(the State Council Order No.149 of the People’s Republic of China was issued on February 26, 1994, and was first revised according to the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016, and was second revised according to the Decision of the State Council on Amending and Abolishing Some Administrative Regulations on March 29, 2022).
Chapter I General Principles
Article 1 These Regulations are formulated for the purpose of strengthening the management of medical institutions, promoting the development of medical and health undertakings and ensuring the health of citizens.
Article 2 These Regulations shall apply to hospitals, health centers, sanatoriums, out-patient departments, clinics, health centers (rooms) and first-aid stations engaged in disease diagnosis and treatment.
Article 3 Medical institutions aim at saving lives, preventing and treating diseases and serving citizens’ health.
Article 4 The State supports the development of medical institutions and encourages the establishment of medical institutions in various forms.
Article 5 The administrative department of health of the State Council is responsible for the supervision and management of medical institutions throughout the country.
The health administrative department of the local people’s government at or above the county level shall be responsible for the supervision and administration of medical institutions within their respective administrative areas.
The competent health department of the People’s Liberation Army of China shall, in accordance with these regulations and the relevant provisions of the state, supervise and manage the military medical institutions.
Chapter II Examination and Approval of Planning Layout and Setup
Article 6 The health administrative department of the local people’s government at or above the county level shall formulate the plan for the establishment of medical institutions in its administrative region according to the population, medical resources, medical needs and the distribution of existing medical institutions in its administrative region.
Organs, enterprises and institutions can set up medical institutions according to their needs and incorporate them into the planning of local medical institutions.
Article 7 The local people’s governments at or above the county level shall incorporate the planning of setting up medical institutions into the local regional health development planning and the overall planning of urban and rural construction and development.
Article 8 The establishment of medical institutions shall conform to the planning for the establishment of medical institutions and the basic standards of medical institutions.
The basic standards of medical institutions shall be formulated by the administrative department of health of the State Council.
Ninth units or individuals to set up medical institutions, in accordance with the provisions of the State Council should apply for the approval of the establishment of medical institutions, should be examined and approved by the health administrative department of the local people’s government at or above the county level, and obtain the approval of the establishment of medical institutions.
Article 10 To apply for the establishment of a medical institution, the following documents shall be submitted:
(1) Application for establishment;
(two) the feasibility study report;
(three) site selection report and architectural design plan.
Eleventh units or individuals to set up medical institutions, shall apply for the establishment in accordance with the following provisions:
(1) Medical institutions with no beds or fewer than 100 beds shall apply to the health administrative department of the local people’s government at the county level;
(two) medical institutions and specialized hospitals with more than 100 beds shall apply in accordance with the provisions of the health administrative department of the provincial people’s government.
Twelfth health administrative departments of local people’s governments at or above the county level shall, within 30 days from the date of accepting the application for establishment, give a written reply of approval or disapproval; If the establishment is approved, an approval letter for the establishment of a medical institution shall be issued.
Thirteenth national unified planning of medical institutions, decided by the administrative department of health of the State Council.
The third chapter is recorded
Fourteenth medical institutions to practice, must be registered and obtain a "medical institution practice license"; Clinics can practice after filing with the health administrative department of the local people’s government at the county level in accordance with the provisions of the health administrative department of the State Council.
Article 15 To apply for the practice registration of a medical institution, the following conditions shall be met:
(a) in accordance with the provisions should apply for the approval of the establishment of medical institutions, has obtained the approval of the establishment of medical institutions;
(2) meeting the basic standards of medical institutions;
(3) Having a suitable name, organization and place;
(4) Having funds, facilities, equipment and professional health technicians suitable for its business;
(5) Having corresponding rules and regulations;
(6) Being able to bear civil liability independently.
Article 16 The practice registration of a medical institution shall be handled by the health administrative department of the people’s government that approved its establishment; The practice registration of medical institutions that do not need to apply for the approval of medical institutions shall be handled by the health administrative department of the local people’s government at or above the county level.
The practice registration of medical institutions established in accordance with the provisions of Article 13 of these Regulations shall be handled by the health administrative department of the local people’s government of the province, autonomous region or municipality directly under the Central Government.
The practice registration or filing of outpatient departments, health centers (rooms) and clinics set up by organs, enterprises and institutions to serve internal employees shall be handled by the health administrative department of the local people’s government at the county level.
