Regulation on the Administration of Medical Institutions (2016 Revision)

· Document Number：Order No. 666 of the State Council

· Area of Law： Health and Sanitation

· Level of Authority： Administrative Regulations

· Date issued：02-06-2016

· Effective Date：09-01-1994

· Status： Effective

· Issuing Authority： State Council

Regulation on the Administration of Medical Institutions
(Promulgated by the Order No. 149 of the State Council of the People's Republic of China on February 26, 1994; and revised in accordance with the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016)
Chapter I General Provisions
Article 1 This Regulation is developed for purposes of strengthening the administration of medical institutions, promoting the development of the medical and health cause, and protecting the health of citizens.
Article 2 This Regulation shall apply to hospitals, health centers, nursing homes, out-patient departments, clinics, health clinics (stations), first aid stations and other medical institutions engaging in the diagnosis and treatment of diseases.
Article 3 Medical institutions aim at retrieving the dying or rescuing the wounded, preventing and curing disease, and serving for the health of citizens.
Article 4 The state shall support the development of medical institutions and encourage the establishment of medical institutions in various forms.
Article 5 The health administrative department of the State Council shall be responsible for the supervision and administration of the medical institutions across the country.
The health administrative departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of the medical institutions within their respective administrative regions.
The competent health department of the Chinese People's Liberation Army shall, under this Regulation and the relevant provisions of the state, implement supervision and administration of the medical institutions of the Army.
Chapter II Approval for Planning Layout and Formation
Article 6 The health administrative departments of the local people's governments at or above the county level shall, according to the population, medical resources, medical needs and the distribution of the existing medical institutions in their respective administrative regions, develop plans for the formation of medical institutions within their respective administrative regions.
Organs, enterprises and public institutions may, according to the needs, form medical institutions and incorporate them into the plans for the formation of local medical institutions.
Article 7 The local people's governments at or above the county level shall incorporate the plans for the formation of medical institutions into the local regional health development plans and overall plans for urban and rural construction and development.
Article 8 The formation of medical institutions shall comply with the plans for the formation of medical institutions and the basic standards for medical institutions.
The basic standards for medical institutions shall be developed by the health administrative department of the State Council.
Article 9 To form a medical institution, an entity or individual shall be subject to the examination and approval of the health administrative department of the local people's government at or above the county level and obtain the written approval for the formation of medical institutions.
Article 10 To apply for forming a medical institution, an applicant shall submit the following documents:
(1) a written application for the formation;
(2) a feasibility study report for the formation; and
(3) a site selection report and the drawings of architectural design.
Article 11 To form a medical institution, an entity or individual shall file an application for formation under the following provisions:
(1) For a medical institution that has no sickbeds or has less than 100 sickbeds, an application shall be filed with the health administrative department of the people's government of the county where it is located.
(2) For a medical institution or specialized hospital that has more than 100 sickbeds, an application shall be filed under the provisions of the health administrative department of the people's government at the provincial level.
Article 12 The health administrative department of the local people's government at or above the county level shall, within 30 days of the date of accepting an application for formation, issue a written reply of approval or disapproval; and issue a written approval for the formation of an institution, where approval is granted.
Article 13 The formation of medical institutions under the unified plan of the state shall be decided by the health administrative department of the State Council.
Article 14 Organs, enterprises and public institutions that form out-patient departments, clinics and health clinics (stations) serving their employees according to the basic standards of the state for medical institutions shall submit the relevant materials to the health administrative departments of the people's governments of the county where they are located for recordation.
Chapter III Registration
Article 15 A medical institution providing relevant services shall conduct registration and obtain the Practicing License for a Medical Institution.
Article 16 To apply for practicing registration, a medical institution shall meet the following conditions:
(1) It has a written approval for the formation of a medical institution.
(2) It complies with the basic standards for medical institutions.
(3) It has an appropriate name, organizing institution and place.
(4) It has funds, facilities, equipment and professional health technical personnel that are compatible with the business carried out.
(5) It has corresponding rules and regulations.
(6) It is able to independently assume civil responsibilities.
Article 17 The practicing registration of medical institutions shall be handled by the health administrative departments of the people's governments approving their formation.
The practicing registration of medical institutions formed under the provisions of Article 13 of this Regulation 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 where they are located.
The practicing registration of the out-patient departments, clinics and health clinics (stations) formed by organs, enterprises and public institutions for serving their employees shall be handled by the health administrative departments of the people's governments of the county where they are located.
