Zhiheng Law Research... Biopharmaceutical industry investment and financing legal practice-pharmaceutical medical industry foreign investment access (above)- Zhiheng Law Firm

Authors | Yao Haishong, Attorney; Lou Mengqian, Attorney; Luo Yuting, Attorney, Zhiheng Shanghai Law Firm

Legal Practice for Investment and Financing in the Biopharmaceutical Industry---Foreign Investment Access in the Pharmaceutical and Medical Industry (Part 1)

On September 6, 2024, the National Development and Reform Commission (NDRC) and the Ministry of Commerce (MOFCOM) issued the Special Administrative Measures for Foreign Investment Access (Negative List) (2024 Edition) (hereinafter referred to as the "Negative List"). The Negative List stipulates that medical institutions are limited to Sino-foreign joint ventures and prohibits foreign investment in the development and application of human stem cell and gene diagnosis and treatment technologies. These provisions are consistent with the foreign investment access rules in the Special Administrative Measures for Foreign Investment Access (Negative List) (2021 Edition) and the Special Administrative Measures for Foreign Investment Access in Pilot Free Trade Zones (Negative List) (2021 Edition). However, the 2024 Negative List removed the foreign investment restrictions on "the application of processing techniques such as steaming, stir-frying, honey-frying and calcining of traditional Chinese medicine (TCM) decoction pieces and the production of TCM products with confidential formulas."

September 6, 2024On [date], the National Development and Reform Commission and the Ministry of Commerce released the “Special Management Measures for Foreign Investment Access (Negative List)”…2024 Edition) (hereinafter referred to as“Negative List”) stipulates that medical institutions are limited to Sino‑foreign joint ventures, and foreign investment in the development and application of human stem cell, gene diagnosis, and gene therapy technologies is prohibited, which is inconsistent with the “Special Management Measures for Foreign Investment Access (Negative List)”2021Year edition), “Special Management Measures for Foreign Investment Access in Free Trade Pilot Zones (Negative List)” (2021It remains consistent with the foreign investment access rules stipulated in the (Year Edition), but the provisions regarding… have been deleted.“The application of processing techniques such as steaming, stir-frying, honey-frying, and calcination in the preparation of traditional Chinese medicine decoction pieces, as well as the production of proprietary Chinese patent medicines with confidential formulas.foreign investment restrictions.

On September 7, 2024, the Ministry of Commerce (MOFCOM), the National Health Commission (NHC), and the National Medical Products Administration (NMPA) jointly issued the Notice on Carrying Out Pilot Work to Expand Openness in the Medical Field (hereinafter referred to as the "Medical Field Opening Pilot Notice"), proposing to carry out two pilot initiatives to expand openness in the medical field. On April 11, 2025, MOFCOM issued the Work Plan for Accelerating the Comprehensive Pilot Program for Expanding Openness in the Service Sector, proposing to enhance the level of openness and service support in the medical and health care sector. It allows the establishment of non-profit medical institutions through Sino-foreign joint donations according to relevant regulations and permits foreign investors to donate funds to establish non-profit elderly care institutions.

September 7, 2024On [date], the Ministry of Commerce, the National Health Commission, and the National Medical Products Administration jointly issued the “Notice on Carrying Out Pilot Programs to Expand Opening-Up in the Medical Field” (hereinafter referred to as…).“Notice on the Pilot Program for Opening Up in the Healthcare Sector”), it is planned to launch two pilot programs to further open up the healthcare sector.

April 11, 2025On [date], the Ministry of Commerce released the “Work Plan for Accelerating the Comprehensive Pilot Program on Expanding Opening-Up in the Service Sector,” which proposes enhancing the level of opening-up and service provision in the healthcare and wellness sectors. It allows non-profit medical institutions to be established through joint donations from Chinese and foreign entities in accordance with relevant regulations, and permits foreign investors to establish non-profit elderly care institutions via donations.

This article will analyze the foreign investment access situation for medical institutions and cell and gene therapy. This is Part 1, focusing on foreign investment access for medical institutions; Part 2 will analyze foreign investment access for cell and gene therapy.

This article analyzes the foreign investment access conditions for medical institutions and cell‑and‑gene‑therapy enterprises. This is the first part, focusing on foreign investment access in the medical institution sector; the second part will examine foreign investment access in the cell‑and‑gene‑therapy sector.

