资发〔2026〕97号：药品分段生产、生物技术和外商独资医院领域扩大开放）：https://myj.shanxi.gov.cn/ztzl/bwbd/lywzgw/202608/t20260810_10196322.shtml
Healthcare & Pharma / 医药医疗

Wholly Foreign-Owned Hospital Pilot and Private Healthcare Opening

  • 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

  1. Select a pilot region and confirm the hospital typology (general/specialised/rehabilitation, tertiary) against the exclusions.
  2. Prepare the investment and operating case showing international management, technology and capacity complementarity.
  3. Build the mainland workforce plan that satisfies the 50% Chinese personnel threshold across both management and clinical staff.
  4. 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.
  5. 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

  1. 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）。
  2. 准备投资与运营方案，论证国际管理、技术与能力互补性。
  3. 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。
  4. 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。
  5. 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
Healthcare & Pharma / 医药医疗

Foreign-invested hospitals: the 2026 liberalisation and where they can land

  • Wholly-foreign-owned hospitals are piloted in nine regions — Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and Hainan island — under the Nov-2024 pilot plan; outside those areas foreign-invested hospitals remain equity or cooperative joint ventures.
    外商独资医院在九地试点——北京、天津、上海、南京、苏州、福州、广州、深圳及海南全岛——依 2024 年 11 月试点方案；试点外外资办医仍以合资/合作形式为主。
  • China’s first wholly-foreign-owned tertiary general hospital — Tianjin Pengruili Hospital — opened on 26 February 2025 with about ¥1 billion invested and 500 beds, after Tianjin issued the first such licence on 16 December 2024.
    中国首家外商独资三级综合医院天津鹏瑞利医院于 2025 年 2 月 26 日开诊，投资约 10 亿元、设 500 张床位；天津于 2024 年 12 月 16 日颁发首张该类执业许可证。
  • The 2026 action plan commits to further expanding the biotech and wholly-foreign-owned-hospital pilot regions after evaluating the initial rollout, signalling that more cities will be added.
    2026 年行动方案承诺在评估初期落地情况后进一步扩大生物技术及外商独资医院试点区域，预示更多城市将加入。
  • The Jan-2026 “nine-city services-opening” comprehensive pilot assigned 159 tasks (103 common plus 3 added) spanning medical-senior-care opening, telecom and finance — extending the policy floor beyond the nine hospital-pilot regions.
    2026 年 1 月”9 城市服务业扩大开放”综合试点部署 159 项任务（103 项共性加 3 项新增），覆盖医疗康养开放、电信、金融等，将政策底盘扩展至九个医院试点区域之外。
  • As of end-2025 a batch of wholly-foreign-owned hospitals had been approved, joining the 60-plus foreign-invested (mostly joint-venture) medical institutions already operating in China.
    截至 2025 年底，一批外商独资医院已获批，叠加中国已有的 60 余家外资（多为合资）医疗机构。
  • Practical constraints are real for foreign investors: TCM is excluded, public-hospital mergers are barred, and human-genetic-resource and data-export rules still apply — so JV and greenfield WFOE each carry trade-offs.
    外资办医仍有实质约束：不含中医类、不含并购公立医院，且人类遗传资源与数据出境规则仍适用——故合资或绿地独资各有权衡。

Foreign-invested hospitals: the 2026 liberalisation and where they can land | 2026 外资办医政策松绑与落地城市

Overview

Healthcare services are among the last major service sectors where foreign access remains conditional in China, but 2024–2026 has brought the most significant opening in a generation. The centrepiece is a pilot that, for the first time, permits wholly-foreign-owned hospitals in nine designated regions, alongside a long-standing joint-venture route that remains available nationwide. The 2026 “Stabilising and Improving Foreign Investment” action plan then commits to widening the pilot further.

This article traces the liberalisation timeline, the nine pilot regions and why they were chosen, the landing cases already on the ground, the joint-venture baseline, and the practical constraints and steps a foreign investor should plan around. It is informational guidance, not regulatory or legal advice.

The liberalisation timeline (2024–2026)

  • September 2024 — three-ministry medical pilot notice. The Ministry of Commerce, the National Health Commission (NHC) and the NMPA issued a notice opening pilot measures in healthcare. In biotech, foreign-invested enterprises were allowed, in the Beijing, Shanghai and Guangdong free-trade zones and the Hainan Free Trade Port, to conduct human stem-cell, gene-diagnosis and gene-therapy technology development and application for product registration and production. In the hospital field, the notice proposed allowing wholly-foreign-owned hospitals in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and Hainan island (TCM excluded; no merger of public hospitals).
  • 1 November 2024 — negative list clears manufacturing. The 2024 negative list took effect, removing the last manufacturing-sector foreign-access restrictions. While hospitals are a service sector, this signalled the broader opening direction and eased ancillary manufacturing (e.g. devices, supplies) for foreign healthcare investors.
  • November 2024 — the WFOE-hospital pilot plan. The NHC, MOFCOM, the National Administration of Traditional Chinese Medicine and the China CDC published the *Pilot Work Plan for Expanding Opening in the Wholly-Foreign-Owned Hospital Field*, formalising the nine-region pilot and the exclusions.
  • January 2026 — nine-city services-opening pilot. MOFCOM issued the comprehensive services-opening pilot tasks for nine cities (led by Dalian), assigning 159 tasks — 103 common tasks plus 3 added — covering medical-senior-care opening, telecom, finance and more, broadening the policy floor well beyond the nine hospital-pilot regions.
  • June 2026 — action plan expansion signal. The State Council information office briefing on the “Stabilising and Improving Foreign Investment” action plan confirmed the biotech pilot covers the Beijing, Shanghai and Guangdong FTZs plus Hainan, and the wholly-foreign-owned-hospital pilot covers the nine regions; it committed to studying a further expansion of these pilot geographies after evaluating the initial rollout.

The nine pilot regions and why

The nine are Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and Hainan island. The NHC’s stated rationale is practical. First, demand: these are high-openness, foreign-enterprise- and expatriate-dense locations with stronger multi-tiered healthcare demand. Second, governance maturity: since the 2000 *Interim Measures for Sino-Foreign Equity/Cooperative Medical Institutions*, a sizable share of Sino-foreign medical institutions have clustered in exactly these provinces, building regulatory experience. Third, investment weight: these regions account for over 45% of actual utilised foreign capital, making them natural magnets for hospital investment.

Landing cases already on the ground

  • Tianjin Pengruili Hospital — the flagship. On 16 December 2024 Tianjin issued the first wholly-foreign-owned tertiary general hospital licence; the hospital opened on 26 February 2025. Invested by Singapore’s Pengruili (Perennial) Group at about ¥1 billion with 500 beds, it offers broad specialties plus an international department for customised and chronic-disease management, and sits inside the Tianjin South Station health-city TOD complex.
  • Guangzhou — rehab and a tertiary general plan. A Guangzhou development zone partnership with Pengruili is building the city’s first wholly-foreign-owned specialty hospital (a rehabilitation hospital) expected to open by end-2026; a separate Baiyun district project (Phase-I ¥1 billion) is planned as South China’s first wholly-foreign-owned tertiary general hospital.
  • Hainan — timed to the FTP seal. On the day of the Hainan Free Trade Port’s “sealing” at end-2025, a Pengruili-invested wholly-foreign-owned rehabilitation hospital was established there.
  • Scale of the base. As of end-2025, a batch of wholly-foreign-owned hospitals had been approved, joining the 60-plus foreign-invested medical institutions (mostly joint ventures) already operating across China.

The joint-venture baseline (still nationwide)

Wholly-foreign-owned hospitals are a pilot privilege confined to nine regions. Outside them, foreign healthcare investment continues under the 2000 *Interim Measures*, which permit Sino-foreign equity or cooperative medical institutions subject to provincial/municipal health-commission approval. This JV route remains the workhorse for foreign groups that want a China footprint outside the pilot geographies, or that prefer a local partner for land, staffing and payer relationships. Many of the 60-plus existing foreign medical institutions are JVs, and they provide a proven template: foreign capital plus a Chinese partner navigating licensing, staffing and hospital-administration rules.

Practical constraints foreign investors must respect

The opening is real but bounded. Key guardrails:

  • TCM excluded. Wholly-foreign-owned hospitals may not be traditional Chinese-medicine institutions.
  • No public-hospital M&A. The pilot explicitly bars acquiring or merging public hospitals.
  • Human genetic resources. Hospitals engaging in research involving human genetic resources remain subject to HGR approval and compliance — a live constraint for internationally linked groups running trials or biobanks.
  • Data export and cybersecurity. Cross-border transfer of patient or research data must satisfy PIPL and cybersecurity/important-data rules; groups with regional or global data lakes need a compliant architecture.
  • Licensing and staffing. A 医疗机构执业许可证 from the competent health commission is mandatory, and foreign-trained physicians must meet PRC practice-qualification requirements.

What foreign investors should do next

  • Pick the structure by geography. Use the WFOE route only inside the nine pilot regions; elsewhere plan a JV under the 2000 measures.
  • Secure the licence early. Engage the provincial/municipal health commission on the 医疗机构执业许可证 pathway and timeline before committing capital.
  • Choose the city deliberately. Weight the nine pilot regions by expatriate demand, existing foreign-medical-institution experience, and real-estate/payer access; TOD health-city models (as Pengruili deployed) can de-risk fixed costs.
  • Model the exclusions. Confirm the project is neither TCM nor a public-hospital acquisition, and build HGR and data-export compliance into the design from day one.
  • Watch the 2026 expansion. Track the action plan’s further pilot-region enlargement — new eligible cities may open greenfield options without a JV.
  • Plan the JV alternative. Where speed or a local partner matters, the nationwide JV route remains available and battle-tested.

Common pitfalls

  • Assuming WFOE is allowed nationwide. It is confined to the nine pilot regions; elsewhere a JV is required.
  • Assuming TCM or public-hospital M&A is permitted. Both are explicitly excluded from the pilot.
  • Overlooking HGR and data-export rules. International groups running research or centralising data can breach HGR/PIPL without a compliant design.
  • Underestimating licensing and staffing lead times. The 执业许可证 and physician-qualification pathway are the critical path, not the capital.
  • Treating the pilot as settled national policy. It remains a pilot whose geography and conditions can expand or adjust — plan for change.

Sources

  • 国务院新闻办发布会介绍利用外资固稳促优有关政策措施 (2026-06): https://www.gov.cn/lianbo/fabu/202606/content_7074496.htm
  • 人民日报（海外版）《独资医院领域扩大开放试点工作方案》解读 (2024-12-03): https://paper.people.com.cn/rmrbhwb/pc/content/202412/03/content_30032517.html
  • 光明日报《我国首家外商独资三级综合医院开诊》(2025-02-27): https://m.gmw.cn/gmsogh/202502/27/37873333.html
  • 商务部（MOFCOM）官方门户：https://www.mofcom.gov.cn

Related reading

  • see also: Healthcare & pharma market access (NMPA) / 医疗医药准入（药监局）
  • see also: Pharma opening measures under the 2026 action plan / 医药产业开放新措施

2026 外资办医政策松绑与落地城市

概述

医疗服务是中国少数外资准入仍属有条件开放的服务大类中之一，但 2024–2026 年迎来了 Generation 以来最显著的开放。核心是一项和以往不同、首次允许在九个指定区域设立外商独资医院的试点，同时全国仍可走的合资路线依旧有效。2026 年《利用外资固稳促优行动方案》进而承诺进一步扩大试点。