Article 18 The main items of the practicing registration of a medical institution include:
(1) the name, address and primary person in charge;
(2) the form of system of ownership;
(3) the diagnostic and treatment items, and sickbeds; and
(4) the registered capital.
Article 19 The health administrative department of the local people's government at or above the county level shall, within 45 days of the date of accepting an application for practicing registration, conduct verification according to this Regulation and the basic standards for medical institutions. It shall handle registration for an applicant passing the verification and issue a Practicing License for a Medical Institution; and notify the applicant failing to pass the verification of the verification result in writing.
Article 20 A medical institution changing its name, site, primary person in charge, diagnostic and treatment items, and sickbeds shall undergo the formalities of modification registration with the original registration authority.
Article 21 A medical institution closing its business shall undergo the formalities of deregistration with the original registration authority. With the approval of the registration authority, the Practicing License for a Medical Institution shall be taken over.
A medical institution that ceases business for over 1 year due to reasons other than reconstruction, extension and relocation shall be deemed closing business.
Article 22 For a medical institution with less than 100 sickbeds, its Practicing License for a Medical Institution shall be verified once a year; and for a medical institution with more than 100 sickbeds, its Practicing License for a Medical Institution shall be verified once every three years. The verification shall be handled by the original registration authority.
Article 23 A Practicing License for a Medical Institution shall not be fabricated, altered, sold, transferred or lent.
A medical institution that loses its Practicing License for a Medical Institution shall make a declaration in a timely manner and apply to the original registration authority for reissue.
Chapter IV Practicing
Article 24 Any entity or individual that has not obtained a Practicing License for a Medical Institution shall not carry out diagnosis or treatment activities.
Article 25 A medical institution shall provide relevant services under relevant laws and regulations and the technical specifications for medical care.
Article 26 A medical institution shall hang its Practicing License for a Medical Institution, diagnostic and treatment items, diagnosis and treatment time and fee standards at an eye-catching place.
Article 27 A medical institution shall carry out diagnosis and treatment activities according to the diagnostic and treatment items verified and registered.
Article 28 No medical institution shall employ any non-health technician to engage in medical or health technical work.
Article 29 Medical institutions shall strengthen the education of medical ethics for medical staff members.
Article 30 Staff members of a medical institution shall wear name tags specifying their names, posts or professional titles.
Article 31 Medical institutions shall immediately rescue critically ill patients. Patients that are unable to receive diagnosis or treatment due to restriction of equipment or technical conditions shall be transferred in a timely manner.
Article 32 Any medical institution shall not issue disease certificate, health certificate, death certificate, or any other supporting documents to any patient that has not received diagnosis or examination of a doctor (junior doctor); and any medical institution shall not issue any birth certificate or dead birth report to any baby that is not delivered in person by an obstetrician (junior obstetrician) or midwife.
Article 33 When offering surgery, special examination or special treatment, a medical institution shall obtain the consent of a patient, and obtain the consent and signature of his or her family or related; when the consent of a patient is unavailable, the medical institution shall obtain the consent and signature of his or her family or related; and where the opinions of a patient are unavailable and there is no family or related on the scene, or other special circumstances are present, the managing physician shall offer a medical treatment plan and implement the plan after obtaining the approval of the principal person in charge of the medical institution or the authorized responsible person.
Article 34 Medical institutions that have medical negligence shall be punished under the relevant provisions of the state.
Article 35 The special diagnosis, treatment and care for patients suffering infectious diseases, mental diseases, occupational diseases and other diseases shall be handled under the provisions of the relevant laws and regulations of the state.
Article 36 Medical institutions shall strengthen pharmaceutical administration under the laws and regulations on pharmaceutical administration.
Article 37 A medical institution shall, according to the relevant provisions of the people's government or the price bureau, collect medical fees, list the items in a detailed manner, and issue invoices.
Article 38 A medical institution shall assume corresponding prevention and health care work, and assume the tasks such as supporting the rural areas and directing the basic medical and health work entrusted by the health administrative department of the people's government at or above the county level.
Article 39 In the event of major disaster, accident, epidemic or other accident, a medical institution and its health technical personnel shall obey the dispatch of the health administrative department of the people's government at or above the county level.
Chapter V Supervision and Administration
Article 40 A health administrative department of the people's government at or above the county level shall exercise the following supervision and administration functions:
(1) It shall be responsible for the approval for the formation, practicing registration and verification of the medical institutions.
(2) It shall provide examination guidance for the practicing activities of medical institutions.
(3) It shall be responsible for organizing the examination and evaluation of medical institutions.
