KYB CHINA(1994年2月26日中华人民共和国国务院令第149号发布 根据2016年2月6日《国务院关于修改部分行政法规的决定》第一次修订 根据2022年3月29日《国务院关于修改和废止部分行政法规的决定》第二次修订)
(Promulgated by Decree No. 149 of the State Council of the People's Republic of China on February 26, 1994; first revision in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on February 6, 2016; second revision in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on March 29, 2022)
总 则
General Provisions
为了加强对医疗机构的管理，促进医疗卫生事业的发展，保障公民健康，制定本条例。
These Regulations are formulated to strengthen the management of medical institutions, promote the development of medical and health services, and protect the health of citizens.
本条例适用于从事疾病诊断、治疗活动的医院、卫生院、疗养院、门诊部、诊所、卫生所(室)以及急救站等医疗机构。
These Regulations apply to medical institutions such as hospitals, health centers, sanatoriums, outpatient departments, clinics, health stations (rooms), and emergency stations that engage in disease diagnosis and treatment activities.
医疗机构以救死扶伤，防病治病，为公民的健康服务为宗旨。
Medical institutions aim to heal the wounded and rescue the dying, prevent and treat diseases, and serve the health of citizens.
国家扶持医疗机构的发展，鼓励多种形式兴办医疗机构。
The State supports the development of medical institutions and encourages the establishment of medical institutions in various forms.
国务院卫生行政部门负责全国医疗机构的监督管理工作。
The health administrative department of the State Council is responsible for the supervision and management of medical institutions nationwide.
县级以上地方人民政府卫生行政部门负责本行政区域内医疗机构的监督管理工作。
The health administrative departments of local people's governments at or above the county level are responsible for the supervision and management of medical institutions within their respective administrative regions.
中国人民解放军卫生主管部门依照本条例和国家有关规定，对军队的医疗机构实施监督管理。
The health authorities of the People's Liberation Army shall, in accordance with these Regulations and relevant state provisions, supervise and manage military medical institutions.
规划布局和设置审批
Planning, Layout, and Establishment Approval
县级以上地方人民政府卫生行政部门应当根据本行政区域内的人口、医疗资源、医疗需求和现有医疗机构的分布状况，制定本行政区域医疗机构设置规划。
The health administrative departments of local people's governments at or above the county level shall formulate plans for the establishment of medical institutions within their administrative regions based on the population, medical resources, medical needs, and the distribution of existing medical institutions.
机关、企业和事业单位可以根据需要设置医疗机构，并纳入当地医疗机构的设置规划。
State organs, enterprises, and institutions may establish medical institutions as needed, and such establishments shall be incorporated into the local plan for the establishment of medical institutions.
县级以上地方人民政府应当把医疗机构设置规划纳入当地的区域卫生发展规划和城乡建设发展总体规划。
Local people's governments at or above the county level shall incorporate the plan for the establishment of medical institutions into the local regional health development plan and the overall plan for urban and rural construction and development.
设置医疗机构应当符合医疗机构设置规划和医疗机构基本标准。
The establishment of a medical institution shall comply with the plan for the establishment of medical institutions and the basic standards for medical institutions.
医疗机构基本标准由国务院卫生行政部门制定。
The basic standards for medical institutions shall be formulated by the health administrative department of the State Council.
单位或者个人设置医疗机构，按照国务院的规定应当办理设置医疗机构批准书的，应当经县级以上地方人民政府卫生行政部门审查批准，并取得设置医疗机构批准书。
Where a unit or individual establishes a medical institution and is required to obtain an approval certificate for the establishment of a medical institution in accordance with the provisions of the State Council, it shall 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 certificate for the establishment of a medical institution.
申请设置医疗机构，应当提交下列文件：
An application for the establishment of a medical institution shall submit the following documents:
(一)设置申请书；
(1) A written application for establishment;
(二)设置可行性研究报告；
(2) A feasibility study report for establishment;
(三)选址报告和建筑设计平面图。
(3) A site selection report and architectural design floor plan.
单位或者个人设置医疗机构，应当按照以下规定提出设置申请：
A unit or individual establishing a medical institution shall submit an application for establishment in accordance with the following provisions:
(一)不设床位或者床位不满100张的医疗机构，向所在地的县级人民政府卫生行政部门申请；
(1) For a medical institution with no beds or fewer than 100 beds, the application shall be submitted to the health administrative department of the county people's government at the place where it is located;
(二)床位在100张以上的医疗机构和专科医院按照省级人民政府卫生行政部门的规定申请。
(2) For a medical institution with 100 or more beds and specialized hospitals, the application shall be submitted in accordance with the provisions of the health administrative department of the provincial people's government.
