广州市外商独资医院政策“一问一答”（英文版）

　　Guangzhou Policy on Wholly Foreign-Owned Hospitals: Questions & Answers

　　Question 1: What are the requirements for the investment entity of a wholly foreign-owned hospital in Guangzhou?

　　Answer:
Foreign investors applying to establish a wholly foreign-owned hospital must be legal entities capable of independently bearing civil liability, with direct or indirect experience in healthcare investment and management, and must meet the following requirements:

　　1. Ability to provide internationally advanced hospital management concepts, management models, and service models;

　　2. Ability to provide medical technologies and equipment at an internationally leading level;

　　3. Ability to supplement or improve deficiencies in Guangzhou’s medical service capacity, medical technologies, and medical facilities, and to expand a diversified service supply structure.

　　Question 2: What hospital grade is required for wholly foreign-owned hospitals established in Guangzhou?

　　Answer:
Wholly foreign-owned hospitals established in Guangzhou must be Grade III (tertiary) hospitals.

　　Question 3: What categories of wholly foreign-owned hospitals are permitted in Guangzhou?

　　Answer:
Permitted categories include general hospitals, specialized hospitals, and rehabilitation hospitals.
The establishment of psychiatric hospitals, infectious disease hospitals, hematology hospitals, traditional Chinese medicine (TCM) hospitals, integrated Chinese-Western medicine hospitals, and ethnic minority medicine hospitals is not permitted.

　　Question 4: What are the requirements regarding the operational nature of wholly foreign-owned hospitals in Guangzhou?

　　Answer:
Wholly foreign-owned hospitals established in Guangzhou may be either for-profit or non-profit.

　　Question 5: What are the requirements regarding the scope of medical practice for wholly foreign-owned hospitals in Guangzhou?

　　Answer:
Wholly foreign-owned hospitals may not register hematology (internal medicine) as a clinical department, nor may they conduct medical activities with relatively high medical or ethical risks. These mainly include:

　　· Human organ transplantation technologies;

　　· Human assisted reproductive technologies;

　　· Prenatal screening and prenatal diagnostic technologies;

　　· Inpatient psychiatric treatment;

　　· Experimental treatments involving new tumor cell therapy technologies.

　　Question 6: What are the establishment and operational requirements for the scope of medical practice of wholly foreign-owned hospitals?

　　Answer:
Wholly foreign-owned hospitals must be established and operated in accordance with laws and regulations such as the Basic Medical and Health Care and Health Promotion Law of the People’s Republic of China, the Biosecurity Law of the People’s Republic of China, the Data Security Law of the People’s Republic of China, the Regulations on the Administration of Medical Institutions, and the Regulations on the Administration of Human Genetic Resources of the People’s Republic of China. They must conduct medical activities in accordance with the law and strengthen internal management.

　　1. If established as a for-profit medical institution, registration shall be completed with the local market supervision and administration bureau in Guangzhou to obtain a Business License; if established as a non-profit medical institution, registration shall be completed with the local civil affairs bureau in Guangzhou to obtain a Registration Certificate for Private Non-Enterprise Units.

　　2. Proposed wholly foreign-owned hospitals must meet the basic standards for medical institutions formulated by the state and province. Overseas investors are encouraged to establish high-end and specialized wholly foreign-owned hospitals in Guangzhou, achieving differentiated development from other local medical institutions.

　　3. Hospitals are permitted to employ foreign physicians, physicians from Hong Kong, Macao, and Taiwan, and other healthcare professionals from Hong Kong and Macao for short-term practice as stipulated. The proportion of Chinese (mainland) personnel among hospital management staff and healthcare professionals must not be less than 50%.

　　4. Hospitals must be equipped with information systems compatible with their functions and must connect to the medical service regulatory platform of the Guangzhou Municipal Health Commission as required. Servers storing electronic medical records, medical equipment data, and related information must be located within China.

　　5. Medical record management must comply with the Provisions on the Administration of Medical Records in Medical Institutions (2013 Edition) and the Administrative Specifications for the Application of Electronic Medical Records (Trial), among other regulations.

　　6. Hospitals must comply with national laws, regulations, and rules, including clinical practice guidelines and technical standards, medical technology access, infectious disease prevention and control, biosecurity management, and medical ethics. They must strengthen medical quality management and ensure medical safety; comply with national and provincial regulations on medical service items and pricing; and standardize medical charging practices. Hospitals meeting relevant requirements may apply to be included as designated medical insurance providers in accordance with procedures.

