广州市外商独资医院设置审批和执业登记工作指引(英文版)

　　Notice of the Guangzhou Municipal Health Commission on Issuing the Work Guide of Guangzhou Municipality for the Establishment Approval and Practice Registration of Wholly Foreign-Owned Hospitals (Trial Implementation)

　　To all district health bureaus and relevant units:

　　In accordance with the Notice on Issuing the Guangdong Province Work Plan for the Pilot Program to Expand Opening-Up in the Wholly Foreign-Owned Hospital Sector (Trial Implementation) jointly issued by the Health Commission of Guangdong Province, the Department of Commerce of Guangdong Province, the Traditional Chinese Medicine Bureau of Guangdong Province, and the Guangdong Provincial Center for Disease Control and Prevention, this Commission has formulated the Work Guide of Guangzhou Municipality for the Establishment Approval and Practice Registration of Wholly Foreign-Owned Hospitals (Trial Implementation). The Guide is hereby issued for your implementation. Please ensure strict compliance in light of local conditions.

　　Guangzhou Municipal Health Commission

　　                                                                      January 9, 2025

　　(For enquiries, please contact: Zhu Rong, Tel: 020-81077837)

Work Guide of Guangzhou Municipality for the Establishment Approval and Practice Registration of Wholly Foreign-Owned Hospitals (Trial Implementation)

　　In accordance with the Notice on Issuing the Guangdong Province Work Plan for the Pilot Program to Expand Opening-Up in the Wholly Foreign-Owned Hospital Sector (Trial Implementation) jointly issued by the Health Commission of Guangdong Province, the Department of Commerce of Guangdong Province, the Traditional Chinese Medicine Bureau of Guangdong Province, and the Guangdong Provincial Center for Disease Control and Prevention, and in order to provide policy guidance and facilitate the standardized establishment of wholly foreign-owned medical institutions in Guangzhou, this Guide is formulated based on actual conditions and is hereby issued as follows.

　　I Application Requirements

　　A. Investment Entity

　　The foreign investor shall be a legal person capable of independently bearing civil liability, with direct or indirect experience in healthcare investment and management, and shall meet at least one of the following requirements:

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

　　2. Ability to introduce internationally advanced medical technologies and equipment.

　　3. Ability to complement or enhance Guangzhou’s medical service capacity, technologies, and facilities, thereby promoting a diversified medical service system.

　　B. Hospital Category and Level

　　Hospitals shall be limited to the following categories: General Hospitals, Specialized Hospitals, and Rehabilitation Hospitals. The establishment of Psychiatric Hospitals, Infectious Disease Hospitals, Hematology Hospitals, Traditional Chinese Medicine Hospitals, Integrated Traditional Chinese and Western Medicine Hospitals, and Ethnic Medicine Hospitals is not permitted. Hospitals shall be classified at the tertiary level.

　　C. Operational Nature

　　Hospitals may be established as either for-profit or non-profit institutions.

　　D. Scope of Medical Practice

　　The following are prohibited:

　　1. Establishment or registration of a Hematology Department;

　　2. Engagement in medical activities involving high clinical or ethical risks, including but not limited to human organ transplantation, assisted reproductive technologies, prenatal screening and diagnosis, inpatient psychiatric treatment, and experimental therapies involving novel tumor cell technologies.

　　II Approval Procedures

　　A. Standard Approval Process for For-Profit Wholly Foreign-Owned Hospitals

　　Step 1: The Guangzhou Municipal Market Regulatory Administration conducts enterprise registration and issues the Business License.

　　Step 2: Upon acceptance and completion of a preliminary review of the application for the Medical Institution Practice License (covering both Establishment Approval and Practice Registration), the Guangzhou Municipal Health Commission submits the application to the provincial health commission. Prior to formal approval, the municipal health commission provides market access policy consultation services.

　　The following reviews shall be conducted in parallel and are not prerequisites for one another:

　　Fire safety design review by the Guangzhou Municipal Housing and Urban–Rural Development Bureau;

　　Environmental Impact Assessment (EIA) approval by the Guangzhou Municipal Ecological Environment Bureau;

　　Energy conservation review by the Guangzhou Municipal Development and Reform Commission.

　　For projects involving land use and construction, the Guangzhou Municipal Planning and Natural Resources Bureau shall handle relevant procedures, including issuance of site selection opinions, land supply coordination, and approval of the Land Use Planning Permit and Construction Project Planning Permit.

　　Step3: The Health Commission of Guangdong Province conducts the final review of the application for Establishment Approval and Practice Registration of the Medical Institution Practice License.

　　Step4: Based on the provincial review decision, the Guangzhou Municipal Health Commission issues either the Approval Certificate for the Establishment of a Medical Institution or the Medical Institution Practice License.

　　B. Standard Approval Process for Non-Profit Wholly Foreign-Owned Hospitals

　　Step1: The Guangzhou Municipal Civil Affairs Bureau registers the hospital as a private non-enterprise unit and issues the Registration Certificate of Private Non-enterprise Units.

　　Step 2: Upon accepting and completing a preliminary review of the application for the hospital's Establishment Approval and Practice Registration for the Medical Institution Practice License, the Guangzhou Municipal Health Commission submits it to the provincial health commission. Prior to the Establishment Approval and Practice Registration, the municipal health commission provides Market Access Policy Consultation.