I.Foreign Investment Access for Medical Institutions

(A) General Foreign Investment Restrictions

1. General Foreign Investment (Excluding Service Providers from Hong Kong, Macao, and Taiwan)

Apart from the stipulation that "medical institutions are limited to joint ventures," the Negative List does not further specify equity ratio requirements for Sino-foreign joint ventures. According to the Interim Measures for the Administration of Sino-foreign Equity and Cooperative Medical Institutions, the equity share or interests held by the Chinese party in a Sino-foreign equity joint venture medical institution shall not be less than 30%. The Notice of the Ministry of Health on Adjusting the Approval Authority for Sino-foreign Equity and Cooperative Medical Institutions delegates the approval authority for the establishment, alteration, and termination of Sino-foreign equity joint venture medical institutions to provincial-level health administrative departments. Therefore, provincial health administrative departments can determine approval requirements, including equity ratios, at their discretion based on the regulatory environment within their province. Currently, most regions require the Chinese party to hold no less than 30% equity; however, some regions have made breakthroughs, for example, in Sichuan Province, the Chinese party's equity ratio only needs to be no less than 10%.

Foreign investment access to medical institutions

(I) General Restrictions on Foreign Investment

1, generally foreign investment (excluding service providers from Hong Kong, Macao, and Taiwan)

Except for “medical institutions are limited to joint ventures”Furthermore, the Negative List does not specify any requirements regarding the equity ratio in Sino-foreign joint ventures. According to the Interim Measures for the Administration of Sino-Foreign Joint Venture and Cooperative Medical Institutions, the equity interest or rights held by the Chinese party in a Sino-foreign joint venture medical institution shall not be less than30%。

The “Notice of the Ministry of Health on Adjusting the Approval Authority for Sino-Foreign Joint Venture and Cooperative Medical Institutions” stipulates that the approval authority for the establishment, alteration, and termination of Sino‑foreign joint venture medical institutions is delegated to the provincial-level health administrative departments. Accordingly, each provincial-level health administrative department may, based on the regulatory environment within its province, determine the approval requirements, including shareholding ratios, as appropriate.

Currently, most regions require that the Chinese party’s shareholding must not be less than30%However, some regions have made exceptions to this rule; for example, in Sichuan Province, the Chinese party’s shareholding ratio need only be no less than10%That's all.

2. Service Providers from Hong Kong, Macao, and Taiwan

(1) Service Providers from Hong Kong and Macao

According to Supplementary Provision II to the <Interim Measures for the Administration of Sino-foreign Equity and Cooperative Medical Institutions>, service providers from Hong Kong and Macao may establish clinics solely in the form of wholly-owned enterprises in Guangdong Province. There are no restrictions on the total investment amount or the investment ratio between parties for clinics established in Guangdong Province through joint ventures or cooperation between Hong Kong/Macao service providers and mainland partners. The Interim Measures for the Administration of Wholly Foreign-owned Hospitals Established in Mainland China by Service Providers from Hong Kong and Macao stipulate that service providers from Hong Kong and Macao may, upon approval by the competent mainland authorities in accordance with the law, establish wholly-owned hospitals in mainland China. The establishment of wholly-owned hospitals by Hong Kong and Macao service providers in mainland China is limited to Shanghai, Fujian, Guangdong, Hainan, and Chongqing. The Notice on Expanding the Geographical Scope for Service Providers from Hong Kong and Macao to Establish Wholly Foreign-owned Hospitals in Mainland China stipulates that from April 1, 2012, the geographical scope for service providers from Hong Kong and Macao to establish wholly-owned hospitals in mainland China was expanded from Shanghai, Chongqing, Guangdong, Fujian, and Hainan to all municipalities directly under the Central Government and provincial capital cities.

(2) Service Providers from Taiwan

According to the Interim Measures for the Administration of Wholly Foreign-owned Hospitals Established in Mainland China by Service Providers from Taiwan, service providers from Taiwan may, upon approval by the competent mainland authorities in accordance with the law, establish wholly-owned hospitals in mainland China. The establishment of wholly-owned hospitals by Taiwanese service providers in mainland China is limited to Shanghai, Jiangsu, Fujian, Guangdong, and Hainan.

The author has also noted the recent case of BenQ Medical Center Group Co., Ltd. (hereinafter referred to as "BenQ Medical"), which is applying for a Hong Kong listing. Registered in the Cayman Islands, it indirectly controls 100% equity of Nanjing BenQ Hospital and Suzhou BenQ Hospital. Its Chinese legal counsel believes that BenQ Medical is ultimately owned by Taiwanese investor Qisda Corporation in accordance with the Interim Measures for the Recognition of Taiwanese Investors Investing via a Third Territory (hereinafter referred to as the "Indirect Investment Measures"); according to the Indirect Investment Measures, BenQ Medical is deemed a Taiwanese investor.

