上海市医疗机构管理办法（2002年修正）
Procedures of Shanghai Municipality on Administration Over Medical Institutions
上海市人民政府令第39号 颁布日期：19970302 实施日期：19970701 颁布单位：上海市人民政府
(Promulgated by Decree No. 39 of the Shanghai Municipal Peoples Government on March 2, 1997)
第一章总则
Chapter I General Provisions
第一条（目的和依据）
Article 1 (Purpose and Basis)
为了加强医疗机构的管理，合理配置医疗资源，促进医疗卫生事业发展，保障公民健康，根据《医疗机构管理条例》的规定，结合本市实际情况，制定本办法。
For the purpose of strengthening the administration of medical institutions, rationally disposing medical resources, promoting the development of medical and public health services and ensuring citizens health; the present Procedures are formulated in accordance with the Regulations on Administration of Medical Institutions and in combination with the actual circumstances in Shanghai.
第二条（医疗机构的含义）
Article 2 (Implication of Medical Institutions) 本办法所称的医疗机构，是指从事医疗执业活动的医院、疗养院、妇幼保健院（所）、疾病防治院（所）、门诊部、诊所、护理院（站）、卫生所（站、室）、医务室、保健所、医疗急救中心（站）、临床检验中心等。
Medical institutions termed in the present Procedures refer to hospitals, sanatorium, women and children care center (station), disease prevention and cure center (station), out-patient department, clinic, nursing center (station), health center (station, post), medical room, health-care station, medical first-aid center (station), clinical laboratory, etc. which are engaged in medical business activities.
前款所称的医院，包括综合医院、中医医院、中西医结合医院、专科医院、康复医院、地段医院、乡（镇）卫生院。
The above mentioned hospitals include general hospital, hospital of traditional Chinese medicine, hospital which combines traditional Chinese medicine with Western medicine, special hospital, convalescence hospital, regional hospital and township (town) health hospital.
第三条（适用范围）
Article 3 (Scope of Application)
本办法适用于本市行政区域内医疗机构的设置、执业许可、医疗执业活动及其监督管理。
The present Procedures are applicable to the supervision and administration of medical institutions as well as their establishment, practice license and medical practising activities in the administrative areas of Shanghai.
第四条（管理部门）市卫生行政部门负责本市医疗机构的监督管理工作。区、县卫生行政部门负责本辖区内医疗机构的监督管理工作。
Article 4 (Administrative Authorities) The Municipal Public Health Administrative Department shall be responsible for the supervision and administration of municipal medical institutions while District (Country) Public Health Administrative Department shall be responsible for the supervision and administration of medical institutions within its jurisdiction.
卫生行政部门设立医疗执业监督员。医疗执业监督员承担医疗机构执业的监督管理工作。
Every public health administrative department shall nominate medical practice supervisors who shall undertake the supervisory and administrative work of medical practice of medical institutions.
公安、工商、规划、计划、物价等行政管理部门应当按照各自职责，协同卫生行政部门做好医疗执业活动的监督管理工作。
The administration departments of public security, of industry and commerce, programming, planning, and price control, and etc. shall help the Public Health Administrative Department to do a good job of supervision and administration over medical practising activities according to their respective duties.
第五条（职业宗旨和法律保护）
Article 5 (Professional Aim and Legal Protection)
医疗执业活动的宗旨是救死扶伤、防病治病，为公民健康提供服务。
The aim of medical practising activities is to heal the wounded and rescue the dying, to prevent and cure diseases and to render services for citizens health.
依法设置医疗机构和从事医疗执业活动，受法律保护。
Medical institutions established according to law and legal medical practising activities are all protected by law.
第六条（许可证制度）
Article 6 (The Practice License System)
本市对医疗机构实行执业许可证制度。
The practice license system is adopted in Shanghai for medical institutions.
未经许可，任何单位和个人不得从事医疗执业活动。
Any unit or individual person shall not be engaged in medical practising activities without getting a practice license.
第七条（医疗机构评审制度）
Article 7 (The Appraisal and Examination System for Medical Institutions)
各级卫生行政部门负责组织专家成立医疗机构评审委员会，评审委员会负责对医疗机构的执业情况进行评审。
Public Health Administrative Department at various levels shall be responsible for organizing experts to set up the appraisal committee for medical institutions. The appraisal committee shall take charge of the appraisal of the practising activities of medical institutions.
评审结论应当作为《医疗机构执业许可证》校验的重要依据之一。
The result of the appraisal shall be one of the important criteria for examining the "Practice License of Medical Institution".