县级以上地方人民政府卫生行政部门应当自受理设置申请之日起30日内，作出批准或者不批准的书面答复；批准设置的，发给设置医疗机构批准书。
The health administrative department of the local people's government at or above the county level shall, within 30 days from the date of accepting the application for establishment, make a written reply of approval or disapproval; if approval is granted, it shall issue an approval certificate for the establishment of a medical institution.
国家统一规划的医疗机构的设置，由国务院卫生行政部门决定。
The establishment of medical institutions that are uniformly planned by the State shall be decided by the health administrative department of the State Council.
登 记
Registration
医疗机构执业，必须进行登记，领取《医疗机构执业许可证》；诊所按照国务院卫生行政部门的规定向所在地的县级人民政府卫生行政部门备案后，可以执业。
A medical institution must register and obtain the Medical Institution Practice License before practicing; a clinic may practice after filing with the local county-level people's government health administrative department in accordance with the regulations of the State Council health administrative department.
申请医疗机构执业登记，应当具备下列条件：
To apply for medical institution practice registration, the following conditions must be met:
(一) 按照规定应当办理设置医疗机构批准书的，已取得设置医疗机构批准书；
(1) If a medical institution establishment approval document is required, such document has been obtained;
(二)符合医疗机构的基本标准；
(2) Meet the basic standards for medical institutions;
(三)有适合的名称、组织机构和场所；
(3) Have an appropriate name, organizational structure, and premises;
(四)有与其开展的业务相适应的经费、设施、设备和专业卫生技术人员；
(4) Have funds, facilities, equipment, and professional health technical personnel commensurate with the business to be carried out;
(五)有相应的规章制度；
(5) Have corresponding rules and regulations;
(六)能够独立承担民事责任。
(6) Be able to independently bear civil liability.
医疗机构的执业登记，由批准其设置的人民政府卫生行政部门办理；不需要办理设置医疗机构批准书的医疗机构的执业登记，由所在地的县级以上地方人民政府卫生行政部门办理。
The practice registration of a medical institution shall be handled by the health administrative department of the people's government that approved its establishment; for medical institutions that do not require an establishment approval document, the practice registration shall be handled by the health administrative department of the local county-level or above people's government.
按照本条例第十三条规定设置的医疗机构的执业登记，由所在地的省、自治区、直辖市人民政府卫生行政部门办理。
The practice registration of medical institutions established in accordance with Article 13 of these Regulations 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 where it is located.
机关、企业和事业单位设置的为内部职工服务的门诊部、卫生所（室）、诊所的执业登记或者备案，由所在地的县级人民政府卫生行政部门办理。
The practice registration or filing of outpatient departments, health centers (rooms), and clinics set up by government agencies, enterprises, and institutions for internal staff services shall be handled by the health administrative department of the local county-level people's government.
医疗机构执业登记的主要事项：
The main items for medical institution practice registration are:
(一)名称、地址、主要负责人；
(1) Name, address, and principal responsible person;
(二)所有制形式；
(2) Form of ownership;
(三)诊疗科目、床位；
(3) Diagnosis and treatment subjects and beds;
(四)注册资金。
(4) Registered capital.
县级以上地方人民政府卫生行政部门自受理执业登记申请之日起45日内，根据本条例和医疗机构基本标准进行审核。审核合格的，予以登记，发给《医疗机构执业许可证》；审核不合格的，将审核结果以书面形式通知申请人。
The health administrative department of the local county-level or above people's government shall, within 45 days from the date of accepting the practice registration application, conduct a review based on these Regulations and the basic standards for medical institutions. If the review is passed, registration shall be granted and the Medical Institution Practice License issued; if the review fails, the review result shall be notified to the applicant in writing.
医疗机构改变名称、场所、主要负责人、诊疗科目、床位，必须向原登记机关办理变更登记或者向原备案机关备案。
If a medical institution changes its name, premises, principal responsible person, diagnosis and treatment subjects, or beds, it must apply for change registration with the original registration authority or file with the original filing authority.
医疗机构歇业，必须向原登记机关办理注销登记或者向原备案机关备案。经登记机关核准后，收缴《医疗机构执业许可证》。
If a medical institution ceases operation, it must apply for cancellation of registration with the original registration authority or file with the original filing authority. After approval by the registration authority, the Medical Institution Practice License shall be confiscated.