2, Hong Kong, Macao, and Taiwan service providers

(1) Hong Kong and Macao service providers

According to the<Provisional Measures for the Administration of Sino-Foreign Joint Venture and Cooperative Medical Institutions>According to the Provisions of Supplementary Regulation No. 2, service providers from Hong Kong and Macao may establish outpatient clinics in Guangdong Province as wholly foreign-owned enterprises; there are no restrictions on the total investment amount for outpatient clinics established in Guangdong Province through joint ventures or cooperative arrangements between service providers from Hong Kong and Macao and mainland entities, nor are there any restrictions on the respective investment proportions of the parties involved.

The Provisional Measures for the Establishment of Wholly Foreign-Owned Hospitals in the Mainland by Hong Kong and Macao Service Providers stipulate that, upon approval by the competent authorities of the mainland in accordance with the law, service providers from Hong Kong and Macao may establish wholly foreign-owned hospitals in the mainland. Hong Kong and Macao service providers are permitted to establish wholly foreign-owned hospitals in mainland China only in Shanghai, Fujian Province, Guangdong Province, Hainan Province, and Chongqing Municipality.

The “Notice on Expanding the Geographic Scope for Hong Kong and Macao Service Providers to Establish Wholly Foreign-Owned Hospitals in Mainland China” stipulates that, effective April 1, 2012,…Effective immediately, the geographical scope for Hong Kong and Macao service providers to establish wholly foreign-owned hospitals in mainland China has been expanded from Shanghai, Chongqing, Guangdong Province, Fujian Province, and Hainan Province to include all municipalities directly under the central government and provincial capital cities.

(2) Taiwan service provider

According to the Provisional Measures for the Administration of Wholly Foreign-Owned Hospitals Established in Mainland China by Taiwan Service Providers, Taiwan service providers may, upon approval by the competent authorities in Mainland China in accordance with the law, establish wholly foreign-owned hospitals in Mainland China. Taiwanese service providers are permitted to establish wholly foreign-owned hospitals only in Shanghai, Jiangsu Province, Fujian Province, Guangdong Province, and Hainan Province on the mainland.

The author has also noted that BenQ Medical Group Co., Ltd. (hereinafter referred to as…), which is currently applying for a Hong Kong stock listing,…"BenQ Medical Center"), which is registered in the Cayman Islands and indirectly controls Nanjing Mingchi Hospital and Suzhou Mingchi Hospital.100%the equity. Its Chinese legal counsel believes that Mingchi Hospital was established by the Taiwanese investor Compal Electronics, Inc., in accordance with the “Provisional Measures for the Recognition of Investments Made by Taiwanese Investors Through a Third Jurisdiction” (hereinafter referred to as…"The Transfer Procedures") Ultimate ownership; pursuant to the “Measures for Cross-Strait Investment,” Mingchi Hospital is regarded as a Taiwanese investor.

(B) Opening Pilot Initiatives

1. National Level

The Medical Field Opening Pilot Notice issued in September 2024 allows the establishment of wholly foreign-owned hospitals (excluding TCM hospitals, and excluding acquisitions of public hospitals) in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and the entire island of Hainan.

The Notice on Carrying Out Pilot Work for the Establishment of Wholly Foreign-owned Hospitals, jointly issued by the former National Health and Family Planning Commission (NHFPC) and MOFCOM in July 2014 and still effective, explicitly allowed overseas investors to establish wholly foreign-owned hospitals through new establishment or acquisition in Beijing, Tianjin, Shanghai, Jiangsu, Fujian, Guangdong, and Hainan. In November 2024, the Notice on Issuing the Work Plan for Expanding the Pilot Program for Wholly Foreign-owned Hospitals (hereinafter referred to as the "Wholly Foreign-owned Hospital Expansion Pilot Notice") jointly issued by the NHC, MOFCOM, the National Administration of Traditional Chinese Medicine (NATCM), and the National Administration for Disease Control and Prevention (NCA), allows the establishment of wholly foreign-owned hospitals in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and the entire island of Hainan. It is important to note that other types of medical institutions (e.g., nursing homes, medical testing laboratories) are not yet within the scope of the opening pilot work; foreign investment can still only participate through joint ventures with Chinese parties.

