Promulgated by: State Council of the People’s Republic of China. Document No.: State Council Decree No. 149 (1994); amended by State Council Decree No. 666 (2016) and State Council Decree No. 752 (2022). Adopted on February 26, 1994. Effective September 1, 1994. Second amendment promulgated March 29, 2022, effective May 1, 2022.
Chapter I General Provisions
Article 1. This Regulation is formulated in order to strengthen the administration of medical institutions, promote the development of the medical and health cause, and protect the health of citizens.
Article 2. This Regulation applies to hospitals, health centres, sanatoria, out-patient departments, clinics, health stations (rooms), first-aid stations, and other medical institutions that engage in disease diagnosis and treatment activities.
Article 3. Medical institutions shall operate with the purpose of saving lives and healing the sick, preventing and treating disease, and serving the health of citizens.
Article 4. The State supports the development of medical institutions and encourages the establishment of medical institutions in diverse forms.
Article 5. The health administrative department of the State Council is responsible for the supervision and administration of medical institutions throughout the country. The health administrative departments of local people’s governments at or above the county level are responsible for the supervision and administration of medical institutions within their respective administrative regions. The health authority of the Chinese People’s Liberation Army shall, in accordance with this Regulation and relevant State provisions, supervise and administer military medical institutions.
Chapter II Planning, Layout, and Approval for Establishment
Article 6. The health administrative department of a local people’s government at or above the county level shall, based on the population, medical resources, medical needs, and distribution of existing medical institutions within its administrative region, formulate a plan for the establishment of medical institutions in that region. Organs, enterprises, and public institutions may establish medical institutions according to their needs, and such institutions shall be incorporated into the local plan for medical institution establishment.
Article 7. Local people’s governments at or above the county level shall incorporate medical institution establishment plans into their regional health development plans and overall plans for urban and rural development.
Article 8. The establishment of a medical institution shall conform to the medical institution establishment plan and to the basic standards for medical institutions. The basic standards for medical institutions shall be formulated by the health administrative department of the State Council.
Article 9. Any entity or individual that establishes a medical institution and, in accordance with State Council provisions, is required to obtain a Certificate of Approval for Establishment of a Medical Institution, shall apply to the health administrative department of the local people’s government at or above the county level for examination and approval, and shall obtain a Certificate of Approval for Establishment of a Medical Institution.
Article 10. An application to establish a medical institution shall be submitted together with the following documents: (1) an application for establishment; (2) a feasibility study report on establishment; and (3) a site-selection report and a floor plan of the proposed building.
Article 11. An entity or individual establishing a medical institution shall submit an application for establishment in accordance with the following provisions: (1) for a medical institution with no beds or with fewer than 100 beds, the application shall be submitted to the health administrative department of the county-level people’s government at the location of the institution; (2) for a medical institution with 100 or more beds, and for specialised hospitals, the application shall be submitted in accordance with the provisions of the health administrative department of the provincial-level people’s government.
Article 12. The health administrative department of a local people’s government at or above the county level shall, within 30 days of accepting an application for establishment, issue a written reply granting or refusing approval.
Article 13. The establishment of medical institutions that are planned in a unified manner by the State shall be decided by the health administrative department of the State Council.
Chapter III Registration
Article 14. A medical institution shall register before commencing practice and shall obtain a Licence for Practice of Medical Institution; a clinic may commence practice after filing with the health administrative department of the county-level people’s government at its location in accordance with the provisions of the health administrative department of the State Council.
Article 15. An application for registration to practice as a medical institution shall satisfy the following conditions: (1) where a Certificate of Approval for Establishment of a Medical Institution is required under the applicable rules, such certificate has been obtained; (2) the institution conforms to the basic standards for medical institutions; (3) the institution has an appropriate name, organisational structure, and premises; (4) the institution has funds, facilities, equipment, and qualified health technicians commensurate with the business it will carry on; (5) the institution has corresponding rules and regulations; and (6) the institution is capable of bearing 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 a medical institution that is not required to obtain a Certificate of Approval for Establishment of a Medical Institution shall be handled by the health administrative department of the local people’s government at or above the county level at the institution’s location. The practice registration of a medical institution established under Article 13 of this Regulation shall be handled by the health administrative department of the people’s government of the province, autonomous region, or municipality directly under the central government at the institution’s location. The practice registration or filing of an out-patient department, health station (room), or clinic established by an organ, enterprise, or public institution to serve its own employees shall be handled by the health administrative department of the county-level people’s government at the institution’s location.