医疗机构评审工作依照《医疗机构评审办法》的有关规定进行。
The appraisal and examination work of medical institutions shall be conducted according to the "Appraisal and Examination Rules for Medical Institutions".
第二章设置审批
Chapter II The Examination & Approval Procedures for the Establishment of Medical Institutions
第八条（设置规划）
Article 8 (The Establishment Planning)
市卫生行政部门应当根据国家医疗机构设置规划的指导原则，结合本市实际情况，编制本市医疗机构设置规划，经市规划管理部门综合平衡后，报市人民政府批准，并由市人民政府将该规划纳入全市卫生发展规划和城市总体规划。
The Municipal Public Health Administrative Department shall, under the guiding principle of the State Program of the Establishment of Medical Institutions and in combination with the actual circumstances in Shanghai, work out the Municipal Program for the Establishment of Medical Institutions which shall, after being comprehensively balanced by the Municipal Program Administrative Department, be submitted to Municipal Peoples Government for approval, and then be incorporated into the Municipal Public Health Development Program and the Overall Urban Development Program.
区、县卫生行政部门应当依据本市医疗机构设置规划和本区、县的实际情况，会同规划管理部门编制本区、县医疗机构设置规划，经市卫生行政部门审核同意后，报区、县人民政府批准，并由区、县人民政府将该规划纳入本区、县卫生发展规划和地区详细规划。
District or County Public Health Administrative Department shall, according to the Municipal Program of the Establishment of Medical Institutions and in combination with its own actual circumstances, together with its Program Department, work out its own Program of the Establishment of Medical Institutions which shall, after being examined, verified, and approved by the Municipal Public Health Administrative Department, be submitted to the District or County Peoples Government for approval, and then be incorporated into the District or County Public Health Development Program and the regional Detailed Program by the District or County Peoples Government.
第九条（设置申请）
Article 9 (Application for Establishment)
设置医疗机构，应当向卫生行政部门提出申请，经卫生行政部门批准后，向其他部门办理有关手续。 For the establishment of a medical institution, an application must be submitted to the Public Health Administrative Department for approval. After being approved, the formalities for establishing the medical institution shall be handled with other authorities.
第十条（设置条件）
Article 10 (Requirements for the Establishment)
申请设置医疗机构，应当具备下列条件：
The application for the establishment of a medical institution shall meet the following requirements:
（一）符合本市医疗机构设置规划；
1. In conformity to the Municipal Program of the Establishment of Medical Institutions;
（二）符合国家规定的医疗机构基本标准；
2. In conformity to the Basic Standards for Medical Institutions stipulated by the State;
（三）有合适的场所；
3. With a suitable premise for establishing the medical institution; and
（四）有必要的资金。
4. With necessary fund.
第十一条（个体诊所、个体护理站的设置条件）
Article 11 (Requirements for the Establishment of a Private Clinic or a Private Nursing Station)
申请设置个体（包括合伙，下同）诊所或者个体护理站，除应当具备本办法第十条第二项至第四项规定的条件外，还应当同时具备下列条件：
In addition to the requirements stipulated in Item 2 of Article 10 to Item 4 of Article 10 in the present Procedures, the applicant for the establishment of a private clinic (including partnership. The same below) or a private nursing station shall also meet the following requirements at the same time:
（一）具有本市常住户口； 1. With permanent residential registration in Shanghai;
（二）根据申请执业范围取得相应的医师或者护士执业资格后，从事同一专业临床工作5年以上；
2. With the professional qualifications as a doctor or nurse in conformity with the practising scope applied for and a clinical experience of five years or more in the same profession; and
（三）非在职人员。
3. Non-in-service employee.
第十二条（申请限制条件）
Article 12 (Restrictive Terms for Application)
不能独立承担民事责任的组织，不得申请设置医疗机构。
Any organization, which is unable to bear civil liability independently, can not apply for the establishment of a medical institution.
有下列情形之一的人员，不得申请设置医疗机构：
No person in any one of the following cases is permitted to apply for the establishment of a medical institution:
（一）无民事行为能力或者限制民事行为能力的人员；
1. The person who is incapable of, or with restricted capacity of, doing a civil act;
（二）正在服刑或者劳动教养的人员；
2. The person who is serving a sentence liability or receiving reeducation through labour;
（三）在职人员；
3. In-service employee;
（四）发生二级以上医疗事故未满5年的直接责任人员；
4. The person who bears direct liability for a medical accident of Class II or above, which has not yet been five years;
（五）被吊销执业证书的医务人员；
5. The medical person whose certificate of practice is revoked;
（六）被吊销《医疗机构执业许可证》未满5年的医疗机构的原法定代表人或者主要负责人；
6. The original legal representative or the principal of a medical institution whose "Practice License of Medical Institution"has been revoked for less than five years;
（七）患传染病未愈或者其他健康原因不宜从事医疗执业活动的人员；
7. The person who is still suffering from an infections disease or other health problem, thus being unsuitable to be engaged in medical practising activities;
（八）被国家机关开除公职或者被医疗机构解除聘用合同未满5年的人员。
or 8. The person who has been dismissed from public office by the State organs or whose employment contract has been discharged by a medical institution for less than five years.