The promulgation dates of the Notice on Carrying Out Pilot Work for the Establishment of Wholly Foreign-owned Hospitals and the Wholly Foreign-owned Hospital Expansion Pilot Notice are ten years apart. Let's compare the two regulations from the perspectives of pilot regions, investment methods, categories of medical institutions, and investor qualification requirements, as detailed below:

(II) Open pilot programs

1. At the national level

September 2024The “Pilot Notice on Opening Up the Healthcare Sector,” issued in January, permits the establishment of wholly foreign-owned hospitals in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and across the entire Hainan Province (excluding traditional Chinese medicine institutions and excluding mergers and acquisitions involving public hospitals).

The National Health and Family Planning Commission and the Ministry of Commerce in July 2014The “Notice on Launching the Pilot Program for Establishing Wholly Foreign-Owned Hospitals,” which was issued in [month] and remains currently in effect, (hereinafter referred to as…“Notice on the Pilot Program for Wholly Foreign-Owned Hospitals”It explicitly permits foreign investors to establish wholly foreign-owned hospitals in Beijing, Tianjin, Shanghai, Jiangsu Province, Fujian Province, Guangdong Province, and Hainan Province through either new establishment or mergers and acquisitions.

November 2024In [month], the National Health Commission, the Ministry of Commerce, the State Administration of Traditional Chinese Medicine, and the National Disease Prevention and Control Bureau issued the “Notice on Printing and Distributing the Pilot Work Plan for Expanding Opening-Up in the Field of Wholly Foreign-Owned Hospitals” (hereinafter referred to as…).“Notice on Expanding the Pilot Program for Wholly Foreign-Owned Hospitals””) Foreign-invested wholly-owned hospitals are permitted to be established in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and throughout Hainan Island.

It should be noted that other medical institutions outside of hospitals (such as nursing homes and medical testing laboratories) are not yet included in the scope of the pilot program; foreign investment may still only participate through joint ventures with Chinese partners.

The “Pilot Notice on Wholly Foreign-Owned Hospitals” and the “Notice on Expanding the Pilot Program for Wholly Foreign-Owned Hospitals” were issued a decade apart. Let us compare these two regulations in terms of pilot regions, investment modalities, types of medical institutions, and eligibility criteria for investors, as follows:

2. Local Level

On December 3, 2024, the Tianjin Municipal Health Commission and other departments jointly issued the Notice on Implementing the Work Plan for Expanding the Pilot Program for Wholly Foreign-owned Hospitals, requiring health departments to establish collaborative mechanisms with relevant departments to optimize and enhance work efficiency. The district health commissions where wholly foreign-owned hospitals are located should conduct operational assessments together with relevant departments and promptly coordinate to resolve difficulties encountered in the pilot program.

On December 16, 2024, the Guangdong Provincial Health Commission and other departments jointly issued the Work Plan for Expanding the Pilot Program for Wholly Foreign-owned Hospitals in Guangdong Province (Trial), allowing the establishment of wholly foreign-owned hospitals (excluding TCM hospitals, and excluding acquisitions of public hospitals) in Guangzhou and Shenzhen.

Based on current market entity registration rules and medical institution establishment rules, medical institutions, regardless of category, ownership form, affiliation, or service target, must comply with the local Medical Institution Establishment Plan. Local medical institution establishment plans are formulated by health administrative departments of local people's governments at or above the county level. Wholly foreign-owned hospitals involve different ownership forms and investment entities; their establishment first requires unified planning by local regulatory authorities.

2. At the local level

December 3, 2024On [date], the Tianjin Municipal Health Commission and other departments jointly issued the “Notice on Doing a Good Job in the Pilot Program for Expanding Opening-Up in the Field of Wholly Foreign-Owned Hospitals,” stipulating that health authorities shall establish a collaborative working mechanism with relevant departments to optimize and enhance work efficiency. The district health commission where the wholly foreign-owned hospital is located shall, in coordination with relevant departments, conduct operational evaluations and promptly coordinate to resolve any challenges encountered during the pilot program.

December 16, 2024On [date], the Guangdong Provincial Health Commission and other departments jointly issued the “Pilot Work Plan for Expanding Opening-Up in the Field of Wholly Foreign-Owned Hospitals in Guangdong Province (Trial),” which permits the establishment of wholly foreign-owned hospitals in Guangzhou and Shenzhen, excluding traditional Chinese medicine hospitals and transactions involving the acquisition or merger of public hospitals.

Based on the current regulations governing the registration of market entities and the establishment of medical institutions, regardless of their category, ownership structure, affiliation, or target patient population, all medical institutions must comply with the local “Medical Institution Establishment Plan,” which is formulated by the health administrative departments of the people’s governments at or above the county level. Privately owned hospitals with foreign investment involve different forms of ownership and investors, and their establishment must first be subject to unified planning by the local regulatory authorities.

