Administrative Regulations on Medical Institutions (Revised in 2016)

Order of the State Council of the People's Republic of China No.666

February 6, 2016

(Promulgated by the order of the State Council of the People's Republic of China No.149 on February 26, 1994; and revised in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on February 6, 2016)

Chapter I General Provisions

Article 1 The Administrative Regulations on Medical Institutions (hereinafter referred to as the "Regulations") are hereby formulated in order to strengthen the administration over medical institutions, promote the development of medical and health undertakings and protect the health of citizens.

Article 2 The Regulations apply to medical institutions such as hospitals, health centers, sanatoriums, out-patient departments, clinics and health posts (rooms) as well as first-aid stations engaging in disease diagnosis and treatment activities.

Article 3 Medical institutions aim to heal the wounded and rescue the dying, prevent and cure diseases and provide services for health of citizens.

Article 4 The State supports the development of medical institutions and encourages setting up medical institutions in various forms.

Article 5 The health administrative department under the State Council is responsible for the supervision and administration over medical institutions nationwide.
Health administrative departments of local people's governments at the county level or above are responsible for the supervision and administration over medical institutions within their respective administrative regions.
The competent health department of the Chinese People's Liberation Army shall, in accordance with the relevant provisions of the Regulations and the State, carry out supervision and administration over military medical institutions.

Chapter II Planning, Layout and Examination and Approval of the Setup

Article 6 The health administrative department of a local people's government at the county level or above shall, according to the population, medical resources, medical needs and the distribution of existing medical institutions within its administrative region, develop a plan for setting up medical institutions within its administrative region.
Governmental agencies, enterprises and public institutions may set up medical institutions according to their needs, and such medical institutions shall be included into the local plan for setting up medical institutions.

Article 7 Local people's governments at the county level or above shall include the plan for setting up medical institutions into the local regional health development plan and the overall planning for urban and rural construction and development.

Article 8 The setup of medical institutions shall comply with the plan for setting up medical institutions and the basic standards for medical institutions.
The basic standards for medical institutions shall be prepared by the health administrative department under the State Council.

Article 9 Where an entity or individual sets up a medical institution, the entity or individual must go through the examination and approval procedures with the health administrative department of the local people's government at the county level or above, and may handle other formalities with the relevant departments only after obtaining the approval letter on the setup of a medical institution.


Article 10 To apply for setting up a medical institution, the following documents shall be submitted:
1. the application for the setup;
2. the feasibility study report on the setup; and
3. the report on site selection and the architectural design plan.

Article 11 An entity or individual setting up a medical institution shall submit an application for the setup in accordance with the following provisions:
1. for medical institutions with no bed or with less than 100 beds, the entity or individual shall apply to the health administrative department of the people's government at the county level in the place where the medical institution is located; and
2. for medical institutions and special hospitals with 100 beds or more, the entity or individual shall make an application in accordance with the provisions of the health administrative department of the people's government at the provincial level.

Article 12 Health administrative departments of local people's governments at the county level or above shall, within 30 days upon the acceptance of the application for the setup, give a written reply of approval or refusal; where the application is approved, an approval letter on the setup of a medical institution shall be granted.

Article 13 The setup of medical institutions uniformly planned by the State shall be decided by the health administrative department under the State Council.

Article 14 Where governmental agencies, enterprises and public institutions set up out-patient departments, clinics, and health posts (rooms) to provide services for their employees in accordance with the basic national standards for medical institutions, they shall file the setup for record with the health administrative departments of the people's governments at the county level in the places where the medical institutions are located.

Chapter III Registration

Article 15 Medical institutions must be registered for practice, and obtain the License for Practicing of Medical Institutions.

Article 16 To apply for practice registration of medical institutions, a medical institution shall meet the following conditions:
1. having the approval letter on the setup of a medical institution;
2. complying with the basic standards for medical institutions;
3. having a suitable name, organization and premise;
4. having funds, facilities, equipment and professional medical workers corresponding to the business it will engage in;
5. having the corresponding rules and regulations; and
6. being able to bear civil liabilities independently.

Article 17 Practice registrations of medical institutions shall be handled by the health administrative department of the people's government that approved the setup.
Practice registrations of medical institutions that are set up in accordance with the provisions of Article 13 hereof shall be handled by the health administrative departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government in the places where the medical institutions are located.
Practice registrations of out-patient departments, clinics, and health posts (rooms) that are set up by governmental agencies, enterprises and public institutions to provide services for their employees shall be handled by the health administrative department of the people's government at the county level in the places where the said medical institutions are located.