本文梳理开放时间线、九个试点区域及其选定逻辑、已落地的案例、合资基线，以及外资投资者须规划的实务约束与步骤。本文仅为信息参考，不构成监管或法律意见。

开放时间线（2024–2026）

  • 2024 年 9 月——三部委会医疗试点通知。 商务部、国家卫健委、国家药监局印发在医疗领域开展扩大开放试点的通知。生物技术领域，允许外商投资企业在北京、上海、广东自由贸易试验区与海南自由贸易港，从事人体干细胞、基因诊断与治疗技术开发和应用，用于产品注册上市和生产。医院领域，拟允许在北京、天津、上海、南京、苏州、福州、广州、深圳、海南全岛设立外商独资医院（中医类除外，不含并购公立医院）。
  • 2024 年 11 月 1 日——负面清单清空制造业。 2024 年版负面清单施行，清除制造业领域最后的外资准入限制。医院虽属服务业，但此举表明整体开放方向，并便利了外资医疗投资者的配套制造（如器械、耗材）。
  • 2024 年 11 月——独资医院试点方案。 国家卫健委、商务部、国家中医药局、国家疾控局公布《独资医院领域扩大开放试点工作方案》，固化九区域试点与除外情形。
  • 2026 年 1 月——九城市服务业扩大开放试点。 商务部印发大连等 9 城市服务业扩大开放综合试点任务，部署 159 项（103 项共性加 3 项新增），覆盖医疗康养开放、电信、金融等，将政策底盘大幅扩展至九个医院试点区域之外。
  • 2026 年 6 月——行动方案扩围信号。 国务院新闻办在《利用外资固稳促优行动方案》发布会上确认：生物技术试点覆盖北京、上海、广东 3 个自贸区加海南，外商独资医院试点覆盖九地；并承诺在评估初期落地后，抓紧研究进一步扩大上述领域试点地域范围。

九个试点区域及其逻辑

九地为北京、天津、上海、南京、苏州、福州、广州、深圳与海南全岛。国家卫健委给出的理由务实。其一，需求：这些地区开放度高、外资企业与外籍人员密集，多元化医疗需求更强。其二，治理成熟度：自 2000 年《中外合资、合作医疗机构管理暂行办法》以来，相当比例的中外医疗机构正聚集于这九省市，积累了监管经验。其三，投资权重：这些区域实际使用外资总额占比超 45%，天然是医院投资磁石。

已落地案例

  • 天津鹏瑞利医院——旗舰。 2024 年 12 月 16 日天津颁发首张外商独资三级综合医院执业许可证；医院于 2025 年 2 月 26 日开诊。由新加坡鹏瑞利集团投资约 10 亿元、设 500 张床位，提供多专科及面向定制与慢病管理的国际部，坐落于天津南站健康城 TOD 综合体。
  • 广州——康复与三级综合布局。 广州开发区与鹏瑞利合作建设全市首家外商独资专科医院（康复医院），预计 2026 年底运营；白云区另有一期投资 10 亿元的项目，规划为华南首家外商独资三级综合医院。
  • 海南——卡位封关。 2025 年底海南自由贸易港封关当日，鹏瑞利投资的外商独资康复医院同步落户。
  • 存量规模。 截至 2025 年底，一批外商独资医院已获批，叠加中国已有的 60 余家外资（多为合资）医疗机构。

合资基线（仍全国可用）

外商独资医院是限于九区域的试点特权。在其之外，外资办医仍依 2000 年《暂行办法》以中外合资或合作医疗机构形式，经省级/市级卫健部门批准设立。这条合资路线仍是想在中国落子、但位于试点区域之外，或偏好本地伙伴以处理土地、人员与支付关系的集团的主力选择。现有的 60 余家外资医疗机构多为合资，提供了成熟模板：外资加中国伙伴共同应对许可、人员与医院管理规则。

外资投资者须遵守的实务约束

开放真实但有边界。关键护栏：

  • 不含中医类。 外商独资医院不得为中医类机构。
  • 不含并购公立医院。 试点明确禁止并购或合并公立医院。
  • 人类遗传资源。 涉及人类遗传资源的研究仍须 HGR 审批与合规——对开展试验或生物样本库的国际化集团是实约束。
  • 数据出境与网络安全。 患者或研究数据的跨境传输须满足《个人信息保护法》及网络安全/重要数据规则；拥有区域或全球数据湖的集团需合规架构。
  • 许可与人员。 须取得卫健部门颁发的《医疗机构执业许可证》；境外 trained 医师须满足中国执业资格要求。

外资投资者下一步

  • 按地域选结构。 独资路线仅限九个试点区域内使用；区域外须按 2000 年办法走合资。
  • 尽早取证。 在投入资本前，就《医疗机构执业许可证》路径与时间表对接省级/市级卫健部门。
  • 审慎择城。 在九试点区域中按外籍需求、既有外资医疗经验、地产与支付可及性加权；TOD 健康城模式（如鹏瑞利）可摊薄固定成本。
  • 建模除外项。 确认项目既非中医类也非公立医院并购，并将 HGR 与数据出境合规从第一天纳入设计。
  • 跟踪 2026 年扩围。 关注行动方案进一步扩大的试点区域——新合格城市可能无需合资即开放绿地选项。
  • 规划合资备选。 当速度或本地伙伴重要时，全国可用的合资路线仍稳健可靠。

常见误读

  • 以为独资全国放开。 其限于九个试点区域；区域外须为合资。
  • 以为中医类或并购公立医院可行。 两者均被试点明确排除。
  • 忽视 HGR 与数据出境规��。 开展研究或集中数据的国际集团，若无合规设计易触 HGR/PIPL 红线。
  • 低估许可与人员周期。 执业许可证与医师资格路径才是关键路径，而非资本。
  • 把试点当既定国策。 其仍是试点，地域与条件可能扩围或调整——须为变化留预案。

来源

  • 国务院新闻办发布会介绍利用外资固稳促优有关政策措施（2026-06）：https://www.gov.cn/lianbo/fabu/202606/content_7074496.htm
  • 人民日报（海外版）《独资医院领域扩大开放试点工作方案》解读（2024-12-03）：https://paper.people.com.cn/rmrbhwb/pc/content/202412/03/content_30032517.html
  • 光明日报《我国首家外商独资三级综合医院开诊》（2025-02-27）：https://m.gmw.cn/gmsogh/202502/27/37873333.html
  • 商务部（MOFCOM）官方门户：https://www.mofcom.gov.cn

相关阅读

  • 参见：医疗医药准入（药监局） / Healthcare & pharma market access (NMPA)
  • 参见：医药产业开放新措施 / Pharma opening measures under the 2026 action plan
Healthcare & Pharma / 医药医疗

Medical-device import registration and the foreign-device strategy under domestic substitution (2026)

  • Imported medical devices still require NMPA registration by risk class (I/II/III), and Class II/III overseas manufacturers must register their production sites with the NMPA before any China market entry.
    进口医疗器械仍须按风险分类（一/二/三类）取得国家药监局注册；二类、三类境外生产企业须向 NMPA 登记生产场地后方可进入中国。
  • Volume-Based Procurement has expanded from high-value implants into routine consumables: the coronary-stent renewal tender opened in Tianjin on 20 May 2026 with every bidder winning, and a 29-province electrosurgical-knife alliance VBP went live on 1 July 2026.
    集中带量采购已从高值植入物扩展到常规耗材：冠脉支架第二轮接续采购 2026 年 5 月 20 日在天津开标、投标企业全部中选；覆盖 29 省的电刀省际联盟集采于 2026 年 7 月 1 日落地。
  • Domestic substitution is measurably eroding foreign share — foreign penetration in some consumable segments fell from about 45% (2020) to under 25% (2025), and peripheral-vessel balloon localisation rose from 28% (2019) to roughly 58% (2025).
    国产替代正在实质侵蚀外资份额——部分耗材外资占比从约 45%（2020）降至 2025 年不足 25%，外周血管球囊国产化率从 28%（2019）升至 2025 年约 58%。
  • Foreign device makers are answering with in-China production: ERBE’s first locally built high-frequency surgical unit (VIO S CN) received its NMPA certificate on 11 June 2026 and rolled off the line on 1 July 2026.
    外资器械企业以”在华生产”应对：爱尔博首台国产高频手术设备 VIO S CN 于 2026 年 6 月 11 日获 NMPA 注册证，7 月 1 日下线。
  • VBP rules are shifting from “lowest-price-wins” toward value-based evaluation, rewarding firms with genuine technology, scale and supply stability rather than pure cost.
    集采规则正从”唯低价”转向综合价值评价，利好具备真实技术、规模与供应稳定性的企业。
  • The practical foreign-device strategy is to register imports to hold premium segments, localise production to defend volume segments under VBP, and engage the province alliances early.
    务实的外资器械策略是：以进口注册守住高端细分，以本地化生产捍卫集采下的走量细分，并尽早介入省际联盟。

Medical-device import registration and the foreign-device strategy under domestic substitution (2026) | 2026 医疗器械进口注册与国产替代下外资器械企业策略

Overview

Medical devices sit at the intersection of tight registration control and aggressive procurement reform. For a foreign device company, market access is a two-stage problem: first clear the NMPA registration gateway (still mandatory and class-based), then survive the commercial gateway of Volume-Based Procurement, where domestic substitution has become the explicit policy direction. 2026 is a pivotal year because VBP has pushed from headline implants — stents, joints — into everyday consumables, and because the 2024 negative-list “clearing” of manufacturing restrictions makes in-China production by a wholly foreign-owned plant straightforward for the first time.

This article explains the import-registration gateway, the 2026 VBP and substitution landscape, why localisation has become the default foreign response, and the practical moves a foreign device group should plan. It is informational guidance, not regulatory or legal advice.

The import-registration gateway

Registration is risk-tiered. Devices are classified Class I (low), Class II (medium) and Class III (high). Class I devices are filed with the provincial NMPA office; Class II and III require registration with the NMPA (via the Centre for Medical Device Evaluation, CMDE). A registration dossier needs product technical requirements, type testing at an accredited laboratory, and a clinical evaluation or trial unless the device falls under an exemption catalogue. Quality-system compliance (Good Manufacturing Practice for medical devices) is inspected, and — critically for importers — overseas manufacturers of Class II/III devices must register their production site with the NMPA.

A frequent blind spot is the clinical-evaluation route. Not every Class II/III device needs a trial: where a product is comparable to an already-marketed same-species device, a literature-and-data “same-species” comparison can support trial exemption; novel or high-risk devices with no predicate still require a trial. The route choice dictates evidence cost and launch pace and should be settled at project kick-off. Imported products also need Chinese labels and package inserts; customs clearance hinges on the NMPA registration certificate as a key document.

The 2026 VBP and substitution landscape

VBP — the “集中带量采购” program that exchanges steep price cuts for committed volume — has become the dominant commercial gate for devices, and 2026 shows it reaching deeper into consumables.

Coronary stents, renewal round. On 20 May 2026 the national organisation opened the second renewal tender for coronary stents in Tianjin. Fifteen enterprises with 30 products bid, all bidders won, and 27 products were pre-selected — including upgraded new products from both foreign players (Medtronic’s “Resolute Onyx”, Abbott, Boston Scientific) and domestic leaders (MicroPort, Lepu, JW). Demand came from 4,468 medical institutions (up 86% vs the first tender) with an annual requirement of about 2.73 million stents (up 155%). Stainless-steel stents were included in the national tender for the first time at a ceiling of ¥848, while the alloy-stent ceiling was raised about 11.9% to ¥949 — a signal that rules are moderating toward value rather than pure price.

Electrosurgical knives, 29-province alliance. A Hunan-led inter-provincial alliance covering 29 provinces, municipalities and the Xinjiang Production and Construction Corps went live on 1 July 2026, with a two-year purchasing cycle and total volume above 20 million units/pieces and a market scale above ¥3.5 billion. In 17 core bidding groups, domestic brands took the lowest bid in 16 — and analysts estimate foreign share of the electrosurgical consumable market (above 50% before the tender) could fall below 30% afterward.

Broader alliance activity. The “3+N” and provincial alliances kept broadening through 2026: dural patches and indwelling needles (Tianjin-led, results published 11 March 2026), digestive-intervention snares, peripheral-vessel balloons and orthopaedic irrigation systems (Hebei-led product briefings in March 2026), plus起搏器 and peripheral micro-catheters spanning 27–29 provinces. The clear trend: VBP is becoming the normal commercial environment across the device catalogue.