Article 17. The main particulars to be recorded in the practice registration of a medical institution are: (1) name, address, and principal person in charge; (2) form of ownership; (3) approved clinical departments and bed number; and (4) registered capital.
Article 18. The health administrative department of a local people’s government at or above the county level shall, within 45 days of accepting an application for practice registration, conduct an examination in accordance with this Regulation and the basic standards for medical institutions. If the examination result is satisfactory, the institution shall be registered and issued a Licence for Practice of Medical Institution.
Article 19. Where a medical institution changes its name, premises, principal person in charge, clinical departments, or bed number, it must apply to the original registration authority for a change of registration or file with the original filing authority.
Article 20. Where a medical institution suspends operations, it must apply to the original registration authority for cancellation of registration or file with the original filing authority. A medical institution that suspends operations for more than one year for reasons other than reconstruction, expansion, or relocation shall be deemed to have suspended operations permanently.
Article 21. A medical institution with fewer than 100 beds shall have its Licence for Practice of Medical Institution verified once every year; a medical institution with 100 or more beds shall have its Licence for Practice of Medical Institution verified once every three years.
Article 22. A Licence for Practice of Medical Institution may not be forged, altered, sold, transferred, or lent. If a licence is lost, the loss shall be declared promptly and an application for a replacement shall be submitted to the original registration authority.
Chapter IV Practice
Article 23. No entity or individual may engage in diagnosis and treatment activities without having obtained a Licence for Practice of Medical Institution or without having completed a filing.
Article 24. In practising, a medical institution must comply with the relevant laws, regulations, and medical and technical standards.
Article 25. A medical institution must display its Licence for Practice of Medical Institution, the clinical departments it offers, its practice hours, and its schedule of charges in a conspicuous location.
Article 26. A medical institution must engage in diagnosis and treatment activities within the clinical departments for which it has been approved by registration or filing.
Article 27. A medical institution may not use persons who are not qualified health technicians to perform medical and health technical work.
Article 28. A medical institution shall strengthen medical ethics education for its medical staff.
Article 29. Personnel working at a medical institution must wear a badge displaying their name and position or professional title while on duty.
Article 30. A medical institution shall immediately provide emergency treatment to critically ill patients. Where a patient cannot be diagnosed or treated due to limitations of equipment or technical capacity, the institution shall arrange for the timely referral of the patient.
Article 31. Without a physician (or doctor’s assistant) having personally examined the patient, a medical institution may not issue a certificate of disease diagnosis, a certificate of health, a death certificate, or other such certification documents; without a physician (or doctor’s assistant) or a midwife having personally attended the delivery, a medical institution may not issue a birth certificate or a stillbirth report.
Article 32. During the course of diagnosis and treatment, medical personnel shall explain to patients their condition and the medical measures to be taken. Where surgery, a special examination, or special treatment is to be performed, the medical personnel shall promptly explain to the patient in specific terms the medical risks, alternative treatment options, and other relevant matters, and shall obtain the patient’s explicit consent; where it is not possible or appropriate to explain to the patient, the explanation shall be given to the patient’s close relatives and their explicit consent shall be obtained. Where, due to an emergency such as rescuing a patient who is critically ill, it is impossible to obtain the opinion of the patient or their close relatives, the medical institution’s person in charge or an authorised person in charge may approve the immediate implementation of appropriate medical measures.
Article 33. Medical incidents occurring at a medical institution shall be handled in accordance with the relevant State provisions.
Article 34. Where a medical institution provides special diagnosis, treatment, and handling for patients with infectious diseases, mental illness, occupational diseases, and the like, it shall do so in accordance with the relevant laws and regulations of the State.
Article 35. A medical institution must strengthen the administration of pharmaceutical products in accordance with the relevant laws and regulations on pharmaceutical administration.
Article 36. A medical institution must collect medical fees in accordance with the relevant provisions of the people’s government or the pricing authority, itemise charges in detail, and issue receipts.
Article 37. A medical institution must undertake corresponding work in disease prevention and health care, and must carry out tasks such as supporting rural areas and guiding primary-level medical and health work as assigned by the health administrative department of the people’s government at or above the county level.
Article 38. In the event of a major disaster, accident, epidemic, or other emergency, a medical institution and its health technical personnel must comply with the deployment arrangements 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 a people’s government at or above the county level shall exercise the following powers of supervision and administration: (1) responsibility for approval of establishment, practice registration, filing, and verification of medical institutions; (2) inspection and guidance of the practice activities of medical institutions; (3) responsibility for organising the evaluation of medical institutions; and (4) imposition of penalties on conduct that violates this Regulation.