Article 18 Particulars for practice registration of a medical institution include:
1. name, address and main person in charge;
2. form of ownership;
3. medical subjects and number of beds; and
4. registered capital.

Article 19 Health administrative departments of local people's governments at the county level or above shall review the medical institutions within 45 days upon the acceptance of the applications for practice registration and in accordance with the Regulations and the basic standards for medical institutions. Where a medical institution passes the review, it shall be registered with a License for Practicing of Medical Institutions granted; where a medical institution fails the review, the applicant shall be notified of the review results in writing.

Article 20 Where a medical institution changes its name, address, main person in charge, medical subjects or number of beds, it shall handle the change registration with the original registration authority.

Article 21 Where a medical institution goes out of business, it must complete the cancellation of registration with the original registration authority. Upon the examination and approval by the registration authority, the License for Practicing of Medical Institutions shall be seized.
Where a medical institution suspends its business for more than one year for the reasons other than renovation, expansion or relocation, such suspension shall be deemed as closure of business.

Article 22 For medical institutions with less than 100 beds, their Licenses for Practicing of Medical Institutions shall be verified once every year; for those with 100 beds or more, their Licenses for Practicing of Medical Institutions shall be verified once every three years. The verification shall be carried out by the original registration authority.

Article 23 The License for Practicing of Medical Institutions shall not be forged, altered, sold, transferred or lent.
Where the License for Practicing of Medical Institutions is lost, the medical institute concerned shall timely report the loss to the original registration authority and apply for reissuance.

Chapter IV Practice

Article 24 Any entity or individual shall not carry out diagnosis and treatment activities without the License for Practicing of Medical Institutions.

Article 25 Practice of medical institutions must comply with the relevant laws, regulations and medical technical specifications.

Article 26 Medical institutions must put their Licenses for Practicing of Medical Institutions and specify their medical subjects, consultation hours and charging standards in conspicuous places.

Article 27 Medical institutions must carry out diagnosis and treatment activities according to the approved and registered medical subjects.

Article 28 Medical institutions shall not employ persons other than health technical personnel to engage in medical and health technical work.

Article 29 Medical institutions shall enhance the professional ethics of medical workers.

Article 30 Any medical worker with a medical institution must wear a badge with his/her name, position or title when they work.

Article 31 Medical institutions shall immediately rescue critically ill patients. For patients with the diseases that cannot be diagnosed and cured due to limited medical apparatus or technical conditions, they shall be promptly transferred to other hospitals.

Article 32 A medical institution shall not issue a diagnosis letter of disease, a health certificate or a death certificate or other documents without actual diagnosis and examination by a doctor (medical assistant) of the medical institution; it shall not issue a birth certificate or a stillbirth report if no obstetrician or midwife of the medical institution has delivered the baby.

Article 33 When a medical institution intends to perform an operation, special examination or special treatment, it must obtain the consent of the patient concerned and shall obtain the consent and signature of such patient's family member or relative; in the event that the patient's opinion cannot be obtained, the medical institution shall obtain the consent and signature of his/her family member or relative; If it is impossible to get the patient's opinion and there is no family member or relative of the patient available, or in other special circumstances, the doctor in charge shall put forward a medical treatment plan and carry it out after the plan is ratified by the principal person in charge of the medical institution or the authorized responsible person of the medical institution.

Article 34 Where a medical institution has a medical accident, such accident shall be handled in accordance with the relevant state provisions.

Article 35 Medical institutions shall perform special diagnosis and treatment for patients with infectious diseases, mental illness, occupational diseases and other diseases in accordance with the provisions of the relevant state laws and regulations.

Article 36 Medical institutions must strengthen drug administration in accordance with the relevant laws and regulations on drug administration.

Article 37 A medical institution shall, in accordance with the relevant provisions of the local people's government or price department, charge the medical fees, give the breakdown and issue the receipts.

Article 38 A medical institution must undertake appropriate work for disease prevention and health care, and fulfill the tasks of aiding the rural areas and instructing the medical and public health work of grassroots units as entrusted by health administrative departments of the people's governments at the county level or above.

Article 39 Where any major disaster, accident, epidemic disease or other unforeseen circumstance occurs, a medical institution and its medical workers must follow the orders of the health administrative department of the people's governments at the county level or above.