Measurable substitution. The effect on foreign share is concrete. In digestive-intervention snares, foreign brands’ share fell from about 45% (2020) to under 25% (2025) as domestic players like Micro-Tech pushed hospital penetration above 70%. In peripheral-vessel constrained balloons — long monopolised by Medtronic and Abbott — localisation rose from 28% (2019) to about 58% (2025) and is expected to exceed 70% after the latest tender, with domestic leaders Lepu, Volcano (Huatai) and HeartCare (MicroPort) capturing share. Foreign brands retain an edge only in complex, high-end niches where price gaps of 3–5× still apply but where VBP’s volume logic steadily erodes the addressable market.

Why localisation is now the default response

Faced with VBP price compression and substitution pressure, an increasing number of foreign device makers are shifting from “import the finished unit” to “build it in China.” The logic is operational as much as commercial.

ERBE’s VIO S CN is the 2026 template. ERBE, the German electrosurgery leader (market share ~43.9% of high-frequency surgical-equipment tenders in Jan–May 2026), had imported its units from Germany, absorbing long shipping and customs lead times and high distribution cost. Its first China-built host, VIO S CN — developed with deep Chinese-team input on the German production system — received its NMPA registration certificate on 11 June 2026 and rolled off the line on 1 July 2026. Local production compresses logistics and import cost and sharply improves supply responsiveness, exactly the variables VBP punishes importers on.

Manufacturing is now open. The 2024 negative list cleared all manufacturing-sector foreign-access restrictions (effective 1 November 2024), so a wholly foreign-owned device manufacturing plant in China no longer faces the sector caps that once applied. Combined with theNMPA production-site registration for Class II/III, a foreign maker can stand up a China plant, register the site, and obtain domestic NMPA certificates for locally made SKUs — converting an “import” into a “domestic product” for tender purposes.

The rules now reward local players’ strengths. VBP design is moving from pure price toward comprehensive value evaluation — technical briefing, clinical argument, cost verification — which preserves reasonable margin for firms with real technology and scale. Local production is the most direct way for a foreign maker to match domestic competitors on price, lead time and supply stability while keeping original-equipment quality.

2026 policy context

  • Innovation prioritisation. The Medical Device Supervision and Administration Regulation directs that innovative devices receive priority review and approval, supporting domestic and foreign innovators alike in bringing novel products to market.
  • Manufacturing fully open. The 2024 negative list’s removal of the last manufacturing restrictions means device manufacturing welcomes wholly foreign-owned investment nationwide.
  • Opening under the 2026 action plan. The “Stabilising and Improving Foreign Investment” action plan (effective 1 July 2026) reinforces a pro-foreign-investment stance across healthcare and supports measures such as drug segmented manufacturing and expanded biotech/hospital pilots — the broader policy backdrop foreign device groups operate within.

What foreign device groups should do next

  • Map the portfolio against VBP exposure. Classify each SKU by whether it sits in a tendered category, its substitution risk, and whether it is premium/non-substitutable or volume/price-sensitive.
  • Keep importing where defensible. For high-end, clinically differentiated devices with weak domestic predicates, hold the import-registration route and protect premium positioning.
  • Localise where volume is at stake. For tendered, price-sensitive lines, stand up or contract China manufacturing, register the site with the NMPA, and obtain domestic certificates to compete on VBP terms.
  • Settle the clinical-evaluation route early. Decide same-species comparison, exemption or full trial at kick-off to fix evidence cost and timeline.
  • Engage the alliances proactively. Track province-alliance pipelines (Hebei, Tianjin “3+N”, Hunan, Guangdong, Zhejiang) and prepare technical briefings that support value-based evaluation.
  • Prepare Chinese labelling, inserts and a traceability system before launch, and treat the NMPA registration certificate as the customs-critical document.

Common pitfalls

  • Assuming registration equals access. Clearing NMPA registration is necessary but not sufficient; VBP outcome, not the certificate, often decides volume.
  • Importing into a tendered category. Finished-unit imports cannot match localised competitors on VBP price and lead time and will lose share.
  • Ignoring the production-site registration. Class II/III overseas manufacturers must register their site with the NMPA — a step easily missed when planning local production.
  • Treating VBP as pure price. Rules now weight technology and supply stability; a weak value story loses even when price is competitive.
  • Late alliance engagement. By the time a tender opens, grouping and evaluation are largely set; influencing them requires early technical briefing.

Sources

  • National Medical Products Administration (NMPA) — official portal: https://www.nmpa.gov.cn
  • 国家医疗保障局（NHSA）——集中带量采购：https://www.nhsa.gov.cn/
  • 国务院新闻办发布会介绍利用外资固稳促优政策措施 (2026-06): https://www.gov.cn/lianbo/fabu/202606/content_7074496.htm
  • 国务院《利用外资固稳促优行动方案》(2026-06): https://www.gov.cn/zhengce/zhengceku/202606/content_7072838.htm

Related reading

  • see also: Healthcare & pharma market access (NMPA) / 医疗医药准入（药监局）
  • see also: Pharma opening measures under the 2026 action plan / 医药产业开放新措施

2026 医疗器械进口注册与国产替代下外资器械企业策略

概述

医疗器械处在严格注册控制与激进采购改革的十字路口。对外资器械企业而言，市场准入是两段式问题：先越过国家药监局的注册关口（仍属强制且按类管理），再穿越集中带量采购这一商业关口——而国产替代已是明确的政策方向。2026 年是关键之年：集采从支架、关节等标志性植入物，推进到日常耗材；同时 2024 年版负面清单”清零”制造业准入限制，使外商独资器械工厂在华设厂首次变得顺理成章。

本文说明进口注册关口、2026 年集采与替代格局、为何本土化已成为外资的默认应对，以及外资器械集团应规划的务实举措。本文仅为信息参考，不构成监管或法律意见。

进口注册关口

注册按风险分类管理。器械分为第一类（低）、第二类（中）、第三类（高）。第一类向省级药监部门备案；第二类、第三类须向国家药监局（经医疗器械技术审评中心 CMDE）注册。注册资料需产品技术要求、资质实验室型检，以及临床评价或临床试验（除非属豁免目录）。质量体系（《医疗器械生产质量管理规范》）须受检，且——对进口商关键的是——二类、三类境外生产企业须向国家药监局登记其生产场地。

常见盲点是临床评价路径。并非所有二类、三类器械都需临床试验：若产品与已上市同品种器械可比，可通过文献与数据的”同品种”比对支持免于临床；无同品种可比或高风险的创新器械仍须开展临床试验。该路径选择决定证据成本与上市节奏，应在立项时即敲定。进口产品还须配中文标签与说明书；清关以国家药监局注册证为关键单证。

2026 年集采与替代格局

集中带量采购（”集采”以大幅降价换取约定采购量）已成为器械主导性商业关口，而 2026 年显示其正深入日常耗材。

冠脉支架，接续轮。 2026 年 5 月 20 日，国家组织在天津开标冠脉支架第二轮接续采购。15 家企业、30 个产品投标，投标企业全部中选，27 个产品获拟中选资格——既含外资新品（美敦力”Resolute Onyx”、雅培、波士顿科学），也含国内龙头（微创、乐普、吉威）。填报需求来自 4468 家医疗机构（较首轮增 86%），年度需求量约 273 万个（增 155%）。不锈钢支架首次纳入国家集采，最高有效申报价 848 元；合金支架上限由 848 元上调约 11.9% 至 949 元——信号是规则正从唯价向价值适度回调。

电刀，29 省联盟。 湖南牵头的省际联盟覆盖 29 个省区市及新疆生产建设兵团，于 2026 年 7 月 1 日落地，采购周期两年，总需求量超 2000 万把/片，市场规模超 35 亿元。17 个核心竞价组中，国产品牌包揽 16 组最低报价；分析估计外资电外科耗材份额（集采前超 50%）此后或降至 30% 以下。

更广的联盟活动。 “3+N”与省级联盟在 2026 年持续扩围：硬脑（脊）膜补片与留置针（天津牵头，3 月 11 日公布结果）、消化介入圈套器、外周血管约束型球囊与骨科冲洗系统（河北 3 月产品介绍）、以及覆盖 27–29 省的起搏器与外周微导管。清晰趋势：集采正成为器械目录的常态化商业环境。

可量化的替代。 对外资份额的影响很具体。消化介入圈套器领域，外资占比从约 45%（2020）降至 2025 年不足 25%，南微医学等国产将二级以上医院渗透率推过 70%。外周血管约束型球囊——长期由美敦力、雅培垄断——国产化率从 28%（2019）升至 2025 年约 58%，最新集采后有望破 70%，国产龙头乐普、惠泰、心脉抢占份额。外资仅在复杂高端细分仍具优势，但集采的量价逻辑持续压缩其可及市场。

为何本土化成为默认应对

面对集采降价与替代压力，越来越多外资器械企业正从”进口整机”转向”在华制造”。其逻辑既是商业也是运营。

爱尔博 VIO S CN 是 2026 年范本。 德国电外科龙头爱尔博（2026 年 1–5 月高频手术设备中标市占约 43.9%）此前整机自德国进口，承受漫长海运、跨境报关的高流通成本与长供货周期。其首台国产主机 VIO S CN——由中国团队深度参与、依托德国原装生产体系——于 2026 年 6 月 11 日获国家药监局注册证，7 月 1 日下线。本地生产压缩物流与进口成本，并显著提升供货响应，而这正是集采惩罚进口商的变量。

制造业现已放开。 2024 年版负面清单清空了制造业领域外资准入限制（2024 年 11 月 1 日施行），外商独资器械制造厂在华不再面临此前的行业上限。结合二类、三类器械的 NMPA 生产场地登记，外资可在中国建厂、登记场地，并为本地生产单品取得国产注册证——将”进口”转为集采意义上的”国产”。

规则现在奖励本地玩家的强项。 集采设计正从纯价格转向综合价值评价——技术介绍、临床论证、成本核验——为具备真实技术与规模的企业保留合理利润。本地生产是外资在价格、交期与供应稳定性上对标国产、同时保留原厂品质的最直接方式。

2026 年政策语境

  • 创新优先。 《医疗器械监督管理条例》明确支持创新医疗器械优先审评审批，惠及本土与外资创新者将新产品推向市场。
  • 制造业全面放开。 2024 年负面清单清除最后制造业限制，意味着器械制造在全国欢迎外商独资投资。
  • 行动方案下的开放。 《利用外资固稳促优行动方案》（2026 年 7 月 1 日落地）重申亲外资立场，并支持药品分段生产、扩大生物技术与人独资医院试点等举措——这是外资器械企业所处的更宽政策背景。

外资器械集团下一步

  • 按集采敞口映射产品组合。 将每个单品归类至是否属集采品类、替代风险高低、以及是溢价不可替还是走量价格敏感。
  • 在可守处继续进口。 对临床差异化强、国产无同品种可比的高端器械，守住进口注册路线并保护溢价定位。
  • 在走量处本土化。 对集采、价格敏感产线，自建或合同制造，向国家药监局登记场地并取得国产证，以集采条款竞争。
  • 尽早敲定临床评价路径。 立项即决定同品种比对、免于临床或临床试验，以固定证据成本与时间表。
  • 主动介入联盟。 跟踪河北、天津”3+N”、湖南、广东、浙江等省际联盟动向，准备支撑价值评价的技术介绍。
  • 上市前备好中文标签、说明书与可追溯体系，并将国家药监局注册证视为清关关键单证。

常见误读

  • 以为注册即准入。 越过国家药监局注册是必要非充分；决定销量的常是集采结果而非证书。
  • 把整机进口进集采品类。 进口整机在集采价格与交期上无法对标本土化对手，必失份额。
  • 忽视生产场地登记。 二类、三类境外生产企业须向国家药监局登记场地——规划本地生产时极易遗漏。
  • 把集采当纯价格。 规则现已权衡技术与供应稳定性；价值陈述薄弱者即便价格有竞争力也会落败。
  • 联盟介入太晚。 集采开标时分组与评价基本已定；影响它们需提前技术介绍。

来源

  • 国家药品监督管理局（NMPA）——官方门户：https://www.nmpa.gov.cn
  • 国家医疗保障局（NHSA）——集中带量采购：https://www.nhsa.gov.cn/
  • 国务院新闻办发布会介绍利用外资固稳促优政策措施（2026-06）：https://www.gov.cn/lianbo/fabu/202606/content_7074496.htm
  • 国务院《利用外资固稳促优行动方案》（2026-06）：https://www.gov.cn/zhengce/zhengceku/202606/content_7072838.htm