医疗机构非因改建、扩建、迁建原因停业超过1年的，视为歇业。
If a medical institution ceases operation for more than one year for reasons other than renovation, expansion, or relocation, it shall be deemed as having ceased operation.
床位不满100张的医疗机构，其《医疗机构执业许可证》每年校验1次；床位在100张以上的医疗机构，其《医疗机构执业许可证》每3年校验1次。校验由原登记机关办理。
For medical institutions with fewer than 100 beds, the Medical Institution Practice License shall be verified once a year; for medical institutions with 100 or more beds, the Medical Institution Practice License shall be verified once every three years. The verification shall be handled by the original registration authority.
《医疗机构执业许可证》不得伪造、涂改、出卖、转让、出借。
The Medical Institution Practice License shall not be forged, altered, sold, transferred, or lent.
《医疗机构执业许可证》遗失的，应当及时申明，并向原登记机关申请补发。
If the Medical Institution Practice License is lost, it shall be promptly declared and an application for reissuance shall be made to the original registration authority.
执 业
Practice
任何单位或者个人，未取得《医疗机构执业许可证》或者未经备案，不得开展诊疗活动。
No unit or individual may carry out diagnosis and treatment activities without obtaining a Medical Institution Practice License or without filing for the record.
医疗机构执业，必须遵守有关法律、法规和医疗技术规范。
Medical institutions must comply with relevant laws, regulations, and medical technical standards when practicing.
医疗机构必须将《医疗机构执业许可证》、诊疗科目、诊疗时间和收费标准悬挂于明显处所。
Medical institutions must display the Medical Institution Practice License, diagnosis and treatment subjects, consultation hours, and fee standards in a conspicuous place.
医疗机构必须按照核准登记或者备案的诊疗科目开展诊疗活动。
Medical institutions must carry out diagnosis and treatment activities in accordance with the approved or filed diagnosis and treatment subjects.
医疗机构不得使用非卫生技术人员从事医疗卫生技术工作。
Medical institutions may not employ non-health technical personnel to engage in medical and health technical work.
医疗机构应当加强对医务人员的医德教育。
Medical institutions shall strengthen medical ethics education for medical personnel.
医疗机构工作人员上岗工作，必须佩带载有本人姓名、职务或者职称的标牌。
Medical institution staff must wear name tags bearing their name, position, or professional title when on duty.
医疗机构对危重病人应当立即抢救。对限于设备或者技术条件不能诊治的病人，应当及时转诊。
Medical institutions shall immediately rescue critically ill patients. For patients who cannot be diagnosed or treated due to limited equipment or technical conditions, they shall promptly refer them to another facility.
未经医师(士)亲自诊查病人，医疗机构不得出具疾病诊断书、健康证明书或者死亡证明书等证明文件；未经医师(士)、助产人员亲自接产，医疗机构不得出具出生证明书或者死产报告书。
Without a physician personally examining the patient, a medical institution may not issue certificates such as disease diagnosis certificates, health certificates, or death certificates; without a physician or midwife personally delivering the baby, a medical institution may not issue birth certificates or stillbirth reports.
医务人员在诊疗活动中应当向患者说明病情和医疗措施。需要实施手术、特殊检查、特殊治疗的，医务人员应当及时向患者具体说明医疗风险、替代医疗方案等情况，并取得其明确同意；不能或者不宜向患者说明的，应当向患者的近亲属说明，并取得其明确同意。因抢救生命垂危的患者等紧急情况，不能取得患者或者其近亲属意见的，经医疗机构负责人或者授权的负责人批准，可以立即实施相应的医疗措施。
Medical personnel shall explain the patient's condition and medical measures during diagnosis and treatment activities. When surgery, special examinations, or special treatments are needed, medical personnel shall promptly explain the medical risks, alternative treatment plans, etc., to the patient and obtain their explicit consent; if it is impossible or inappropriate to explain to the patient, they shall explain to the patient's close relatives and obtain their explicit consent. In emergency situations such as rescuing a patient in critical condition, if the consent of the patient or their close relatives cannot be obtained, with the approval of the person in charge of the medical institution or an authorized person, the corresponding medical measures may be implemented immediately.
医疗机构发生医疗事故，按照国家有关规定处理。
Medical accidents occurring in medical institutions shall be handled in accordance with relevant state regulations.
医疗机构对传染病、精神病、职业病等患者的特殊诊治和处理，应当按照国家有关法律、法规的规定办理。
Medical institutions shall handle special diagnosis, treatment, and management of patients with infectious diseases, mental illnesses, occupational diseases, etc., in accordance with relevant national laws and regulations.