Chapter V Supervision and Administration

Article 40 The health administrative departments of the people's governments at the county level or above exercise the following powers of supervision and administration:
1. be responsible for approval of the setup, practice registration and verification of medical institutions;
2. inspect and guide practicing activities of medical institutions;
3. be responsible for organizing the review of medical institutions; and
4. impose punishment on acts in violation of the Regulations.

Article 41 The State applies the review system for medical institutions. The review committee of experts shall, in accordance with the review methods and review criteria for medical institutions, conduct the comprehensive evaluation on practicing activities, the quality of medical services and other aspects of a medical institution.
Review methods and review criteria for medical institutions are developed by the health administrative department under the State Council.

Article 42 Health administrative departments of local people's governments at the county level or above are responsible for organizing the review committees for medical institutions within their respective administrative regions.
A review committee for medical institutions consists of the relevant experts in respects of hospital administration, medical education, medical care, medical technology, nursing and finance. Members of the review committee shall be engaged by the health administrative department of the local people's government at the county level or above.

Article 43 Health administrative departments of the local people's governments at the county level or above shall, based on the review opinions of the review committees, grant certificates for passing the review to those medical institutions meeting the review criteria; or give handling opinions to those medical institutions failing to meet the review criteria.

Chapter VI Penalty Provisions

Article 44 Where a medical institution violates the provisions of Article 24 hereof, fails to obtain the License for Practicing of Medical Institutions, and practices without authorization, the health administrative department of the people's government at the county level or above shall order it to stop its practicing activities, confiscate illegal gains, medicines and instruments, and may impose a fine of less than CNY10,000 as the case may be.

Article 45 Where a medical institution violates the provisions of Article 22 hereof and still engages in diagnosis and treatment activities without having the License for Practicing of Medical Institutions verified, the health administrative department of the people's government at the county level or above shall order it to go through the verification formalities within a time limit; where the medical institution refuses to be verified, its License for Practicing of Medical Institutions shall be revoked.

Article 46 Where a medical institution violates the provisions of Article 23 hereof, and sells, transfers or lends the License for Practicing of Medical Institutions, the health administrative department of the people's government at the county level or above shall confiscate its illegal gains and may impose a fine of less than CNY5,000; where the circumstance is serious, the License for Practicing of Medical Institutions shall be revoked.

Article 47 Where a medical institution violates the provisions of Article 27 hereof with its diagnosis and treatment activities beyond the registered scope, the health administrative department of the people's government at the county level or above shall warn it and order it to make corrections, and may impose a fine of less than CNY3,000 as the case may be; where the circumstance is serious, the License for Practicing of Medical Institutions shall be revoked.

Article 48 Where a medical institution violates the provisions of Article 28 hereof and employs persons other than medical workers to engage in medical and health technical work, the health administrative department of the people's government at the county level or above shall order it to make corrections, and may impose a fine of less than CNY5,000; where the circumstance is serious, its License for Practicing of Medical Institutions shall be revoked.

Article 49 Where a medical institution violates the provisions of Article 32 hereof and issues false documents, the health administrative department of the people's government at the county level or above shall give a warning; if the case caused harmful consequences, the health administrative department of the people's government at the county level or above may impose a fine of less than CNY1,000; and administrative sanctions shall be imposed on direct responsible persons by the employers concerned or governmental agencies at a higher level.

Article 50 All confiscated properties and fines shall be handed in to the treasury.

Article 51 Where a party concerned disagrees with the decision of the administrative penalty, it may apply for administrative reconsideration or institute legal proceedings in accordance with the provisions of the national laws and regulations. Where the party concerned fails to apply for reconsideration or institutes legal proceedings within a legal time limit for the decision of such penalties as fines and confiscating drugs and instruments but does not fulfill the decision, the health administrative department of the people's government at the county level or above may apply to the people's court for mandatory enforcement.

Chapter VII Supplementary Provisions

Article 52 Medical institutions that have practiced before the enforcement of the Regulations shall, within six months after the Regulations take effect, go through registration formalities and obtain a License for Practicing of Medical Institutions in accordance with the provisions of Chapter III hereof.

Article 53 Administrative measures for setting up medical institutions by foreigners within the territory of the People's Republic of China and by residents from Hong Kong Region, Macao Region and Taiwan Region in the mainland of China shall be otherwise formulated by the health administrative department under the State Council.

Article 54 The health administrative department under the State Council is responsible for interpreting the Regulations.

Article 55 The Regulations shall come into force as of September 1, 1994. The Interim Administrative Regulations on Hospitals and Clinics approved and promulgated by the Government Administration Council in 1951 shall be repealed simultaneously.