相关阅读

  • 参见：医疗医药准入（药监局） / Healthcare & pharma market access (NMPA)
  • 参见：医药产业开放新措施 / Pharma opening measures under the 2026 action plan
Healthcare & Pharma / 医药医疗

China’s innovative-drug market and the foreign-pharma China playbook (2026)

  • China’s innovative-drug market is projected to exceed ¥1.3 trillion in 2026, with 2025 out-licensing deals reaching roughly US$135 billion and the first quarter of 2026 alone surpassing US$60 billion.
    2026 年中国创新药市场规模预计突破 1.3 万亿元；2025 年对外授权交易总额约 1357 亿美元，2026 年一季度即突破 600 亿美元。
  • The 2026 Government Work Report named biopharmaceuticals an “emerging pillar industry” for the first time, and a revised drug-administration regulation effective 15 May 2026 introduces six-year data protection and seven-year rare-disease exclusivity.
    2026 年政府工作报告首次将生物医药列为”新兴支柱产业”；2026 年 5 月 15 日施行的药品管理新规引入 6 年数据保护与 7 年罕见病市场独占。
  • Foreign pharma’s China role has shifted from “sell-in” to “license-in and co-develop”: multinationals now source early-stage assets from Chinese biotechs at an estimated 30%–40% of US development cost.
    外资药企在华角色已从”卖药”转向”引进与共创”：跨国药企以约为美国 30%–40% 的成本从中国 Biotech 采购早期管线。
  • AstraZeneca, Novartis, Roche, Sanofi and Lilly have announced deep localisation commitments — AstraZeneca alone plans over ¥100 billion by 2030 in China R&D and manufacturing.
    阿斯利康、诺华、罗氏、赛诺菲、礼来等已宣布深度本土化承诺——仅阿斯利康便计划 2030 年前在华投入超 1000 亿元用于研发与制造。
  • NMPA’s ICH alignment and priority-review pathways let China-discovered assets reach global markets faster, recasting China as an innovation “source” rather than only a “market.”
    国家药监局与 ICH 接轨及优先审评通道，使中国发现的资产更快走向全球，将中国从单纯的”市场”重塑为创新”源头”。
  • Practical entry levers for foreign players are license-in partnerships, local R&D centres, in-China manufacturing, and active NRDL/VBP engagement — not import-only models.
    外资企业的务实抓手是授权引进合作、本土研发中心、在华生产，以及主动参与医保目录/集采，而非单纯进口模式。

China’s innovative-drug market and the foreign-pharma China playbook (2026) | 2026 中国创新药市场与外资药企的中国策略

Overview

China’s innovative-drug sector has moved from “imitation-driven” to “innovation-exporting” in a matter of years, and 2026 is the year that shift became structural. The macroeconomic framing is unusually explicit: the 2026 Government Work Report named biopharmaceuticals an “emerging pillar industry” for the first time, placing the sector alongside integrated circuits, aerospace and the low-altitude economy. For foreign-invested pharmaceutical companies, the implication is that China is no longer just a sales territory to be supplied from overseas plants — it is now a discovery and development engine that multinationals are increasingly woven into.

This article maps the 2026 market size and deal landscape, explains why foreign pharma is “going Chinese” through license-in and co-development, details the localisation playbook foreign groups are deploying, and sets out practical entry levers. It is informational guidance, not regulatory or legal advice; confirm current rules with the NMPA and qualified PRC counsel.

Market context: scale, output and the BD boom

The market is large and still expanding. Industry estimates put China’s innovative-drug market at about ¥1.13 trillion in 2024, roughly ¥1.22 trillion in 2025, and a projected ¥1.3 trillion-plus in 2026. The growth story is less about volume than about structure: domestic innovative assets now dominate new approvals. The NMPA approved 76 innovative drugs in 2025 — up about 58% year-on-year, with domestically developed products accounting for more than 80% of the total. By mid-April 2026 the regulator had already cleared 13 innovative drugs for the year, including six first-in-class medicines, and by the end of the first quarter it had approved 10, eight of them domestic.

The pipeline is globally significant. At the end of 2025 China had 4,751 drugs in active research, about 33.7% of the global total — making it the largest single-country pipeline in the world. In next-generation modalities the lead is sharper still: as of late 2025 China contributed roughly 34% of early-stage next-generation-therapy pipelines globally, and led in antibody-drug conjugates (ADCs, ~54% share) and bispecific/multispecific antibodies (~48% share).

The defining commercial event of 2025–2026 is the outbound-licensing (BD) surge. Chinese drugmakers signed more than 150 out-licensing agreements in 2025 with total deal value above US$135 billion — the first time China surpassed the United States as the top source of such deals globally. The momentum accelerated into 2026: NMPA preliminary statistics show out-licensing deal value exceeded US$60 billion in the first three months of 2026, already nearly half of the prior full year’s total, and one industry tracker put Q1 2026 cross-border out-licensing at about US$61.4 billion, roughly 70% of global deal value that quarter. Deal structure is also evolving from single-asset licensing toward broader platform partnerships and NewCo structures that retain long-term upside for the Chinese originator.

Why foreign pharma is “going Chinese”

For most of the 2010s, a multinational’s China operation meant importing finished products and running local sales. That model is being replaced by deep integration into China’s discovery ecosystem. Three forces drive the change.

Cost-and-quality arbitrage. Bankers close to the market note that, for early-stage innovative assets, multinational “China sourcing” can cost an estimated 30%–40% of the equivalent US development cost while matching or beating efficacy — a combination that makes China a core pipeline source rather than a peripheral one. A senior JPMorgan healthcare banker has cited a multinational CFO’s view that, where the same pipeline can be sourced in China at a fraction of US cost with potentially superior outcomes, the choice is obvious.

A maturing, globally credible asset base. China’s regulatory system has converged with international standards: by the end of 2025 the NMPA had issued 71 ICH implementation announcements covering the full arc from early research to manufacturing quality control. Clinical-trial data generated in China under ICH-GCP now have a credible pathway to acceptance by the US FDA and EU EMA for global filings. China registered 5,173 drug trials in 2025, up nearly 99% from 2,602 in 2020, and patient recruitment cycles run shorter than the global average — a real operating-efficiency advantage for global programs.

Confidence expressed in cash. The headline license deals of 2025–2026 read like a roll-call of China-to-world transactions: CSPC signed a multi-project peptide partnership with AstraZeneca in January 2026; Sino Biopharm out-licensed a JAK/ROCK inhibitor to Sanofi for US$1.53 billion; Innovent extended its long-running Lilly alliance with a deal carrying US$350 million upfront and up to ~US$8.5 billion in milestones; and 3SBio’s PD-1/VEGF bispecific drew a record US$1.25 billion upfront from Pfizer. These are not one-off asset sales — they signal a structural re-rating of Chinese innovation as a global supply source.

The localisation playbook foreign groups are deploying

Foreign pharma is backing this strategic shift with capital and bricks. The pattern has moved from “light-asset sales offices” to “heavy-asset rooted platforms.”

R&D centres with real decision rights. AstraZeneca opened its sixth global strategic R&D centre in Beijing in October 2025 (a US$2.5 billion investment) and runs a parallel Shanghai engine; it plans to exceed ¥100 billion (about US$15 billion) of cumulative China R&D and manufacturing investment by 2030, including cell-therapy and radioligand-therapy bases in Shanghai and Guangzhou. Roche’s Shanghai innovation centre holds independent new-drug decision authority, with more than ten locally discovered molecules advanced to clinic, and its China Accelerator (launched 2021) had brought nearly 20 domestic biotech startups into its orbit by end-2024. Novartis operates three China R&D sites (Shanghai, Beijing, Suzhou) and, since 2024, has struck potential cooperation worth over ¥80 billion with Chinese innovators across cardiovascular, oncology, renal and neuroscience. Pfizer’s Beijing R&D centre, its third in China, anchors a “China-All-In” strategy embedding China in global early and pivotal Phase III programs.

Manufacturing upgraded to high-value categories. Sanofi broke ground on a Beijing insulin active-pharmaceutical-ingredient project (€1 billion) in October 2025 and opened a Chengdu innovation-and-operations centre in March 2026 (12,600 m², ~600 jobs). Lilly plans US$3 billion of China investment over the decade, including a US$200 million Suzhou expansion and Beijing/Shanghai incubators. Roche is building a Zhangjiang biopharma base (¥2.04 billion) and a Suzhou diagnostics plant (its largest single China investment). Novo Nordisk’s Tianjin site has drawn cumulative investment above ¥10 billion, with a further ¥4 billion quality-lab expansion completing in 2026.

Ecosystem co-creation over wholly-owned control. The dominant new mode is “capital + technology + ecosystem”: J&J’s JLABS Shanghai is among its largest global incubators; Bayer’s Zhangjiang co-creation platform targets small molecules, nucleic-acid drugs and AI drug discovery; AstraZeneca and CICC run a healthcare fund; and NewCo structures let Chinese originators retain upside while importing global capital and management. The logic, in one executive’s phrasing, is to “monetise current value while embedding into the global innovation network.”

2026 policy tailwinds

Beyond market pull, the policy environment in 2026 actively supports foreign participation.

  • Emerging-pillar status. The 2026 Government Work Report’s explicit naming of biopharmaceuticals as a pillar industry signals sustained, cross-ministry support rather than a one-off stimulant.
  • Stronger IP and exclusivity. A revised regulation implementing the Drug Administration Law took effect on 15 May 2026, introducing six-year regulatory data protection, seven-year market exclusivity for rare-disease drugs, and additional incentives for paediatric medicines — measures analysts say improve China’s attractiveness for global development partnerships.
  • Faster access. New-drug clinical-trial review timelines have been compressed from 60 to 30 working days, and time from approval to NRDL inclusion has shortened to about one year, narrowing the commercialisation gap that previously discouraged multinationals from launching novel assets in China first.
  • Openness under the 2026 action plan. The “Stabilising and Improving Foreign Investment” action plan (effective 1 July 2026) supports drug segmented-manufacturing rules and expands biotech and wholly-foreign-owned-hospital pilot regions — see the companion brief on pharma opening measures — reinforcing the message that foreign players are welcome across the value chain.

What foreign players should do next

  • Reframe China as a source, not just a market. Build or buy access to Chinese discovery assets through license-in, platform partnerships and NewCo structures rather than relying solely on imported products.
  • Plant R&D and manufacturing roots. Where the portfolio justifies it, establish or expand in-China R&D centres with local decision rights and high-value local manufacturing — this is now the expectation, not the exception.
  • Engage the NRDL/VBP reality early. Reimbursement and volume-based procurement determine commercial viability for most drugs; model them as part of the entry case, not as downstream marketing.
  • Leverage the regulatory convergence. Use ICH-aligned, China-generated data for global filings and consider China for simultaneous global trials to exploit speed and recruitment efficiency.
  • Protect the downside. Pair deeper integration with robust IP, data-protection and compliance posture, given the higher capital commitment localisation entails.

Common pitfalls

  • Treating China as a sales outpost. Groups that import only will miss the cost and speed advantages of Chinese discovery and risk being out-competed by locals and by peers who localised earlier.
  • Assuming overseas approval substitutes for China registration. An FDA/EMA licence does not register a product in China; a separate NMPA pathway with Chinese data is still required.
  • Under-resourcing local decision rights. Centres without real pipeline authority become expensive liaison offices; the winners grant China teams genuine development mandates.
  • Ignoring reimbursement until launch. NRDL and VBP outcomes — not the registration grant — often decide commercial success.
  • Over-concentrating in one modality. China’s strength is broad (ADC, bispecifics, GLP-1, cell therapy, radioligand), so a single-theme bet underuses the ecosystem.