(4) It shall punish the violators that have acts in violation of the Regulation.
Article 41 The state shall implement the review system for medical institutions and the review committee composed of experts shall, according to the methods for the review of medical institutions and the review standards, conduct comprehensive evaluation of the practicing activities, quality of medical services and other items of the medical institutions.
The review methods and review standards for medical institutions shall be developed by the health administrative department of the State Council.
Article 42 The health administrative departments of the local people's governments at or above the county level shall be responsible for organizing the review committees of the medical institutions within their respective administrative regions.
The review committee of medical institutions shall consist of relevant experts in hospital management, medical education, medical care, medical technology, nursing, finance, and other respects. The members of the review committees shall be appointed by the health administrative departments of the local people's governments at or above the county level.
Article 43 The health administrative departments of the local people's governments at or above the county level shall, according to the review opinions of the review committee, issue certificates of passing the review to the medical institutions meeting the review standards; and shall offer handling opinions to medical institutions failing to meet the review standards.
Chapter VI Penalty Provisions
Article 44 A medical institution that provides relevant services without obtaining the Practicing License for a Medical Institution in violation of the provisions of Article 24 of this Regulation shall be ordered by the health administrative department of the people's government at or above the county level to cease its practicing activities, shall be subject to confiscation of illegal income, drugs and instrument, and may be fined no more than 10,000 yuan in light of the circumstances.
Article 45 A medical institution that still carries out diagnosis or treatment activities without verification of its Practicing License for a Medical Institution within the prescribed time limit in violation of the provisions of Article 22 of this Regulation shall be ordered by the health administrative department of the people's government at or above the county level to undergo the verification formalities within the prescribed time limit; and a medical institution that rejects the verification shall be subject to withdrawal of the Practicing License for a Medical Institution.
Article 46 A medical institution that sells, transfers or lends its Practicing License for a Medical Institution in violation of the provisions of Article 23 of this Regulation shall be subject to the confiscation of the illegal income by the health administrative department of the people's government at or above the county level and may be fined no more than 5,000 yuan; and under serious circumstances, the medical institution shall be subject to withdrawal of its Practicing License for a Medical Institution.
Article 47 A medical institution that carries out diagnosis and treatment activities beyond the registered scope in violation of the provisions of Article 27 of this Regulation shall be given a warning by the health administrative department of the people's government at or above the county level and be ordered by the aforesaid department to take corrective action, and may be fined no more than 3,000 yuan in light of the circumstances; and under serious circumstances, the medical institution shall be subject to withdrawal of its Practicing License for a Medical Institution.
Article 48 A medical institution that employs non-health technicians to engage in medical and health technical work in violation of the provisions of Article 28 of this Regulation shall be ordered by the health administrative department of the people's government at or above the county level to take corrective action within the prescribed time limit, and may be fined no more than 5,000 yuan; and under serious circumstances, the medical institution shall be subject to withdrawal of its Practicing License for a Medical Institution.
Article 49 A medical institution that produces false supporting documents in violation of the provisions of Article 32 of this Regulation shall be given a warning by the health administrative department of the people's government at or above the county level; a medical institution that has caused any hazardous consequence may be fined no more than 1,000 yuan; and the direct liable person shall be given administrative sanction by his or her employer or an organ at a higher level.
Article 50 The property confiscated and the fines shall be totally turned over to the state treasury.
Article 51 A party that refuses to accept an administrative penalty may, under the provisions of the laws and regulations of the state, apply for administrative reconsideration or institute an administrative action. Where a party does not apply for reconsideration or institute any lawsuit against a penalty decision of fine and confiscation of drugs and instrument within the statutory time limit and refuses to fulfill the decision, 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 52 Medical institutions that have provided relevant services before this Regulation comes into force shall, within 6 months of this Regulation's entry into force, undergo the registration formalities and obtain the Practicing License for a Medical Institution under the provisions of Chapter III of this Regulation.
Article 53 The measures for the administration of the medical institutions formed by foreigners within the territory of the People's Republic of China and the medical institutions formed by the residents of Hong Kong, Macao and Taiwan in the Mainland shall be separately developed by the health administrative department of the State Council.
Article 54 The power to interpret this Regulation shall remain with the health administrative department of the State Council.
Article 55 This Regulation shall come into force on September 1, 1994. The Interim Regulation on the Administration of Hospitals and Clinics approved to be issued by the Government Administration Council in 1951 shall be concurrently repealed.