　　Question 7: What are the specific steps in the approval process for wholly foreign-owned hospitals?

　　Answer:
The approval process includes the following steps:

　　1. Registration of the investment entity: For-profit wholly foreign-owned hospitals are registered with the Guangzhou Municipal Market Supervision Bureau and issued a Business License; non-profit wholly foreign-owned hospitals are registered with the Guangzhou Municipal Civil Affairs Bureau and issued a Registration Certificate for Private Non-Enterprise Units.

　　2. Preliminary review and submission: The Guangzhou Municipal Health Commission conducts the preliminary review of the medical practice license application and submits it to the Guangdong Provincial Health Commission. During this period, the Municipal Health Commission provides policy consultation on market entry, while departments of housing and urban-rural development, ecological environment, and development and reform conduct fire protection design review for construction projects, environmental impact assessment approval, and energy-saving review, respectively; the planning and natural resources department handles land-use related procedures.

　　3. Provincial review: The Guangdong Provincial Health Commission reviews the medical practice license application to ensure that the establishment and practice of the hospital comply with relevant policies, regulations, and standards, and issues review opinions.

　　4. Issuance of approval documents or practice license: Based on the review opinions of the provincial health authority, the Guangzhou Municipal Health Commission issues either the Approval Certificate for the Establishment of a Medical Institution or the Medical Institution Practice License.

　　Question 8: What materials are required for establishment approval of a wholly foreign-owned hospital?

　　Answer:
The following materials are required:

　　1. Application for establishment of a medical institution;

　　2. Feasibility study report;

　　3. Site selection report;

　　4. Registration certificate of the wholly foreign-owned enterprise as a legal entity;

　　5. Identification of the legal representative;

　　6. Project proposal signed by the legal representative;

　　7. Creditworthiness certificate;

　　8. Other materials, such as a Power of Attorney and a copy of the agent’s identification if the application is handled by an authorized person. Copies of application materials must be verified against the originals.

　　Question 9: What materials are required for practice registration of a wholly foreign-owned hospital?

　　Answer:
The following materials must be submitted:

　　1. Application Form for Practice Registration of a Medical Institution;

　　2. Approval Certificate for the Establishment of a Medical Institution;

　　3. Original and duplicate copies of the medical institution’s legal entity qualification certificate;

　　4. Proof of ownership or right to use the medical premises;

　　5. Architectural layout drawings of the medical institution;

　　6. Rules and regulations of the medical institution;

　　7. Copies of qualification certificates and practice certificates of the legal representative or principal person in charge;

　　8. List of department heads and copies of their qualification and practice certificates;

　　9. Summary table of clinical departments, proposed staff, practice qualification information, and professional titles;

　　10. Letter of commitment signed by the legal representative confirming the authenticity of the application materials.

　　Question 10: Under what circumstances will establishment approval or practice registration be denied for a wholly foreign-owned hospital?

　　Answer: 
Circumstances for Denial of Establishment Approval:

　　Establishment approval will be denied if any of the following circumstances exist:

　　1. The applicant (entity) does not meet the prescribed conditions;

　　2. The investor cannot provide creditworthiness certificates sufficient to cover the total investment amount;

　　3. The proposed site selection is unreasonable;

　　4. The basic standards for medical institutions are not met;

　　5. The submitted application materials or stated circumstances are untrue;

　　6. During the public announcement period of establishment approval, reports or public objections are received and, after investigation by health authorities, are found to be valid.

　　     Circumstances for Denial of Practice Registration:

　　Practice registration will be denied if any of the following circumstances exist:

　　1. The application does not comply with the items approved in the Approval Certificate for the Establishment of a Medical Institution;

　　2. The Basic Standards for Medical Institutions are not met;

　　3. Investment funds are not in place;

　　4. The medical premises cannot meet the functional requirements for diagnosis and treatment services;

　　5. Public facilities such as communications, power supply, water supply, and drainage cannot ensure normal operation;

　　6. Institutional rules and regulations do not meet requirements;

　　7. On-site spot checks of basic knowledge and skills related to disinfection, isolation, and aseptic operations are unqualified;

　　8. The proportion of Chinese (mainland) personnel among hospital management staff and healthcare professionals is less than 50%.

　　Relevant Documents: 《广州市外商独资医院设置审批和执业登记工作指引（试行）》