Sources

  • National Medical Products Administration (NMPA) — official portal: https://www.nmpa.gov.cn
  • NMPA — English portal: https://english.nmpa.gov.cn
  • 国务院《利用外资固稳促优行动方案》(2026-06, 商资发〔2026〕97号): https://www.gov.cn/zhengce/zhengceku/202606/content_7072838.htm
  • 国务院新闻办发布会介绍利用外资固稳促优政策措施 (2026-06): https://www.gov.cn/lianbo/fabu/202606/content_7074496.htm

Related reading

  • see also: Healthcare & pharma market access (NMPA) / 医疗医药准入（药监局）
  • see also: Pharma opening measures under the 2026 action plan / 医药产业开放新措施

2026 中国创新药市场与外资药企的中国策略

概述

中国创新药产业在数年间完成了从”仿创结合”到”创新输出”的跃迁，而 2026 年正是这一转变固化为结构性的时点。宏观层面的定调尤为罕见：2026 年政府工作报告首次将生物医药列为”新兴支柱产业”，与集成电路、航空航天、低空经济并列。对在华外资药企而言，这意味着中国已不再只是由海外工厂供货的销售疆域，而是跨国药企日益深度嵌入的发现与开发引擎。

本文梳理 2026 年的市场规模与交易格局，解释外资药企为何通过授权引进与共创走向”中国化”，剖析外资集团正在部署的本土化打法，并给出务实的进入抓手。本文仅为信息参考，不构成监管或法律意见；请以国家药监局及合格中国法律顾问确认最新规则。

市场语境：规模、产出与 BD 热潮

市场体量庞大且仍在扩张。行业估算显示，2024 年中国创新药市场规模约 1.13 万亿元，2025 年约 1.22 万亿元，2026 年预计突破 1.3 万亿元。增长故事的关键在于结构而非规模：国产创新资产如今主导新获批品种。国家药监局 2025 年批准 76 款创新药，同比增长约 58%，其中国产占比超过 80%。截至 2026 年 4 月中旬，监管方年内已放行 13 款创新药，含 6 款首创新药；到一季度末已批 10 款，其中 8 款为国产。

研发管线具备全球分量。2025 年底，中国在研创新药达 4751 个，约占全球总量的 33.7%，是全球单一国家中最大的在研管线。在下一代疗法领域领先更明显：截至 2025 年三季度，中国贡献了全球早期下一代疗法管线的约 34%，并在抗体偶联药物（ADC，约 54% 份额）与双抗/三抗（约 48% 份额）领域领跑。

2025–2026 年最具标志性的商业事件是出海授权的爆发。2025 年中国药企签署对外授权协议超 150 笔，总交易额逾 1357 亿美元，首次超越美国成为全球第一来源地。势头在 2026 年加速：国家药监局初步统计显示，2026 年前三个月对外授权交易额突破 600 亿美元，已接近上年全年的半数；有行业跟踪机构测算一季度跨境对外授权约 614 亿美元，约占当季全球交易额的 70%。交易结构也正从单资产授权，演进为更广泛的平台合作与保留长期上行空间的 NewCo 模式。

外资药企为何”中国化”

在 2010 年代的大部分时间里，跨国药企的中国业务意味着进口成品加本地销售。这一模式正被深度融入中国发现生态所取代，背后有三股力量。

成本与质量的套利。 贴近市场的投行人士指出，对早期创新资产而言，跨国药企的”中国采购”成本可低至美国开发成本的 30%–40%，且疗效相当或更优——这一组合使中国从边缘来源变为核心管线来源。某资深摩根大通医疗健康银行家援引一家跨国药企 CFO 的观点：当同一管线能以美国几分之一的成本在华获取且可能疗效更优时，选择不言自明。

成熟且全球可信的资产基础。 中国监管体系已与国际接轨：截至 2025 年底，国家药监局已发布 71 项 ICH 实施公告，覆盖从早期研究到生产质量控制的完整链条。按 ICH-GCP 在中国生成的数据，已具备被美国 FDA、欧洲 EMA 接受并用于全球申报的可行路径。2025 年中国登记药物临床试验 5173 项，较 2020 年的 2602 项增长近 99%，且患者入组周期短于全球平均——这对全球研发项目是真实的运营效率优势。

以资金表达的信心。 2025–2026 年的重磅授权交易堪称中国走向世界的清单：2026 年 1 月石药与阿斯利康签署多肽多项目合作；中国生物制药以 15.3 亿美元将 JAK/ROCK 抑制剂授权给赛诺菲；信达延展与礼来的长期联盟，交易含 3.5 亿美元首付款及最高约 85 亿美元里程碑；三生制药 PD-1/VEGF 双抗更从辉瑞处拿下 12.5 亿美元创纪录首付款。这些不是一次性资产出售，而是对中国创新作为全球供给源的系统性重估。

外资集团正在部署的本土化打法

外资药企正以资本与实体落地为这一战略转向背书。路径已从”轻资产销售办公室”升级为”重资产扎根平台”。

拥有真实决策权的研发中心。 阿斯利康 2025 年 10 月启用北京全球战略研发中心（25 亿美元投资），并与上海引擎并列；计划 2030 年前在华研发与制造累计投入超 1000 亿元，含上海细胞治疗与广州放射偶联药物基地。罗氏上海创新中心拥有独立新药决策权，已有十余款本土发现分子推进至临床；其 2021 年启动的中国加速器截至 2024 年底已引入近 20 家本土 Biotech。诺华在华运营上海、北京、苏州三处研发站点，且自 2024 年以来与本土创新者的潜在合作规模超 800 亿元，覆盖心血管、肿瘤、肾脏与神经科学。辉瑞北京研发中心作为其中国第三家研发中心，承载将中国纳入全球早期与关键三期同步开发的”China-All-In”战略。

向高价值品类升级的制造。 赛诺菲 2025 年 10 月在京启动胰岛素原料药项目（10 亿欧元），并于 2026 年 3 月启用成都创新与运营中心（1.26 万平方米、约 600 个岗位）。礼来计划十年内在华投资 30 亿美元，含 2 亿美元苏州扩建及北京/上海孵化器。罗氏正建设张江生物制药基地（20.4 亿元）与苏州诊断工厂（其在华最大单笔投资）。诺和诺德天津基地累计投资已超百亿元，并追加 40 亿元质量实验室扩建于 2026 年完工。

以生态共创取代全资控制。 主流新模式是”资本+技术+生态”：强生 JLABS 上海是其全球规模最大的孵化器之一；拜耳张江共创平台聚焦小分子、核酸药物与 AI 药物发现；阿斯利康与中金设立医疗健康基金；NewCo 结构让中国原创方保留上行空间，同时引入全球资本与管理。用一位高管的话说，其逻辑是”在兑现当期价值的同时，嵌入全球创新网络”。

2026 年政策顺风

除市场拉力外，2026 年的政策环境主动支持外资参与。

  • 支柱地位。 2026 年政府工作报告明确将生物医药列为支柱产业，意味着跨部委的持续支持，而非一次性刺激。
  • 更强 IP 与独占期。 落实《药品管理法》的修订条例于 2026 年 5 月 15 日施行，引入 6 年数据保护、7 年罕见病市场独占及儿科用药额外激励——分析人士认为这提升了中国对全球开发合作的吸引力。
  • 更快可及。 新药临床试验审评时限已从 60 个工作日压缩至 30 个，从获批到纳入医保目录的时间缩短至约一年，收窄了此前阻碍跨国药企在华首发新品的商业化落差。
  • 行动方案下的开放。 《利用外资固稳促优行动方案》（2026 年 7 月 1 日落地）支持药品分段生产细则并扩大生物技术、外商独资医院试点区域——详见姊妹篇《医药产业开放新措施》——强化外资可全程参与价值链的信号。

外资企业应做的下一步

  • 将中国重构为源头而非仅市场。 通过授权引进、平台合作与 NewCo 结构建立或买断对中国发现资产的触达，而非仅依赖进口产品。
  • 植下研发与制造的树根。 若组合justify，应设立或扩地在华研发中心并赋予本地决策权，并布局高价值本地制造——这已成为预期，而非例外。
  • 早介入医保/集采现实。 报销与带量采购决定多数药品的商业可行性，应作为进入论证的一部分，而非下游营销问题。
  • 借力监管接轨。 用 ICH 接轨、中国生成的数据支撑全球申报，并考虑以中国承接全球同步试验，以利用速度与入组效率。
  • 守住下行。 因本土化意味着更高资本承诺，须配套稳健的 IP、数据保护与合规体系。

常见误读

  • 把中国当销售前哨。 仅做进口的企业将错失中国发现的成本与速度优势，并被本土企业及更早本土化的同行反超。
  • 以为境外批准可替代中国注册。 FDA/EMA 许可不等于在中国注册；仍需走完国家药监局的独立路径并常需中国数据。
  • 本地决策权投入不足。 没有真实管线权限的中心沦为昂贵联络处；赢家授予中国团队真正的开发授权。
  • 上市前才想报销。 决定商业成败的常是医保目录与集采结果，而非注册批件。
  • 单一赛道过度集中。 中国优势面广（ADC、双抗、GLP-1、细胞治疗、放射配体），单主题下注浪费了生态。

来源

  • 国家药品监督管理局（NMPA）——官方门户：https://www.nmpa.gov.cn
  • NMPA——英文门户：https://english.nmpa.gov.cn
  • 国务院《利用外资固稳促优行动方案》（2026-06，商资发〔2026〕97号）：https://www.gov.cn/zhengce/zhengceku/202606/content_7072838.htm
  • 国务院新闻办发布会介绍利用外资固稳促优政策措施（2026-06）：https://www.gov.cn/lianbo/fabu/202606/content_7074496.htm

相关阅读

  • 参见：医疗医药准入（药监局） / Healthcare & pharma market access (NMPA)
  • 参见：医药产业开放新措施 / Pharma opening measures under the 2026 action plan
Visa-Free Transit / 过境免签

240-hour transit visa-free and unilateral visa waivers: easier China entry in 2026

  • China has extended transit visa-free stay to 240 hours (10 days) for eligible travellers from 55 countries.
    中国已将55个国家的合资格旅客过境免签停留时间延长至240小时（10天）。
  • The 240-hour transit visa-free policy now applies at 65 ports across 24 provincial-level regions, up from 39 ports and 19 regions.
    240小时过境免签政策现已覆盖24个省级行政区的65个口岸，较此前的39个口岸、19个地区进一步扩大。
  • China grants unilateral visa-free entry to 50 countries, with the policy extended through 31 December 2026.
    中国对50个国家实行单方面免签入境，该政策已延长至2026年12月31日。
  • Transit visa-free visitors may travel across provincial borders within the allowed stay areas.
    过境免签旅客可在允许的停留区域内跨省流动。
  • Visa-free inbound tourists reached 2.92 million in the 2026 New Year holiday, up 35.8% year on year.
    2026年新年假期，免签入境游客达292万人次，同比增长35.8%。

240-hour transit visa-free and unilateral visa waivers: easier China entry in 2026 | 240小时过境免签与单方面免签：2026年更便利的来华通道

Overview

China’s inbound-travel facilitation accelerated sharply in 2024 and 2025, and the momentum carried into 2026. Two complementary instruments now make short-term China entry substantially easier for foreign business travellers, investors and tourists: the 240-hour transit visa-free scheme and a broad set of unilateral visa waivers.

On 17 December 2024, the National Immigration Administration (NIA) announced a major widening of the transit visa-free policy: the permitted stay was extended from 72/144 hours to 240 hours (10 days); the number of eligible countries rose from 54 to 55; applicable ports increased from 39 to 60; and the covered provincial-level regions grew from 19 to 24. Crucially, cross-provincial travel within the designated stay areas was permitted for the first time.

By March 2026, a consulate update confirmed the 240-hour policy had further expanded to 65 ports across 24 provincial-level regions. Separately, China’s unilateral visa-free programme now covers 50 countries, extended through 31 December 2026, alongside comprehensive mutual visa-free arrangements with 29 countries.

The 240-hour transit visa-free scheme

Eligibility

The scheme applies to passport holders of 55 countries who hold:

  • a confirmed onward ticket to a third country or region;
  • a valid visa or residence permit for that onward destination (where required); and
  • entry through one of the designated ports.

Travellers must enter and exit via the approved ports and remain within the permitted stay areas during the 240-hour window.