第十三条（申请材料的提交） Article 13 (Application Documents to Be Submitted)
申请设置医疗机构，应当提交下列材料，但申请设置个体诊所或者个体护理站除外：
The following documents shall be submitted on application for the establishment of a medical institution, except for the application for establishing a private clinic or a private nursing station:
（一）设置申请书；
1. An application for establishment;
（二）选址报告和建筑设计平面图；
2. Site selection report and the drawings of architectural design; （三）可行性研究报告；
3. The feasibility study report;
（四）设置申请人的资信证明；
4. The certificate of credit standing and respectability of the establishment applicant; and
（五）设置申请人的基本情况证明。
5. The certificate of the basic condition of the establishment applicant.
第十四条（申请设置个体诊所、个体护理站应当提交的材料）
Article 14 (Application Documents to Be Submitted for the Establishment of A Private Clinic or A Private Nursing Station)
申请设置个体诊所或者个体护理站，应当提交下列材料：
The following documents shall be submitted on application for the establishment of a private clinic or a private nursing station:
（一）设置申请书；
1. An application for establishment;
（二）房屋产权证明或者使用权证明；
2. The certificate of house property right or the certificate of house use rights; and
（三）设置申请人具备本办法第十条规定条件的相关证明。
3. All of the related certificates which fully prove that the establishment applicant meets the requirements stipulated in Article 10 of the present Procedures.
第十五条（医疗机构的分级）
Article 15 (Grading of Medical Institutions) 根据国家医疗机构基本标准的分级规定，本市医院（除康复医院外）、妇幼保健院（所）、疾病防治院（所）分为三级、二级和一级3个等级。
According to the national basic standards for grading medical institutions, hospitals (except convalescence hospital), women and children care center (station), and disease prevention and cure center (station) in Shanghai shall be graded into three grades-Grade III, Grade II and Grade I.
第十六条（设置审批权限）设置下列医疗机构，应当向市卫生行政部门提出申请：
Article 16 (Competence for Examining and Approving the Establishment) For the establishment of the following medical institutions, an application shall be submitted to the Municipal Public Health Administrative Department:
（一）三级医院、二级医院、康复医院；
1. Grade-III hospital, Grade-II hospital and convalescence hospital;
（二）疗养院、妇幼保健院（所）、疾病防治院（所）；
2. Sanatorium, women and children care center (station) and disease prevention and cure center (station);
（三）医疗急救中心（站）；
3. Medical first-aid center (station);
（四）临床检验中心；
4. Clinical laboratory; and
（五）市卫生行政部门规定的其他医疗机构。
5. Other medical institutions stipulated by the Municipal Public Health Administrative Department.
设置下列医疗机构，应当向设置地的区、县卫生行政部门提出申请：
For the establishment of the following medical institutions, an application shall be submitted to the District or County Public Health Administrative Department in the locality where the medical institution will be established:
（一）一级医院；
(1) Grade-I hospital;
（二）门诊部；
(2) Out-patient department;
（三）诊所；
(3) Clinic;
（四）护理院（站）；
(4) Nursing center (station); and
（五）卫生所（站、室）、保健所。
(5) Health center (station, post) and health-care station.
第十七条（设置审批原则和审批程序）
Article 17 (Principle and Procedure for Examining and Approving the Establishment)
卫生行政部门应当根据医疗机构设置规划、国家规定的医疗机构基本标准和本办法的有关规定，审批医疗机构的设置申请。
The Public Health Administrative Department shall, according to the Medical Institutions Establishment Program, the Basic Standard for Medical Institution stipulated by the State, and the related provisions of the present Procedures, examine and approve the application for establishing a medical institution.
卫生行政部门应当自收到医疗机构设置申请人提交的全部材料之日起30日内进行审查。对符合条件的，批准设置并发给《设置医疗机构批准书》；对不符合条件的，应当书面告知设置申请人。
The Public Health Administrative Department shall examine the application within 30 days after receipt of all the materials submitted by the applicant for establishing of a medical institution. The Public Health Administrative Department shall approve and issue an Approval Certificate for the Establishment of Medical Institution to the applicant if the application meets the requirements; or inform the applicant in writing if the application does not meet the requirements.