Article 17 The main items of practice registration of medical institutions:
(1) Name, address and main person in charge;
(2) Form of ownership;
(three) diagnosis and treatment subjects, beds;
(4) Registered capital.
Eighteenth health administrative departments of local people’s governments at or above the county level shall, within 45 days from the date of accepting the application for practice registration, conduct an audit according to these regulations and the basic standards of medical institutions. Those who pass the examination shall be registered and issued a Practice License for Medical Institutions; If the audit is unqualified, the applicant shall be informed of the audit results in writing.
Nineteenth medical institutions to change the name, place, main person in charge, diagnosis and treatment subjects, beds, must go through the change registration with the original registration authority or the original filing authority for the record.
Twentieth medical institutions to close down, must go through the cancellation of registration with the original registration authority or the original filing authority for the record. After being approved by the registration authority, the Practice License of Medical Institution shall be confiscated.
Medical institutions that have been closed for more than one year for reasons other than reconstruction, expansion or relocation shall be deemed to be closed.
Twenty-first medical institutions with less than 100 beds, the "Practice License of Medical Institutions" shall be checked once a year; For medical institutions with more than 100 beds, the Practice License of Medical Institutions shall be checked once every 3 years. The verification shall be handled by the original registration authority.
Article 22 The Practice License for Medical Institutions shall not be forged, altered, sold, transferred or lent.
If the Practice License of Medical Institution is lost, it shall be declared in time and apply to the original registration authority for a replacement.
The fourth chapter of the industry
Twenty-third any unit or individual, without obtaining the "practice license of medical institutions" or without filing, shall not carry out medical activities.
Twenty-fourth medical institutions must abide by the relevant laws, regulations and medical technical specifications.
Twenty-fifth medical institutions must hang the "Practice License of Medical Institutions", diagnosis and treatment subjects, diagnosis and treatment time and charging standards in obvious places.
Twenty-sixth medical institutions must carry out medical activities in accordance with the approved registration or filing of medical subjects.
Twenty-seventh medical institutions shall not use non-health technical personnel to engage in medical and health technical work.
Twenty-eighth medical institutions should strengthen medical ethics education for medical staff.
Twenty-ninth medical institutions staff work, must wear a sign containing my name, position or title.
Thirtieth medical institutions should immediately rescue critically ill patients. Patients who cannot be diagnosed and treated due to limited equipment or technical conditions shall be referred in time.
Article 31 A medical institution shall not issue a certificate of disease diagnosis, health certificate or death certificate without a doctor (doctor) personally examining the patient; A medical institution shall not issue a birth certificate or stillbirth report without a doctor or midwife personally taking delivery.
Thirty-second medical personnel should explain the condition and medical measures to patients in medical activities. If surgery, special examination and special treatment are needed, medical personnel shall explain the medical risks and alternative medical schemes to patients in a timely manner, and obtain their clear consent; If it is impossible or inappropriate to explain it to the patient, it shall explain it to the patient’s close relatives and obtain their clear consent. If the opinions of patients or their close relatives cannot be obtained due to emergency situations such as saving dying patients, corresponding medical measures can be implemented immediately with the approval of the person in charge of the medical institution or the authorized person in charge.
Article 33 Medical accidents in medical institutions shall be handled in accordance with relevant state regulations.
Article 34 The special diagnosis, treatment and treatment of patients with infectious diseases, mental diseases and occupational diseases by medical institutions shall be handled in accordance with the provisions of relevant state laws and regulations.
Article 35 Medical institutions must strengthen drug management in accordance with the laws and regulations on drug management.
Thirty-sixth medical institutions must collect medical expenses in accordance with the relevant provisions of the people’s government or the price department, make a detailed list and issue a receipt.
Thirty-seventh medical institutions must undertake the corresponding prevention and health care work, and undertake the tasks of supporting rural areas and guiding grassroots medical and health work entrusted by the health administrative department of the people’s government at or above the county level.
Article 38 In case of major disasters, accidents, epidemic diseases or other unexpected situations, medical institutions and their health technicians must obey the assignment of the health administrative department of the people’s government at or above the county level.
Chapter V Supervision and Administration
Article 39 The health administrative department of the people’s government at or above the county level shall exercise the following supervisory and administrative functions and powers:
(1) To be responsible for the examination and approval of the establishment, practice registration, filing and verification of medical institutions;
(two) to inspect and guide the practice activities of medical institutions;
(three) responsible for organizing the evaluation of medical institutions;
(four) to punish acts in violation of these regulations.