3. Shanghai Pilot Work Plan: Expanding High-Level Opening Up in the Medical Field

On December 26, 2024, the Shanghai Municipal Health Commission and other departments jointly issued the Shanghai Work Plan for Deepening the Expansion of the Pilot Program for Wholly Foreign-owned Hospitals (hereinafter referred to as the "Shanghai Pilot Plan"). This plan allows the establishment of wholly foreign-owned hospitals in Shanghai (excluding TCM hospitals, and excluding acquisitions of public hospitals). It encourages the establishment of such hospitals in areas designated for expanded opening-up pilots such as the Pilot Free Trade Zone, Lingang Special Area, Hongqiao Business District, and Dongfang Hub International Business District, as well as in biopharmaceutical industry clusters and central urban areas with concentrated foreign resident populations. Recently, the Shanghai Municipal Health Commission and seven other departments formulated the Key Points of Work for Deepening the Reform of the Medical and Health System in Shanghai in 2025, which also lists exploring the establishment of wholly foreign-owned medical institutions as a key work point, leveraging national strategic zones like the Pudong New Area Modernization Leading Zone, Hongqiao International Central Business District, and Lingang Special Area of the Pilot Free Trade Zone for pioneering trials.

Overseas investors applying to establish a wholly foreign-owned hospital in Shanghai must be legal persons capable of independently bearing civil liability, possess direct or indirect experience in healthcare investment and management, and meet the following conditions: 1. Be able to provide internationally advanced hospital management concepts, models, and service models; 2. Be able to provide internationally leading medical technology and equipment; 3. Be able to supplement or improve local deficiencies in medical service capacity, medical technology, and medical facilities, and expand the diversified service supply landscape. The Shanghai Pilot Plan allows wholly foreign-owned hospitals to hire foreign physicians, physicians from Hong Kong, Macao, and Taiwan, and other health professionals from Hong Kong and Macao for short-term practice according to regulations, but the proportion of Chinese (mainland) personnel in both hospital management and health professional technical positions must not be less than 50% respectively.

The operational nature of a wholly foreign-owned hospital can be for-profit or non-profit. However, the following points require attention during establishment: 1. It shall not establish psychiatric hospitals, infectious disease hospitals, hematology hospitals, TCM hospitals, integrated TCM and Western medicine hospitals, or ethnic minority medicine hospitals; 2. The hospital's clinical departments shall not register Hematology; 3. The hospital shall not carry out medical treatments and diagnostics with high medical and ethical risks, mainly including human organ transplantation technology, human assisted reproductive technology, prenatal screening and prenatal diagnosis technology, inpatient psychiatric treatment, experimental treatment of new tumor cell therapy technologies, etc.; 4. The hospital information management system shall be connected to the municipal and district medical service supervision platforms; servers storing electronic medical records, medical equipment information, etc., shall be located within the territory of China. Therefore, wholly foreign-owned hospitals must pay high attention in their daily operations to requirements concerning human genetic resources, health and medical data, and high-risk medical technologies to ensure compliant operation.

Following the promulgation of the Medical Field Opening Pilot Notice in September 2024, three wholly foreign-owned hospitals have been established in Tianjin, Guangzhou, and Shanghai:

On December 16, 2024, Tianjin Municipality issued the first Practice License for a wholly foreign-owned tertiary general hospital, officially confirming Pengrui Li General Hospital (Tianjin Pengrui Li Hospital) as China's first wholly foreign-owned tertiary general hospital.

On January 2, 2025, Guangzhou Baiyun Pengrui Li Hospital was approved by the Guangdong Provincial Health Commission to settle in Guangzhou, becoming the first newly established wholly foreign-owned hospital in Guangdong after the Medical Field Opening Pilot Notice was issued.

On March 14, 2025, Shanghai DeltaHealth Hospital officially obtained the Medical Institution Practice License issued by the Shanghai Municipal Health Commission, becoming the nation's first wholly foreign-owned cardiovascular specialty hospital.

Additionally, on April 14, 2025, the 2025 Hainan Free Trade Port Global Industrial Investment Promotion Conference was held in Haikou, Hainan. Sanya plans to introduce Singapore's Pengrui Li Group to establish Hainan Free Trade Port's first wholly foreign-owned hospital project.

3、Shanghai Pilot Work Plan,Expand high-level opening-up in the healthcare sector.