Ports and regions

The policy now operates at 65 ports spanning 24 provincial-level regions. The expansion from 39 ports / 19 regions (the pre-December-2024 baseline) means many more cities — including major commercial hubs — are now entry points. This is materially relevant for business visitors who previously had to route through a limited set of gateway cities.

Cross-provincial movement

Unlike the older 72/144-hour schemes, which locked travellers into a single city or province, the 240-hour policy allows movement across provincial borders within the allowed stay areas. This supports multi-city business itineraries (e.g., Shanghai → Zhejiang → Jiangsu) without a formal visa.

Unilateral visa waivers

China grants unilateral visa-free entry to 50 countries, a policy originally introduced as a post-pandemic recovery measure and repeatedly extended. As of 2026, it is confirmed through 31 December 2026. In addition, China maintains comprehensive mutual visa-free agreements with 29 countries.

Practical implications:

  • Nationals of these 50 countries may enter China for short stays (tourism, business, family visits) without obtaining a visa in advance.
  • The unilateral measure is a sovereign policy choice and can be adjusted; travellers should verify current eligibility before departure.
  • Combined with the transit scheme, the two instruments cover a very large share of prospective foreign business visitors.

Impact and demand signals

Demand confirms the policy is working. During the 2026 New Year holiday, visa-free inbound tourists reached 2.92 million, representing 35.8% year-on-year growth. The surge reflects both the breadth of the waiver coverage and the removal of friction in short-term entry.

For foreign investors and market-entry teams, the practical upside is direct:

  • Reconnaissance trips — visiting factories, partners and regulators without visa lead time.
  • Meeting-driven travel — multi-city roadshows and due-diligence visits under the cross-provincial rule.
  • Faster onboarding — short-stay entry for technical staff and consultants during setup.

Practical guidance for business travellers

  • Check the country list against the latest NIA and consulate notices before booking; lists are updated periodically.
  • Choose an eligible port — confirm both arrival and departure airports/ports are on the 65-port list.
  • Prepare onward proof — keep confirmed tickets and, where needed, the third-country visa.
  • Plan routes within stay areas — leverage cross-provincial freedom but respect the boundary of permitted regions.
  • Do not overstay — the 240-hour clock starts at entry; overstaying triggers penalties and future-entry risk.

Sources

240小时过境免签与单方面免签：2026年更便利的来华通道

概述

中国入境旅行便利化在2024与2025年显著提速，并延续至2026年。两套互补机制让外国商务旅客、投资者与游客的短期来华大幅便利：其一是240小时过境免签制度，其二是范围广泛的单方面免签安排。

2024年12月17日，国家移民管理局宣布大幅放宽过境免签政策：允许停留时间由72/144小时延长至240小时（10天）；适用国家由54个增至55个；适用口岸由39个增至60个；覆盖的省级行政区由19个增至24个。关键的是，首次允许在限定停留区域内跨省流动。

至2026年3月，领事机构更新确认，240小时政策已进一步扩展至24个省级行政区的65个口岸。与此同时，中国的单方面免签计划已覆盖50个国家，并延长至2026年12月31日；此外还与29个国家达成全面互免签证安排。

240小时过境免签制度

适用条件

该制度适用于55个国家的护照持有人，且须满足：

  • 持有前往第三国或地区的已确认联程客票；
  • 持有该目的地所需的有效签证或居留许可（如需要）；
  • 经指定的对外开放口岸入境。

旅客须经由批准的口岸入出境，并在240小时窗口期内停留在允许的区域内。

口岸与区域

该政策现于24个省级行政区的65个口岸实施。相较2024年12月前的39个口岸、19个地区，许多商业枢纽城市成为新的入境点。对商务访客而言，这意义重大——以往只能经由少数门户城市中转。

跨省流动

与旧版72/144小时制度将旅客锁定在单一城市或省份不同，240小时政策允许在允许的停留区域内跨省流动。这支持多城市商务行程（如上海→浙江→江苏），而无需正式签证。

单方面免签

中国对50个国家实行单方面免签入境，该政策最初作为疫后复苏措施推出，并多次延长。截至2026年，已确认延长至2026年12月31日。此外，中国与29个国家保持全面互免签证安排。

实际影响：

  • 这50个国家的公民可免预先签证短期来华（旅游、商务、探亲）。
  • 单方面措施为主权政策选择，可随时调整；旅客应在出发前核实当前资格。
  • 与过境制度结合，两套机制覆盖了绝大多数潜在外国商务访客。

影响与需求信号

需求数据印证了政策成效。2026年新年假期，免签入境游客达292万人次，同比增长35.8%。这一激增既反映出免签覆盖之广，也体现出短期入境摩擦的消除。

对外国投资者与市场进入团队而言，实际利好直接可见：

  • 考察行程——无需签证准备时间即可走访工厂、合作伙伴与监管方。
  • 以会议为导向的出行——借助跨省规则开展多城市路演与尽职调查。
  • 更快的人员到位——设立期间短期入境技术人员与顾问。

商务旅客实操建议

  • 核对国家清单——出行前对照NIA及领事机构最新通知，清单会定期更新。
  • 选择合格口岸——确认入境与离境机场/口岸均在65个口岸清单内。
  • 准备过境凭证——保留已确认客票，并在需要时备妥第三国签证。
  • 在停留区域内规划路线——善用跨省自由，但遵守允许区域的边界。
  • 切勿逾期——240小时自入境起算，逾期将触发处罚及未来入境风险。

来源

Visa-Free Transit / 过境免签

China Expands 240-Hour Visa-Free Transit to 57 Countries: New Options for Business Travelers (August 2026)

  • From 20 August 2026, nationals of Kyrgyzstan and Vietnam can use China’s 240-hour visa-free transit policy and Hainan’s 30-day visa-free entry policy, raising the eligible country counts to 57 and 61 respectively.
    自 2026 年 8 月 20 日起，吉尔吉斯斯坦、越南公民可适用 240 小时过境免签与海南 30 天入境免签政策，两项政策的适用国家分别增至 57 国与 61 国。
  • Eligible travellers holding ordinary passports and confirmed interline tickets can enter through any of 65 open ports, including Beijing and Shanghai, and stay up to 240 hours (10 days) within designated areas.
    持普通护照与确定日期及行程联程客票的旅客，可从北京、上海等 65 个对外开放口岸免签入境，并在规定区域内免签停留不超过 240 小时。
  • Vietnamese and Kyrgyz nationals with ordinary passports may enter through any open port of Hainan and stay up to 30 days within the province.
    吉、越两国公民持普通护照可由海南省对外开放口岸入境，在海南省行政区域内免签停留不超过 30 天。
  • The visa-free stays cover tourism, business, visits and family visits; work, study and news reporting still require a visa obtained before arrival.
    免签停留可从事旅游、商贸、访问、探亲等短期活动；工作、学习、新闻采访等仍需在来华前办妥签证。
  • Vietnam was China’s fourth-largest source of inbound travellers in H1 2026, and border traffic between the two countries has grown sharply, making the expansion commercially significant.
    2026 年上半年越南是中国第四大入境游客来源国，两国间口岸往来快速增长，本次扩围的商业意义显著。
  • For foreign-invested employers and business travellers, the expansion lowers entry friction for meetings, inspections and short assignments, but residence permit and work-permit routes remain unchanged.
    对外资企业与商务旅客而言，本次扩围降低了会议、考察与短期任务的入境门槛，但居留许可与工作许可路径保持不变。

China Expands 240-Hour Visa-Free Transit to 57 Countries: New Options for Business Travelers (August 2026) | 中国 240 小时过境免签扩至 57 国：外籍商务旅客的新选项（2026 年 8 月）

Why this matters now

On 20 August 2026, the National Immigration Administration (NIA) announced that nationals of Kyrgyzstan and Vietnam would become eligible for China’s 240-hour visa-free transit policy and Hainan’s 30-day visa-free entry policy with immediate effect. The 240-hour transit scheme now covers 57 countries and the Hainan scheme 61 countries. The change is part of a steady widening of China’s short-term entry facilitation since the scheme was extended from 72/144 hours to 240 hours in December 2024, and it matters for multinational companies because two neighbouring, high-volume source markets — Vietnam and Central Asia’s Kyrgyzstan — now enjoy visa-free access for precisely the kind of short, business-driven trips that previously required advance visa arrangements.

What the August 2026 expansion means in practice

Under the NIA announcement (No. 4 of 2026), citizens of Kyrgyzstan and Vietnam who hold an ordinary passport and a confirmed interline ticket with a fixed date and itinerary, and who are transiting through China to a third country or region, may enter visa-free through any of the 65 designated open ports, including Beijing and Shanghai, and stay up to 240 hours in the designated areas. The same two nationalities may alternatively enter through any open port of Hainan Province and stay up to 30 days. The eligible activities are tourism, business, visits and family visits. Work, study and news reporting still require an advance visa, and travellers who plan to stay beyond the limits or leave the designated areas must use the ordinary visa or residence-permit route.

For foreign-invested enterprises, the practical benefit is lower friction for short trips: factory inspections, supplier meetings, trade-fair attendance, client visits and board-level discussions that fall within 10 days can now be handled visa-free for citizens of the 57 covered countries. Vietnam was China’s fourth-largest source of inbound travellers in the first half of 2026, after Korea, Russia and Malaysia, and the Hekou port on the Yunnan–Vietnam border alone recorded more than 4 million border crossings by mid-August. Kyrgyzstan’s Torugart port on the Xinjiang border also saw a 60% year-on-year increase in trips in the first quarter of 2026, so the policy is expected to accelerate both business and tourism traffic.

Practical steps for employers and travellers

  1. Confirm eligibility before booking. Check that the traveller’s nationality is on the 57-country list and that the itinerary is a genuine transit to a third country or region with a confirmed onward ticket.
  2. Stay within the 240-hour window and the designated area. Overstaying or travelling outside the approved region converts a facilitation into an immigration compliance issue; the 10-day cap counts from arrival.
  3. Choose the right route for longer stays. If the purpose is work, study or journalism, or the stay exceeds the visa-free limit, apply for the appropriate visa or work/residence permit before arrival — the visa-free schemes do not replace these.
  4. For Hainan-specific travel, note that the 30-day entry is limited to the province; leaving Hainan for the mainland requires an appropriate permit or visa.
  5. Keep documents consistent. Immigration officers verify the ordinary passport and the interline ticket; name and date mismatches can cause denial at the port.
  6. Plan compliance updates. Multinational HR and mobility teams should update internal travel policies and visa matrices so that short business trips to China use the right, fastest legal channel.

Compliance notes

The expansion is a facilitation of short-term entry, not a change to China’s work and residence framework. Foreign employees who enter visa-free cannot simply begin working in China; the work-permit and work-type residence permit route, and the foreigner work permit classification system, remain mandatory for employment. Employers should also be aware that the transit area restrictions differ by port group, and that the authorities retain the right to require a visa when circumstances suggest the traveller does not genuinely intend to transit. Finally, policies at the operational level — port lists, airline cooperation and regional implementation — can be adjusted by the NIA without notice, so verify the current rules before each trip. For 2026 planning, treat the August expansion as a baseline and re-check before each itinerary, because the 240-hour and Hainan schemes continue to evolve in both country coverage and port lists.