医疗机构必须按照有关药品管理的法律、法规，加强药品管理。
Medical institutions must strengthen drug management in accordance with laws and regulations on drug administration.
医疗机构必须按照人民政府或者物价部门的有关规定收取医疗费用，详列细项，并出具收据。
Medical institutions must charge medical fees in accordance with relevant regulations of the people's government or price departments, itemize details, and issue receipts.
医疗机构必须承担相应的预防保健工作，承担县级以上人民政府卫生行政部门委托的支援农村、指导基层医疗卫生工作等任务。
Medical institutions must undertake corresponding preventive health care work and tasks assigned by the health administrative department of the people's government at or above the county level, such as supporting rural areas and guiding primary medical and health work.
发生重大灾害、事故、疾病流行或者其他意外情况时，医疗机构及其卫生技术人员必须服从县级以上人民政府卫生行政部门的调遣。
In the event of major disasters, accidents, disease epidemics, or other emergencies, medical institutions and their health technical personnel must obey the dispatch of the health administrative department of the people's government at or above the county level.
监督管理
Supervision and Administration
县级以上人民政府卫生行政部门行使下列监督管理职权：
The health administrative department of the people's government at or above the county level exercises the following supervisory and administrative powers:
(一)负责医疗机构的设置审批、执业登记、备案和校验；
(1) Responsible for the approval of establishment, practice registration, filing, and verification of medical institutions;
(二)对医疗机构的执业活动进行检查指导；
(2) Inspect and guide the practice activities of medical institutions;
(三)负责组织对医疗机构的评审；
(3) Responsible for organizing the evaluation of medical institutions;
(四)对违反本条例的行为给予处罚。
(4) Impose penalties for violations of these regulations.
国家实行医疗机构评审制度，由专家组成的评审委员会按照医疗机构评审办法和评审标准，对医疗机构的执业活动、医疗服务质量等进行综合评价。
The state implements a medical institution evaluation system. An evaluation committee composed of experts shall conduct a comprehensive evaluation of the practice activities and medical service quality of medical institutions in accordance with the medical institution evaluation methods and standards.
医疗机构评审办法和评审标准由国务院卫生行政部门制定。
The medical institution evaluation methods and standards shall be formulated by the health administrative department of the State Council.
县级以上地方人民政府卫生行政部门负责组织本行政区域医疗机构评审委员会。
The health administrative department of the local people's government at or above the county level shall be responsible for organizing the medical institution evaluation committee within its administrative region.
医疗机构评审委员会由医院管理、医学教育、医疗、医技、护理和财务等有关专家组成。评审委员会成员由县级以上地方人民政府卫生行政部门聘任。
The medical institution evaluation committee shall be composed of experts in hospital management, medical education, medical treatment, medical technology, nursing, and finance. 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.
县级以上地方人民政府卫生行政部门根据评审委员会的评审意见，对达到评审标准的医疗机构，发给评审合格证书；对未达到评审标准的医疗机构，提出处理意见。
The health administrative department of the local people's government at or above the county level shall, based on the evaluation opinion of the evaluation committee, issue a certificate of qualification to medical institutions that meet the evaluation standards; for those that do not meet the standards, it shall propose handling opinions.
罚 则
Penalties
违反本条例第二十三条规定，未取得《医疗机构执业许可证》擅自执业的，依照《中华人民共和国基本医疗卫生与健康促进法》的规定予以处罚。
Anyone who, in violation of Article 23 of these Regulations, practices without obtaining a Medical Institution Practice License shall be punished in accordance with the provisions of the Basic Medical and Health Promotion Law of the People's Republic of China.
违反本条例第二十三条规定，诊所未经备案执业的，由县级以上人民政府卫生行政部门责令其改正，没收违法所得，并处3万元以下罚款；拒不改正的，责令其停止执业活动。
Anyone who, in violation of Article 23 of these Regulations, operates a clinic without filing for record shall be ordered by the health administrative department of the local people's government at or above the county level to make corrections, have illegal gains confiscated, and be fined not more than 30,000 yuan; if the clinic refuses to make corrections, it shall be ordered to cease practice activities.
违反本条例第二十一条规定，逾期不校验《医疗机构执业许可证》仍从事诊疗活动的，由县级以上人民政府卫生行政部门责令其限期补办校验手续；拒不校验的，吊销其《医疗机构执业许可证》。
Anyone who, in violation of Article 21 of these Regulations, fails to renew the Medical Institution Practice License within the time limit and still engages in diagnosis and treatment activities shall be ordered by the health administrative department of the local people's government at or above the county level to go through the renewal procedures within a specified period; if the party refuses to renew, the Medical Institution Practice License shall be revoked.