区、县卫生行政部门在核发《设置医疗机构批准书》之前，应当告知设置申请人向市卫生行政部门申请办理医疗机构名称核准手续，市卫生行政部门应当自收到核准名称的书面申请之日起10日内作出书面答复。核准名称期间，设置审批程序中止。
Before examining and issuing the Approval Certificate for the Establishment of Medical Institution, the District or County Public Health Administrative Department shall inform the applicant of going through the formalities for the Name Ratification of the medical institution with the Municipal Public Health Administrative Department; and the Municipal Public Health Administrative Department shall reply in writing within 10 days after receiving the written application for the Name Ratification. During the Name Ratification period, the procedure of examination and approval of the establishment shall be suspended.
区、县卫生行政部门应当自核发《设置医疗机构批准书》之日起15日内，报市卫生行政部门备案。对区、县卫生行政部门作出的不符合本办法规定的审批决定，市卫生行政部门有权纠正或者撤销。
The District or County Public Health Administrative Department shall submit the Approval Certificate for the Establishment of Medical Institution to the Municipal Public Health Administrative Department for record within 15 days after its issuance. The Municipal Public Health Administrative Department has the right to rectify or cancel the approval decision made by the District or County Public Health Administrative Department which does not conform to the stipulations of the present Procedures.
第十八条（批准书有效期） Article 18 (The Validity Period of the Approval Certificate) 根据医疗机构的不同类别，《设置医疗机构批准书》的有效期限分别如下：
According to the different grades of medical institutions, the validity period of the "Approval Certificate for the Establishment of Medical Institution"shall respectively be as follows:
（一）医院、疗养院、妇幼保健院（所）、疾病防治院（所）、医疗急救中心、临床检验中心为２年；
1. Two years for hospitals, sanatorium, women and children care center (station), disease prevention and cure center (station), medical first-aid center and clinical laboratory;
（二）门诊部、医疗急救站、护理院为１年；
2. One year for outpatient department, medical first-aid station and nursing center; and
（三）诊所、护理站、卫生所（站、室）、保健所为6个月。
3. Six months for clinic, nursing station, health center (station, post), and health-care station.
第十九条（变更、重新设置审批和分支机构的审批）
Article 19 (Procedure for Examining and Approving the Alteration, Re-establishment, and for Examining and Approving the Establishment of Branches)
医疗机构执业登记前，其经核准的名称、诊疗科目发生变更的，应当申请办理变更审批手续。
Before the registration of practice of a medical institution, if the ratified name or medical subjects of diagnosis and treatment are changed, the institution shall apply for examination and approval for the change.
医疗机构执业登记前，其经核准的类别、床位、地点、设置申请人发生变更的，应当重新申请办理设置审批手续。
Before the registration of practice of a medical institution, if the ratified classification, number of sickbeds, address, or the establishment applicant is changed, the institution shall reapply for the establishment examination and approval.
医疗机构设置分支机构的，应当向原设置审批的卫生行政部门申请办理审批手续；
If a medical institution intends to establish a branch, it shall apply for examination and approval with the original Public Health Administrative Department which has examined and approved the establishment of the medical institution.
分支机构不在医疗机构所属的区、县内的，应当征得分支机构所在地的区、县卫生行政部门同意。
If the branch is not established in the district or county where the medical institution is located, the establishment of the branch shall obtain the consent from the District or County Public Health Administrative Department in the locality where the branch shall be established.
第二十条（建筑设计） Article 20 (Architectural Design) 医疗机构的建筑设计，应当符合国家规定的医疗机构建筑规范、医疗机构设计标准以及国家其他有关规定和标准；设计方案、扩初设计经原设置审批的卫生行政部门审查同意，并取得规划部门核发的《建设工程规划许可证》后，方可施工。
The architectural design of medical institutions shall conform to the architectural specification, design standards and other relevant stipulations and standards for medical institutions stipulated by the State. The architectural project of medical institutions shall not be constructed until the design scheme and initial extension design are examined and approved by the original Public Health Administrative Department which has examined and approved the establishment of the medical institution and the "Planning Permit of the Construction Project"is issued by the Planning Department.
第三章执业登记
Chapter III Practice Registration
第二十一条（申请登记手续）
Article 21 (Process of Application for the Registration)
医疗机构从事医疗执业活动前，应当向原设置审批的卫生行政部门申请办理执业登记手续，领取《医疗机构执业许可证》。
Before being engaged in medical practising activities, a medical institution shall apply to the original Public Health Administrative Department which has examined and approved the establishment of the medical institution for the practice registration, and obtain the "Practice License of Medical Institution".