December 26, 2024On [date], the Shanghai Municipal Health Commission and other departments jointly issued the “Shanghai Plan for Deepening Pilot Programs to Further Open Up the Sector of Wholly Foreign-Owned Hospitals.”(hereinafter referred to as the Pilot Program)Foreign-invested wholly-owned hospitals are permitted to be established in Shanghai (excluding traditional Chinese medicine hospitals and excluding mergers and acquisitions of public hospitals).

Encourage the establishment of wholly foreign-owned hospitals in pilot zones for broader opening-up, such as the free trade pilot zone, the Lingang New Area, the Hongqiao Business District, and the Eastern Hub International Business District, as well as in areas with a high concentration of biomedical industries and in central urban districts where expatriates are densely concentrated. Recently,The Shanghai Municipal Health Commission and seven other departments have formulated the “...”.2025Key Tasks for Deepening the Reform of the Medical and Healthcare System in Shanghai in [Year], also putsLeveraging national strategic platforms such as the Pudong New Area as a leading zone for modernization, the Hongqiao International Central Business District, and the Lingang New Area of the Free Trade Zone, we will take the lead in piloting the establishment of wholly foreign-owned medical institutions.Included in the key work priorities.

Foreign investors applying to establish a wholly foreign-owned hospital shall be legal entities capable of independently assuming civil liability, possess direct or indirect experience in investing in and managing healthcare services, and shall comply with1、Capable of providing internationally advanced hospital management.Concepts, management models, and service models;2、It is capable of providing medical technologies and equipment that are at an internationally leading level.3、It can address or improve local deficiencies in healthcare service capacity, medical technology, and medical facilities, thereby expanding a diversified service supply landscape.

The pilot program allows wholly foreign-owned enterprises.The hospital, in accordance with regulations, employs foreign physicians, physicians from Hong Kong, Macao, and Taiwan, as well as other healthcare professionals from Hong Kong and Macao, for short-term practice.ButThe proportion of Chinese (mainland) personnel among all management and health professional and technical staff in the hospital shall not be less than50%。

The operating nature of wholly foreign-owned hospitals may be either for-profit or non-profit.However, during the establishment process, it is important to note the following: 1.The establishment of psychiatric hospitals, infectious disease hospitals, hematology hospitals, traditional Chinese medicine hospitals, hospitals integrating traditional Chinese and Western medicine, and hospitals specializing in ethnic minority medicine is prohibited.2、The hospital shall not register hematology as a clinical specialty.3Hospitals shall not conduct medical procedures or diagnostic and therapeutic activities that carry high medical and ethical risks, including but not limited to human organ transplantation, assisted reproductive technologies, prenatal screening and prenatal diagnostic techniques, inpatient psychiatric treatment, and experimental treatments using novel tumor cell therapies.；4、Hospital information management systems shall be connected to the municipal and district medical service supervision platforms, and the information storage servers for electronic health records, medical equipment, and other data shall be located within the territory of China.。

Therefore, wholly foreign-owned hospitals should, in their day-to-day operations, pay close attention to requirements related to human genetic resources, health‑care data, and high‑risk medical technologies, ensuring compliance with applicable regulations.

(III) Establishment of wholly foreign-owned hospitals

September 2024Following the issuance of the “Notice on Pilot Programs for Opening Up the Healthcare Sector” in January, three wholly foreign-owned hospitals have now been established in Tianjin, Guangzhou, and Shanghai, respectively.

December 16, 2024On [date], Tianjin City issued the first license to operate a wholly foreign-owned tertiary general hospital, officially recognizing Prenetics General Hospital (Tianjin Prenetics Hospital) as the country’s first wholly foreign-owned tertiary general hospital.

January 2, 2025On [date], Guangzhou Baiyun Pengruili Hospital was approved by the Guangdong Provincial Health Commission to establish itself in Guangzhou, becoming the first newly established wholly foreign-owned hospital in Guangdong following the issuance of the “Notice on Pilot Programs for Opening Up the Healthcare Sector.”

March 14, 2025On that day, Shanghai Deda Hospital officially obtained the medical institution practice license issued by the Shanghai Municipal Health Commission, becoming the first wholly foreign-owned cardiovascular Junior College hospital in the country.

In addition, on April 14, 2025, 2025The 2023 Hainan Free Trade Port Global Investment Promotion Conference was held in Haikou, Hainan. Sanya plans to partner with Singapore’s Parkway Group to establish the first wholly foreign-owned hospital project in the Hainan Free Trade Port.

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