违反本条例第二十二条规定，出卖、转让、出借《医疗机构执业许可证》的，依照《中华人民共和国基本医疗卫生与健康促进法》的规定予以处罚。
Anyone who, in violation of Article 22 of these Regulations, sells, transfers, or lends the Medical Institution Practice License shall be punished in accordance with the provisions of the Basic Medical and Health Promotion Law of the People's Republic of China.
违反本条例第二十六条规定，诊疗活动超出登记或者备案范围的，由县级以上人民政府卫生行政部门予以警告、责令其改正，没收违法所得，并可以根据情节处以1万元以上10万元以下的罚款；情节严重的，吊销其《医疗机构执业许可证》或者责令其停止执业活动。
Anyone who, in violation of Article 26 of these Regulations, engages in diagnosis and treatment activities beyond the registered or filed scope shall be warned and ordered to make corrections by the health administrative department of the local people's government at or above the county level, have illegal gains confiscated, and may be fined not less than 10,000 yuan but not more than 100,000 yuan depending on the circumstances; if the circumstances are serious, the Medical Institution Practice License shall be revoked or the party shall be ordered to cease practice activities.
违反本条例第二十七条规定，使用非卫生技术人员从事医疗卫生技术工作的，由县级以上人民政府卫生行政部门责令其限期改正，并可以处以1万元以上10万元以下的罚款；情节严重的，吊销其《医疗机构执业许可证》或者责令其停止执业活动。
Anyone who, in violation of Article 27 of these Regulations, employs non-health technical personnel to engage in medical and health technical work shall be ordered by the health administrative department of the local people's government at or above the county level to make corrections within a specified period, and may be fined not less than 10,000 yuan but not more than 100,000 yuan; if the circumstances are serious, the Medical Institution Practice License shall be revoked or the party shall be ordered to cease practice activities.
违反本条例第三十一条规定，出具虚假证明文件的，由县级以上人民政府卫生行政部门予以警告；对造成危害后果的，可以处以1万元以上10万元以下的罚款；对直接责任人员由所在单位或者上级机关给予行政处分。
Anyone who, in violation of Article 31 of these Regulations, issues false certification documents shall be warned by the health administrative department of the local people's government at or above the county level; if harmful consequences are caused, a fine of not less than 10,000 yuan but not more than 100,000 yuan may be imposed; the directly responsible person shall be given administrative sanctions by the unit to which he belongs or the superior authority.
没收的财物和罚款全部上交国库。
All confiscated property and fines shall be turned over to the state treasury.
当事人对行政处罚决定不服的，可以依照国家法律、法规的规定申请行政复议或者提起行政诉讼。当事人对罚款及没收药品、器械的处罚决定未在法定期限内申请复议或者提起诉讼又不履行的，县级以上人民政府卫生行政部门可以申请人民法院强制执行。
If a party is dissatisfied with the administrative penalty decision, it may apply for administrative reconsideration or file an administrative lawsuit in accordance with national laws and regulations. If a party fails to apply for reconsideration or file a lawsuit within the statutory time limit for the penalty decision of fines and confiscation of drugs and equipment, and does not comply with the decision, the health administrative department of the local people's government at or above the county level may apply to the people's court for compulsory enforcement.
附 则
Supplementary Provisions
本条例实施前已经执业的医疗机构，应当在条例实施后的6个月内，按照本条例第三章的规定，补办登记手续，领取《医疗机构执业许可证》。
Medical institutions that were already practicing before the implementation of these Regulations shall, within six months after the implementation of these Regulations, go through the registration procedures in accordance with the provisions of Chapter III of these Regulations and obtain the Medical Institution Practice License.
外国人在中华人民共和国境内开设医疗机构及香港、澳门、台湾居民在内地开设医疗机构的管理办法，由国务院卫生行政部门另行制定。
The administrative measures for foreigners to establish medical institutions within the territory of the People's Republic of China and for residents of Hong Kong, Macao, and Taiwan to establish medical institutions in the mainland shall be separately formulated by the health administrative department of the State Council.
本条例自1994年9月1日起施行。1951年政务院批准发布的《医院诊所管理暂行条例》同时废止。
These Regulations shall come into force as of September 1, 1994. The Interim Regulations on the Administration of Hospitals and Clinics approved and issued by the Government Administration Council in 1951 shall be repealed simultaneously.