中国 240 小时过境免签扩至 57 国：外籍商务旅客的新选项（2026 年 8 月）/ China Expands 240-Hour Visa-Free Transit to 57 Countries: New Options for Business Travelers (August 2026)

为什么当下重要

2026 年 8 月 20 日，国家移民管理局发布公告，自当日起对吉尔吉斯斯坦、越南公民实施 240 小时过境免签政策和海南 30 天入境免签政策。至此，240 小时过境免签政策适用国家增至 57 国，海南 30 天入境免签政策适用国家增至 61 国。此次调整是 2024 年 12 月免签停留时长从 72/144 小时延长至 240 小时后，中国持续放宽短期入境的又一步。对跨国企业而言，两个邻近且客流量大的来源市场——越南与中亚的吉尔吉斯斯坦——如今对这类过去需要提前办签的短期商务差旅，享受免签入境。

2026 年 8 月扩围的实操含义

根据国家移民管理局 2026 年第 4 号公告，吉尔吉斯斯坦、越南公民持普通护照和确定日期及行程的联程客票，从中国过境前往第三国或地区，可从北京、上海等 65 个对外开放口岸免签入境，并在规定区域内免签停留不超过 240 小时。两国公民也可选择持普通护照从海南省对外开放口岸入境，在海南省行政区域内免签停留不超过 30 天。适用上述政策的来华活动包括旅游、商贸、访问、探亲等短期活动；工作、学习、新闻采访等仍应在来华前办妥签证，计划超期停留或离开规定区域的旅客须走普通签证或居留许可路径。

对外资企业而言，实际好处在于短期差旅摩擦降低：工厂考察、供应商会谈、参展、客户拜访、董事会讨论等 10 天以内的行程，覆盖名单内 57 国公民现在可以免签完成。2026 年上半年越南是中国第四大入境游客来源国（仅次于韩国、俄罗斯、马来西亚），仅云南河口口岸与越南的出入境人数到 8 月中旬累计已超 400 万人次；新疆的吐尔尕特口岸一季度出入境人次同比增 60%。预计该政策将同时带动商务与旅游往来。

雇主与旅客的操作步骤

  1. 预订前确认资格。 核验旅客国籍是否在 57 国名单内，且行程确为前往第三国或地区的过境，并持有确认的联程机票。
  2. 控制 240 小时与限定区域。 超期停留或离开批准区域会使便利措施变成出入境合规问题；10 天上限自入境起算。
  3. 更长的停留选择正确路径。 若目的为工作、学习或新闻采访，或停留超出免签时限，应在来华前申请相应签证或工作/居留许可——免签政策不替代这些安排。
  4. 海南专项行程注意。 30 天入境限定在省内；离开海南进入内地需相应许可或签证。
  5. 保持证件信息一致。 边检核验普通护照与联程客票；姓名、日期不符可能导致口岸拒绝入境。
  6. 同步更新合规材料。 跨国 HR 与差旅团队应更新内部出行政策与签证矩阵，确保赴华短期商务行程走正确、最快的合法通道。

合规提示

本次扩围是短期入境的便利化，不是中国工作与居留框架的变化。以免签身份入境的外籍员工不能直接开始在华工作；工作许可、工作类居留许可以及外国人工作许可分类管理路径对就业仍然强制适用。雇主还应留意，过境停留区域限制因口岸群而异，且当情况显示旅客并非真实过境时，主管机关保留要求办理签证的权力。最后，口岸名单、航司合作与地区落地细则可能由国家移民管理局随时调整，每次出行前应核实现行规则。

Sources

Visa-Free Transit / 过境免签

China’s 240-Hour Visa-Free Transit: Ports, Provinces and Business-Travel Practice (2026)

  • China’s 240-hour visa-free transit lets eligible nationals of 55 countries transit to a third destination via 65 ports across 24 provincial-level regions, staying up to 10 days without a visa.
    中国240小时过境免签允许55国合资格人员经24个省区市的65个口岸前往第三国（地区），免签停留最长10天。
  • In its first year the policy drove 40.6 million inbound foreign arrivals (+27.2% yoy), with 240-hour users up 60.8% versus the pre-optimisation baseline.
    实施首年带动全国各口岸入境外籍人员4060万人次（同比+27.2%），240小时适用人数较优化前增60.8%。
  • The November 2025 expansion added Guangzhou, Hengqin, Zhongshan, the HK–Zhuhai–Macao Bridge and West Kowloon as new ports, raising the total from 60 to 65.
    2025年11月扩围新增广州、横琴、中山、港珠澳大桥及西九龙等口岸，总数由60增至65。
  • Eligible activities during stay include tourism, business, visiting and family; the stay area spans 24 provinces, with some provinces open province-wide.
    停留期间可从事旅游、商务、访问、探亲等活动；停留区域覆盖24个省区，部分省份全省开放。
  • A separate unilateral visa exemption for 40+ countries was extended to 31 December 2026, complementing the transit scheme for short visits.
    面向40多个国家的单边免签已延长至2026年12月31日，与过境方案形成短期访问互补。
  • Practical step: confirm nationality and onward-ticket, enter via a designated port, and respect the stay area and 240-hour clock for business visits.

实操建议：确认国籍与联程机票，经指定口岸入境，并遵守停留区域与240小时时限以商务访问。

China’s 240-Hour Visa-Free Transit: Ports, Provinces and Business-Travel Practice (2026) | 240小时过境免签扩围：口岸、适用省份与商务旅行实务（2026）

China’s transit visa-free programme is one of the most tangible openings for business travellers. The 240-hour (10-day) visa-free transit now covers eligible nationals of 55 countries entering via 65 ports in 24 provincial-level regions for a stay of up to 10 days before proceeding to a third country or region. For foreign investors doing site visits, trade fairs and partner meetings, the scheme removes a major friction point.

How the policy expanded

The National Immigration Administration (NIA) first extended the stay from 72/144 hours to 240 hours and widened the ports and areas in a major relaxation. A November 2025 update added Guangzhou, Zhuhai’s Hengqin and Zhongshan, the Hong Kong–Zhuhai–Macao Bridge and the West Kowloon Station of the Guangzhou–Shenzhen–Hong Kong Express Rail Link, lifting the eligible ports from 60 to 65. The stay area grew to 24 provincial-level regions; Anhui, Hainan and Guizhou are open province-wide, while Shanxi (Taiyuan/Datong) and Jiangxi (Nanchang/Jingdezhen) are partially open. Travellers may move across the designated areas of the 24 regions.

Who and what

Eligible persons are nationals of 54–55 specified countries transiting to a third destination. During the stay they may engage in tourism, business, visiting and family activities — which covers the typical foreign-invested-enterprise scenario of a short inspection, a trade fair or a board meeting. A separate unilateral visa exemption for more than 40 countries (including France, Germany, Italy, the Netherlands, Spain and Sweden) was extended to 31 December 2026, giving another channel for short visits.

The impact

One year after implementation, inbound foreign arrivals through all ports reached 40.6 million (+27.2% year-on-year), and 240-hour transit users grew 60.8% over the pre-optimisation baseline. The NIA also let foreign travellers complete entry cards online before arrival from 20 November 2025. The momentum reflects both demand and China’s push for “institutional opening” in personnel exchange.

Practical business-travel steps

  1. Confirm eligibility. Check that your nationality is on the 55-country list and that you hold an onward ticket to a third country/region.
  2. Enter at a designated port. Use one of the 65 ports; confirm the specific terminal (e.g., the bridge or rail station) accepts transit.
  3. Respect the stay area. Travel only within the 24 designated regions; note province-wide vs partial openings.
  4. Mind the clock. The 240 hours run from entry; plan departure before expiry.
  5. Keep documents. Carry the onward ticket and accommodation/business-meeting proof if asked.

240小时过境免签扩围：口岸、适用省份与商务旅行实务（2026）

中国的过境免签是商务旅客感受最直观的开放举措。240小时（10天）过境免签现覆盖55国合资格人员，经24个省区市的65个口岸入境，前往第三国或地区前可免签停留最长10天。对来华考察、参展、会晤合伙人的外资人士而言，该政策消除了主要摩擦点。

政策如何扩围

国家移民管理局先将停留时间由72/144小时延长至240小时，并在一次大幅优化中扩大口岸与区域。2025年11月更新新增广州、珠海横琴、中山、港珠澳大桥及广深港高铁西九龙站等口岸，使适用口岸由60增至65。停留区域增至24个省区市；安徽、海南、贵州全省开放，山西（太原/大同）、江西（南昌/景德镇）部分开放。旅客可在24个区域的指定范围内跨省旅行。

适用对象与活动

合资格者为前往第三国（地区）的54–55个指定国家人员。停留期间可从事旅游、商务、访问、探亲——涵盖外商投资企业典型的短期考察、参展或董事会场景。面向40多个国家的单边免签（含法国、德国、意大利、荷兰、西班牙、瑞典等）已延长至2026年12月31日，为短期访问提供另一通道。

实施成效

实施一年来，全国各口岸入境外籍人员达4060万人次（同比+27.2%），240小时适用人数较优化前增60.8%。国家移民管理局自2025年11月20日起允许外籍旅客抵前在线填妥入境卡。这一势头既反映需求，也体现中国在人员往来领域”制度型开放”的推进。

商务旅行实操步骤

  1. 确认资格。 核对国籍在55国名单内，并持前往第三国（地区）的联程机票。
  2. 经指定口岸入境。 使用65个口岸之一；确认具体场站（如大桥或高铁站）受理过境。
  3. 遵守停留区域。 仅在24个指定区域内旅行；注意全省开放与部分开放之别。
  4. 留意时限。 240小时自入境起算，须在期满前离境。
  5. 备妥证件。 随身带联程机票及住宿/商务会晤证明以备查验。

What Changed in the Latest Round

The November 2025 relaxation was the most significant since the programme began. It added Guangzhou’s airports, Zhuhai’s Hengqin and Zhongshan, the Hong Kong–Zhuhai–Macao Bridge and the West Kowloon Station of the Guangzhou–Shenzhen–Hong Kong Express Rail Link as new 240-hour transit ports, raising the total from 60 to 65. The stay area expanded to 24 provincial-level regions, with Anhui, Hainan and Guizhou open province-wide. Alongside this, the unilateral visa exemption for more than 40 countries was extended to 31 December 2026, and foreign travellers were allowed to complete entry cards online before arrival from 20 November 2025. For business visitors, the practical effect is a near-seamless short stay for site visits, trade fairs and board meetings without a formal visa.

本轮2025年11月的放松是该项目启动以来力度最大的一次。新增广州机场、珠海横琴与中山、港珠澳大桥、广深港高铁西九龙站等为240小时过境口岸，总数由60增至65。停留区域扩至24个省区市，安徽、海南、贵州全省开放。与此同时，面向40多个国家的单边免签延长至2026年12月31日，自2025年11月20日起外籍旅客可抵前在线填妥入境卡。对商务访客而言，实地考察、参展与董事会等短期停留近乎无缝，无需正式签证。

Practitioner Quick Reference

  • 55 countries, 65 ports, 24 regions, 240 hours: the headline parameters of the transit scheme.
    55国、65口岸、24区域、240小时：过境方案的核心参数。
  • New ports: Guangzhou, Hengqin, Zhongshan, the HK–Zhuhai–Macao Bridge and West Kowloon.
    新增口岸：广州、横琴、中山、港珠澳大桥、西九龙。
  • Activities allowed: tourism, business, visiting and family — covers inspections, fairs and meetings.
    允许活动：旅游、商务、访问、探亲——涵盖考察、参展与会议。
  • Unilateral visa-free complements: 40+ countries exempt to 31 Dec 2026 for short visits.
    单边免签互补：40多国免签至2026年12月31日，适用短期访问。
  • Online entry cards: complete the card before arrival from 20 Nov 2025.
    在线入境卡：自2025年11月20日起可抵前填妥。

Common Pitfalls

  • Wrong port: entering via a non-designated port breaks the transit eligibility.
    口岸不符：经非指定口岸入境即丧失过境资格。
  • Overstaying the area: leaving the 24 designated regions violates the condition.
    越出区域：离开24个指定区域即违规。
  • Missing the clock: the 240 hours run from entry; plan the outbound leg in time.
    忽视时限：240小时自入境起算，须及时安排离境行程。

2026 Watchlist

  • Further port additions: more airports and rail stations may be added to the 65-port list.
    口岸再增：更多机场与高铁站或纳入65口岸清单。
  • Unilateral visa-free expansion: the 40+ country list may extend beyond 31 Dec 2026.
    单边免签扩国：40多国免签名单或延至2026年12月31日之后。
  • Entry-card digitisation: online pre-arrival cards may expand to more traveller types.
    入境卡数字化：抵前在线填卡或扩至更多旅客类型。

Key Figures

  • 55 countries: nationalities eligible for the 240-hour transit scheme.
    55国：适用240小时过境免签的国家。
  • 65 ports: designated entry ports after the November 2025 expansion.
    65个口岸：2025年11月扩围后的指定入境口岸。
  • 24 regions: provincial-level areas open for the stay.
    24个区域：开放停留的省区市。
  • 40.6 million: inbound foreign arrivals in the first year (+27.2% yoy).
    4060万人次：实施首年入境外籍人员（同比+27.2%）。