Article 40. The State implements a system of medical institution evaluation. An evaluation committee composed of experts shall conduct a comprehensive assessment of the practice activities, quality of medical services, and other matters of medical institutions in accordance with the medical institution evaluation methods and evaluation standards. The medical institution evaluation methods and evaluation standards shall be formulated by the health administrative department of the State Council.
Article 41. The health administrative department of a local people’s government at or above the county level is responsible for organising the medical institution evaluation committee in its administrative region. The medical institution evaluation committee shall be composed of relevant experts in hospital management, medical education, clinical medicine, medical technology, nursing, finance, and related fields. Members of the evaluation committee shall be appointed by the health administrative department of the local people’s government at or above the county level.
Article 42. Based on the evaluation opinions of the evaluation committee, the health administrative department of the local people’s government at or above the county level shall issue a certificate of qualified evaluation to medical institutions that have met the evaluation standards, and shall propose handling opinions for medical institutions that have not met the evaluation standards.
Chapter VI Penalties
Article 43. Where a medical institution operates in violation of Article 23 of this Regulation without having obtained a Licence for Practice of Medical Institution, penalties shall be imposed in accordance with the Law of the People’s Republic of China on the Promotion of Basic Medical and Health Care. Where a clinic operates in violation of Article 23 of this Regulation without having completed the required filing, the health administrative department of the people’s government at or above the county level shall order it to make corrections, confiscate any illegal gains, and impose a fine of not more than 30,000 yuan; where the institution refuses to make corrections, it shall be ordered to cease practice activities.
Article 44. Where a medical institution, in violation of Article 21 of this Regulation, continues to engage in diagnosis and treatment activities after the deadline for verification of its Licence for Practice of Medical Institution has passed without completing verification, the health administrative department of the people’s government at or above the county level shall order it to complete verification within a time limit; where it refuses to undergo verification, its Licence for Practice of Medical Institution shall be revoked.
Article 45. Where a Licence for Practice of Medical Institution is sold, transferred, or lent in violation of Article 22 of this Regulation, penalties shall be imposed in accordance with the Law of the People’s Republic of China on the Promotion of Basic Medical and Health Care.
Article 46. Where a medical institution, in violation of Article 26 of this Regulation, engages in diagnosis and treatment activities outside the scope of its registered or filed clinical departments, the health administrative department of the people’s government at or above the county level shall issue a warning, order it to make corrections, confiscate any illegal gains, and may impose a fine of not less than 10,000 yuan and not more than 100,000 yuan depending on the circumstances; in serious cases, its Licence for Practice of Medical Institution shall be revoked or it shall be ordered to cease practice activities.
Article 47. Where a medical institution, in violation of Article 27 of this Regulation, uses persons who are not qualified health technicians to perform medical and health technical work, the health administrative department of the people’s government at or above the county level shall order it to make corrections within a time limit and may impose a fine of not less than 10,000 yuan and not more than 100,000 yuan; in serious cases, its Licence for Practice of Medical Institution shall be revoked or it shall be ordered to cease practice activities.
Article 48. Where a medical institution, in violation of Article 31 of this Regulation, issues false certification documents, the health administrative department of the people’s government at or above the county level shall issue a warning; where harm has resulted, a fine of not less than 10,000 yuan and not more than 100,000 yuan may be imposed; and the directly responsible persons shall be subject to administrative sanctions by the unit to which they belong or by the authority at a higher level.
Article 49. Confiscated property and fines shall be paid in full into the State treasury.
Article 50. A party that is dissatisfied with an administrative penalty decision may apply for administrative reconsideration or bring an administrative lawsuit in accordance with the laws and regulations of the State. Where a party has neither applied for reconsideration nor instituted legal proceedings within the statutory time limit and has failed to comply with the penalty decision imposing a fine or ordering confiscation of pharmaceutical products or equipment, the health administrative department of the people’s government at or above the county level may apply to the people’s court for compulsory enforcement.
Chapter VII Supplementary Provisions
Article 51. Medical institutions that were already in practice before this Regulation came into effect shall, within six months after this Regulation comes into effect, complete the registration procedures and obtain a Licence for Practice of Medical Institution in accordance with Chapter III of this Regulation.
Article 52. Measures for the administration of medical institutions established in the territory of the People’s Republic of China by foreigners, and of medical institutions established in the mainland by residents of Hong Kong, Macao, and Taiwan, shall be separately formulated by the health administrative department of the State Council.
Article 53. This Regulation shall come into force on September 1, 1994. The Interim Regulations on the Administration of Hospitals and Clinics, approved and issued by the Government Administration Council in 1951, are simultaneously repealed.