　　The following reviews are conducted in parallel with the hospital’s Establishment Approval and Practice Registration and are not prerequisites for one another:

　　The Guangzhou Municipal Housing and Urban-rural Development Bureau conducts the fire safety design review for the medical construction projects as required by law.

　　The Guangzhou Municipal Ecological Environment Bureau conducts the environmental impact assessment (EIA) approval for the hospital as required by law.

　　The Guangzhou Municipal Development and Reform Commission conducts the energy conservation review for the hospital as required by law.

　　For projects involving land use and construction, the Guangzhou Municipal Planning and Natural Resources Bureau is responsible for handling the relevant procedures, including issuing the pre-approval review and site selection opinion letter for hospital land use, facilitating land supply, and granting the Land Use Planning Permit and Construction Project Planning Permit.

　　Step 3: The Health Commission of Guangdong Province conducts the review of the application for the hospital's Establishment Approval and Practice Registration for the Medical Institution Practice License for the wholly foreign-owned hospitals.

　　Step 4: Based on the review decision of the Health Commission of Guangdong Province, the Guangzhou Municipal Health Commission shall issue either the Approval Certificate for the Establishment of a Medical Institution or the Medical Institution Practice License.

　　C. Approval Authority and Division of Responsibilities

　　The approval authority for wholly foreign-owned hospitals, including Establishment Approval and Practice Registration, rests with the Health Commission of Guangdong Province. In accordance with relevant provincial regulations, the Guangzhou Municipal Health Commission is responsible for organizing and implementing the administrative processing of applications within the municipality.

　　Applicants shall submit applications through the Guangdong Government Service Online Portal (https://www.gdzwfw.gov.cn/). Upon preliminary approval, applications are forwarded to the provincial health commission for final review. Following approval, this Commission issues the relevant certificates.

　　III. Application Documents

　　Detailed service guidelines are available on the Guangdong Government Service Online Portal. (https://www.gdzwfw.gov.cn/ ).

　　A.Documents Required for Establishment Approval

　　1.Application Letter for Establishment of a Medical Institution;

　　2.Feasibility Study Report;

　　3.Site Selection Report;

　　4.Business License or Legal Person Registration Certificate;

　　5.Identification documents of the legal representative;

　　6.Project proposal signed by the legal representative;

　　7.Bank Credit Certificate or proof of funds demonstrating compliance with minimum investment requirements;

　　8.Other required documents (if applicable), including a Power of Attorney and identification of the authorized agent.

　　Copies may be submitted unless originals are specifically required. Originals must be presented for verification.

　　B. Documents Required for Practice Registration

　　1.Application Form for Medical Institution Practice Registration;

　　2.Approval Certificate for Establishment of a Medical Institution;

　　3.Legal person qualification documents (original and copies);

　　4.Property ownership or usage certificates;

　　5.Architectural floor plans;

　　6.Articles of association and internal rules and regulations;

　　7.Qualification certificates and practicing certificates of the legal representative or chief executive;

　　8.Roster and qualification documents of department heads;

　　9.Summary table of clinical departments and staffing;

　　10.Commitment letter signed by the legal representative affirming the authenticity of submitted materials.

　　IV Acceptance and Approval Conditions

　　A.Conditions for Acceptance of Establishment Approval Applications

　　1.Application materials are complete and in statutory form;

　　2.Submitted content complies with regulatory requirements.

　　B.Circumstances for Non-Approval of Establishment Applications

　　Approval shall not be granted under circumstances including, but not limited to:

　　1.Failure to meet applicant qualifications;

　　2.Insufficient investment funds;

　　3.Unreasonable site selection;

　　4.Non-compliance with Basic Standards for Medical Institutions;

　　5.False or misleading application materials;

　　6.Verified objections raised during the public notice period.

　　C. Conditions for Approval of Practice Registration

　　1.Application materials are complete and compliant;

　　2.Submitted content meets regulatory requirements.

　　D. Circumstances for Non-Approval of Practice Registration

　　Including but not limited to:

　　1.Deviation from the approved scope or content of establishment;

　　2.Failure to meet the basic standards for Medical Institutions;

　　3.Inadequate registered capital investment;

　　4.Inadequate premises, facilities, or equipment;

　　5.Non-compliant articles of association or internal management rules and regulations;

　　6.Failure of on-site inspections or assessments;

　　7.Mainland Chinese personnel accounting for less than 50% of management personnel and healthcare professionals;

　　8.Failure to obtain necessary approvals from relevant government departments;

　　9.Other violations of applicable laws, regulations, and health administration rules.

　　V Miscellaneous Provisions

　　This Guide shall take effect upon issuance. In the event of any inconsistency with subsequently issued national or provincial normative documents, such documents shall prevail. Issues encountered during implementation and related suggestions shall be reported promptly to the Guangzhou Municipal Health Commission.

　　Appendices:

　　1.Flowchart for Establishment Approval of Wholly Foreign-Owned Hospitals

　　2.Flowchart for Practice Registration of Wholly Foreign-Owned Hospitals

　　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）》