Article 40 The state practices an accreditation system for medical institutions, and an accreditation committee composed of experts comprehensively evaluates the practice activities and medical service quality of medical institutions according to the accreditation methods and standards of medical institutions.
The evaluation methods and standards of medical institutions shall be formulated by the administrative department of health of the State Council.
Article 41 The health administrative department of the local people’s government at or above the county level shall be responsible for organizing the evaluation committee of medical institutions in its administrative region.
The review committee of medical institutions is composed of experts in hospital management, medical education, medical treatment, medical technology, nursing and finance. Members of the review committee shall be appointed by the health administrative department of the local people’s government at or above the county level.
Forty-second health administrative departments of local people’s governments at or above the county level shall, according to the evaluation opinions of the evaluation committee, issue a certificate of accreditation to medical institutions that meet the evaluation standards; For medical institutions that fail to meet the evaluation criteria, put forward treatment opinions.
Chapter VI Penalty Rules
Forty-third in violation of the provisions of article twenty-third, without obtaining the "practice license of medical institutions", shall be punished in accordance with the provisions of the "People’s Republic of China (PRC) basic medical and health promotion law".
In violation of the provisions of article twenty-third, the health administrative department of the people’s government at or above the county level shall order it to make corrections, confiscate the illegal income and impose a fine of 30 thousand yuan; Refuses to correct, shall be ordered to stop practicing activities.
Article 44 If anyone, in violation of the provisions of Article 21 of these regulations, fails to verify the Practice License of Medical Institution within the time limit and still engages in clinical activities, the health administrative department of the people’s government at or above the county level shall order him to go through the verification procedures within a time limit; Refuse to check, revoke its "medical institution practice license".
Article 45 Whoever, in violation of the provisions of Article 22 of these regulations, sells, transfers or lends the Practice License of Medical Institutions shall be punished in accordance with the provisions of the Law of People’s Republic of China (PRC) on Basic Medical Hygiene and Health Promotion.
Article 46. Anyone who, in violation of the provisions of Article 26 of these regulations, conducts diagnosis and treatment activities beyond the scope of registration or filing shall be given a warning by the health administrative department of the people’s government at or above the county level, ordered to make corrections, his illegal income shall be confiscated, and he may be fined between 10,000 yuan and 100,000 yuan according to the circumstances; If the circumstances are serious, its Practice License of Medical Institution shall be revoked or it shall be ordered to stop practicing.
Article 47 Whoever, in violation of the provisions of Article 27 of these regulations, uses non-health technicians to engage in medical and health technical work shall be ordered by the health administrative department of the people’s government at or above the county level to make corrections within a time limit and may be fined between 10,000 yuan and 100,000 yuan; If the circumstances are serious, its Practice License of Medical Institution shall be revoked or it shall be ordered to stop practicing.
Forty-eighth in violation of the provisions of article thirty-first, issued false documents, shall be given a warning by the health administrative department of the people’s government at or above the county level; Those who cause harmful consequences may be fined between 10,000 yuan and 100,000 yuan; The persons who are directly responsible shall be given administrative sanctions by their units or higher authorities.
Article 49 All confiscated property and fines shall be turned over to the state treasury.
Fiftieth if a party refuses to accept the decision on administrative punishment, it may apply for administrative reconsideration or bring an administrative lawsuit in accordance with the provisions of national laws and regulations. If the party concerned fails to apply for reconsideration or bring a lawsuit within the statutory time limit and fails to perform the punishment decision on fines and confiscation of drugs and devices, the health administrative department of the people’s government at or above the county level may apply to the people’s court for compulsory execution.
Chapter VII Supplementary Provisions
Article 51 Medical institutions that have practiced before the implementation of these Regulations shall, within six months after the implementation of these Regulations, go through the registration formalities in accordance with the provisions of Chapter III of these Regulations and obtain the Practice License for Medical Institutions.
Article 52 The administrative measures for foreigners to set up medical institutions in People’s Republic of China (PRC) and Hongkong, Macao and Taiwan Province residents to set up medical institutions in the Mainland shall be formulated separately by the health administrative department of the State Council.
Article 53 These Regulations shall come into force as of September 1, 1994. In 1951, the Provisional Regulations on the Management of Hospital Clinics, which was approved by the State Council, was abolished at the same time.