Sources

Visa-Free Transit / 过境免签

Visa Facilitation for Business Visitors to China in 2026: Transit, Unilateral and Port-Visa Options Compared

  • China now offers business visitors three layered, non-exclusive entry conveniences — 240-hour transit visa-free, unilateral visa-free for 50 countries, and port visa / APEC Business Travel Card — and choosing the right one depends on itinerary, nationality and purpose.
    中国目前为商务访客提供三层叠加、互不排斥的入境便利——240小时过境免签、对50国的单方面免签，以及口岸签证与APEC商务旅行卡；正确选择取决于行程、国籍与目的。
  • The 240-hour (10-day) transit visa-free scheme covers 55 countries, 65 open ports across 24 provinces, and permits tourism, business, visits and family reunions during the stay.
    240小时（10天）过境免签覆盖55个国家、24个省份的65个开放口岸，停留期间可从事旅游、商务、访问与探亲活动。
  • As of 17 February 2026, China applies unilateral visa-free entry to 50 countries for stays up to 30 days for business, tourism, family visits, exchanges and transit.
    截至2026年2月17日，中国对50个国家实施单边免签，因经商、旅游观光、探亲访友、交流访问、过境事由来华可免签停留不超过30日。
  • Regional entry visa-free schemes — Hainan (59 countries, 30 days), cruise tours, ASEAN tour groups and HK/Macau-organsied foreign tour groups into the Greater Bay Area or Hainan — open targeted corridors for business-and-leisure combinations.
    区域性入境免签——海南（59国、30天）、邮轮免签、东盟旅游团免签，以及经港澳旅行社组团免签进入大湾区或海南——为”商务+休闲”组合打开了定向通道。
  • Port visas let qualifying foreign business visitors obtain a visa on arrival at designated ports when an invitation letter and supporting documents are ready, and the APEC card enables multi-year, multi-economy transit.
    口岸签证允许符合条件的外国商务人员凭邀请函等证明材料在指定口岸落地办证，APEC商务旅行卡则实现多年期、多经济体的通行。
  • None of these substitutes for a work or study visa; paid employment, study and news reporting still require prior approval, and overstayers face fines, detention and future-entry bans.
    上述任何一项都不能替代工作或学习签证；有偿就业、留学与新闻采访仍须事先批准，逾期停留将面临罚款、拘留与未来入境限制。

Visa Facilitation for Business Visitors to China in 2026: Transit, Unilateral and Port-Visa Options Compared | 2026年外国商务人员来华免签与口岸签证便利：过境免签、单方面免签与口岸签证对照

Why this matters now

Easing the movement of people is now a stated tool of investment promotion. The *Action Plan for Stabilising and Optimising Foreign Investment* (MOFCOM, NDRC and MOF, Document No. 97 of 2026) explicitly lists transit visa-free, tax-refund-on-departure and cross-border payment measures among the ways China optimises the internationalised business environment. For the foreign executive weighing a week of client meetings, a factory inspection or a board session in China, the visa question is often the first friction point. The good news: the default answer is increasingly “you may not need a visa at all,” provided the itinerary fits one of three layered schemes.

This article compares the 240-hour transit visa-free programme, the unilateral visa-free list, the regional entry schemes and the port-visa / APEC options, and gives a practical decision checklist. It complements — but does not duplicate — our companion pieces on work visas and the APEC Business Travel Card.

The 240-hour transit visa-free programme

The flagship convenience is the 240-hour (10-day) transit visa-free policy. A national of one of 55 designated countries, holding a valid international travel document and a connecting ticket with a confirmed date and seat to a third country or region, may enter visa-free through any of 65 open ports in 24 provinces and stay up to 10 days. During the stay, permitted activities include tourism, business, visiting and family reunion. Paid work, study and news reporting still require prior approval.

The scheme has been upgraded repeatedly: from 72 hours (2013), to 144 hours, to 240 hours, with the country list growing to 55 and ports to 65 by late 2025. For a business visitor transiting through China en route to a third country — say, Tokyo → Shanghai → Frankfurt — the 240-hour window is usually ample for meetings without any visa application.

Unilateral visa-free for 50 countries

Beyond transit, China applies a unilateral visa-free policy to 50 countries (as published by the National Immigration Administration on 17 February 2026). Nationals of these countries, travelling on an ordinary passport for business, tourism, family visits, exchanges or transit of no more than 30 days, may enter visa-free. The list spans Europe (35 countries, including France, Germany, Italy, the UK, Russia and the Nordics), Oceania (Australia, New Zealand), Asia (Japan, South Korea, Saudi Arabia, the Gulf states) and the Americas (Brazil, Argentina, Chile, Peru, Uruguay, Canada).

This is the single most useful instrument for short business development trips: a German or Brazilian executive can fly in, attend meetings, sign a term sheet and leave within 30 days with no consular step. It is unilateral — China grants it without reciprocity — and can be adjusted, so travellers should confirm the current list before booking.

Regional entry visa-free schemes

A family of *regional* schemes opens targeted corridors, useful when the trip blends business with leisure or centres on a specific zone:

  • Hainan: nationals of 59 countries may enter visa-free and stay up to 30 days.
  • Cruise tours: foreign tour groups of two or more may enter visa-free through 13 cruise ports along coastal provinces and Beijing, staying up to 15 days.
  • ASEAN tour groups: ASEAN nationals may enter visa-free as tour groups into Xishuangbanna (Yunnan) or Guilin (Guangxi), up to 6 days.
  • HK/Macau-organised foreign tour groups: foreign groups organised by HK or Macau travel agencies may enter the nine mainland cities of the Greater Bay Area plus Shantou, or Hainan, visa-free for up to 6 days.

For an investor combining site visits in the Greater Bay Area with a short holiday, the HK/Macau-group route is a practical, low-friction option.

Port visa and APEC Business Travel Card

When a trip does not fit the above — for example, a last-minute technical assignment, or a nationality outside the eligible lists — a port visa remains available. Qualifying foreign business visitors may, with an invitation letter from a domestic entity and supporting documents, apply for a visa on arrival at designated ports. Processing is fast and designed for genuine, time-sensitive commercial need.

The APEC Business Travel Card offers a multi-year, multi-economy shortcut for senior executives from APEC economies: it functions as a multiple-entry visa and enables expedited immigration lanes across member economies, materially cutting the administrative load of repeated travel. We cover it in detail separately.

Practical decision checklist

  1. Transiting to a third country? Use 240-hour transit visa-free (55 countries, 65 ports, 24 provinces).
  2. From one of the 50 unilateral countries, stay ≤30 days, no work/study? Enter visa-free directly.
  3. Trip centres on Hainan / a cruise / an ASEAN or HK-Macau group? Use the matching regional scheme.
  4. Eligible APEC economy executive with frequent travel? Hold an APEC card.
  5. None of the above, or paid work / study / reporting? Obtain the correct visa (port visa for urgent business; work/residence permit for employment).
  6. Always: confirm the current eligible-country list and port list before ticketing, carry the onward ticket, and never overstay.

Related reading

  • Work visas and residence permits for foreign employees in China.
  • The APEC Business Travel Card and port-visa routes for business travellers.
  • Regional visa-free entry schemes and the Greater Bay Area mobility picture.

2026年外国商务人员来华免签与口岸签证便利：过境免签、单方面免签与口岸签证对照

为何重要

便利人员往来已成为引资促商的一项明确工具。《利用外资固稳促优行动方案》（商务部、国家发展改革委、财政部，2026年第97号）明确将过境免签、离境退税与涉外支付等措施列为优化国际化营商环境的具体抓手。对于正盘算一周客户拜访、工厂巡查或董事会行程的外国高管而言，签证往往是第一道摩擦点。好消息是：只要行程契合三层便利方案之一，答案越来越可能是”你根本不需要签证”。

本文对比240小时过境免签、单方面免签清单、区域性入境免签，以及口岸签证与APEC选项，并给出实用的决策清单。它与本站点关于工作签证、APEC商务旅行卡的专文互为补充，但不重复。

240小时过境免签方案

最具标志性的便利是240小时（10天）过境免签。55个指定国家的公民，持有效国际旅行证件和前往第三国（地区）且日期、座位已确定的联程客票，可从24个省份的65个开放口岸免签入境，停留不超过10天。停留期间可从事旅游、商务、访问、探亲等活动；有偿工作、留学与新闻采访仍须事先批准。

该方案历经多次升级：从2013年的72小时，到144小时，再到240小时，适用国家增至55个、口岸增至65个（2025年底）。对于经中国中转前往第三国的商务访客——例如东京→上海→法兰克福——240小时窗口通常足以完成会议而无需任何签证申请。

对50国的单方面免签

在过境之外，中国对50个国家实施单方面免签（国家移民管理局2026年2月17日公布）。这些国家公民持普通护照，因经商、旅游观光、探亲访友、交流访问、过境事由来华、停留不超过30日的，可免签入境。清单覆盖欧洲（35国，含法国、德国、意大利、英国、俄罗斯及北欧国家）、大洋洲（澳大利亚、新西兰）、亚洲（日本、韩国、沙特及海湾国家）与美洲（巴西、阿根廷、智利、秘鲁、乌拉圭、加拿大）。

这是短期商务拓展行程最实用的工具：德国或巴西高管可以飞抵、参会、签署条款清单并在30天内离境，无需任何领事步骤。该政策是单边的（中国单方面给予、不要求对等），并可能调整，出行人应在订票前确认最新清单。

区域性入境免签方案

一族*区域性*方案打开了定向通道，适用于”商务+休闲”结合或围绕特定区域的行程：

  • 海南： 59国公民可免签入境，停留不超过30天。
  • 邮轮免签： 2人及以上外国旅游团可经13个邮轮口岸及北京市免签入境沿海省（区、市），停留不超过15天。
  • 东盟旅游团： 东盟国家旅游团可分别免签入境云南西双版纳或广西桂林，停留不超过6天。
  • 港澳组团： 经港澳旅行社组团的外国旅游团，可免签进入大湾区内地9市及汕头，或免签入境海南，停留不超过6天。

对于将大湾区实地考察与短途休假结合的投资者，港澳组团路线是务实、低摩擦的选择。

口岸签证与APEC商务旅行卡

当行程不符合上述情形——例如临时的技术派驻，或国籍不在适用清单内——口岸签证仍是可行路径。符合条件的外国商务人员，凭国内单位邀请函及证明材料，可在指定口岸落地申请签证。办理快捷，专为真实、时效敏感的商务需求设计。

APEC商务旅行卡为APEC经济体高管提供多年期、多经济体的通行捷径：兼具多次入境签证功能，并在成员经济体间启用快速通道，显著降低频繁出行的行政负担。本站点另有专文详述。

实用决策清单

  1. 经第三国中转？ 用240小时过境免签（55国、65口岸、24省）。
  2. 来自50个单方面免签国、停留≤30天、无工作/留学？ 直接免签入境。
  3. 行程围绕海南/邮轮/东盟或港澳组团？ 用对应的区域性方案。
  4. 属APEC经济体、频繁出行的高管？ 持有APEC卡。
  5. 以上均不符合，或有偿工作/留学/采访？ 办理相应签证（紧急商务走口岸签证；就业办工作居留许可）。
  6. 始终： 订票前确认最新适用国家与口岸清单，携带后续行程客票，切勿逾期。

延伸阅读

  • 外籍员工在华的工作签证与居留许可。
  • APEC商务旅行卡与面向商务人员的口岸签证路径。
  • 区域性入境免签方案与大湾区的人员流动图景。

Sources

  • 国家移民管理局：单方面免签国家名单（2026年2月17日）— https://nia.gov.cn/n741440/n741577/c1731154/content.html
  • 国家移民管理局：中国240小时过境免签政策（在线咨询答复，含55国/65口岸）— https://www.nia.gov.cn/Enquiry/publish/preShowQuestion.jsp
  • 国家移民管理局官网（签证政策与出入境管理专栏）— https://www.nia.gov.cn