第二十二条（申请登记的条件）医疗机构申请办理执业登记手续，应当具备下列条件：
Article 22 (Requirements for the Registration Application) A medical institution shall meet the following requirements on application for the practice registration:
（一）有《设置医疗机构批准书》；
1. With the "Approval Certificate for the Establishment of Medical Institution";
（二）符合国家规定的医疗机构基本标准；
2. In conformity to the Basic Standards for Medical Institutions stipulated by the State;
（三）有符合规定的组织机构；
3. With an organizational structure conforming to the related stipulations;
（四）有与所开展的业务相适应并符合规定的资金、仪器设备、卫生技术人员以及通讯、供电、上下水道等必要设施；
4. With necessary fund, instruments and equipments, medical technical personnel and necessary facilities for communication, power supply, water supply and sewers, etc. to carry out its practice as well as to meet the prescribed requirements;
（五）有相应的规章制度；
5. With relevant rules and regulations; and
（六）能够独立承担民事责任。
6. Capable of undertaking civil liability independently.
第二十三条（申请登记应当提交的材料）
Article 23 (Materials to be Submitted with the Application for Registration)
医疗机构申请办理执业登记手续，应当提交下列材料：
A medical institution shall submit the following materials on application for the practice registration:
（一）《医疗机构申请执业登记注册书》；
1. "The Practice Registration Application for the Medical Institution";
（二）《设置医疗机构批准书》；
2. "The Approval Certificate for the Establishment of Medical Institution";
（三）房屋产权证明或者使用证明；
3. The certificate of house property right or the certificate of house use right;
（四）验资证明；
4. The fund verification certificate;
（五）医疗机构建筑设计平面图；
5. The drawing of the architectural design of the medical institution;
（六）医疗机构规章制度；
6. The rules and regulations of the medical institution; and
（七）医疗机构法定代表人或者主要负责人姓名及其资格证书或者执业证书。
7. The name and certificate of qualification or certificate of practice of the legal representative or the principal person in charge of the medical institution.
除前款规定外，新建、改建或者扩建的医疗机构，应当提交竣工验收的批准文件；
In addition to the above stipulations, the newly built or rebuilt or extended medical institution shall also submit the approval document of the project completion inspection.
共同设置的医疗机构，应当提交有关合同书或者协议书；诊所、护理站、卫生所（站、室）和保健所，应当提交卫生技术人员名单及其资格证书或者执业证书。
For the jointly established medical institution, the relevant contract or agreement shall be submitted. For a clinic, nursing station, health center (station, post) or healthcare station, it shall also submit the list of medical technical personnel and their certificates of qualification or their certificates of practice.
第二十四条（执业登记的审批） Article 24 (Examination and Approval of the Practice Registration) 卫生行政部门应当自收到医疗机构执业登记申请人提交的全部材料之日起45日内进行审查核实。
The Public Health Administrative Department shall examine and verify the application for the practice registration within 45 days after receipt of all the materials submitted by the applicant for practice registration of the medical institution.
对符合条件的，予以登记并发给《医疗机构执业许可证》；对不符合条件的，应当书面告知执业登记申请人。
The Administrative Department shall approve the registration and issue the "Practice License of Medical Institution", if the application meets the requirements; if not, the Administrative Department shall inform the practice registration applicant in writing.
第二十五条（变更登记）
Article 25 (Alteration Registration)
医疗机构执业登记后，其经核准的名称、法定代表人或者主要负责人、诊疗科目、床位、类别、级别、地点、服务方式、服务对象发生变更的，应当向原执业登记的卫生行政部门申请办理变更登记手续。
After the practice registration of a medical institution, if the ratified name, the legal representative or the principal person in charge, medical subjects of diagnosis and treatment, number of sickbeds, classification, grade, address, mode of service or service target is changed, the medical institution shall apply for the alteration registration with the original Public Health Administrative Department which has approved its practice registration.
第二十六条（许可证校验的间隔期限）
Article 26 (The Prescribed Intervals for Examination of Practice License)
《医疗机构执业许可证》应当按照规定的间隔期限进行校验：
The "Practice License of Medical Institution"shall be examined at the prescribed intervals:
（一）医院、疗养院、妇幼保健院（所）、疾病防治院（所）、医疗急救中心、临床检验中心每３年校验1次；
1. Once every three years for hospitals, sanatorium, women and children care center (station), disease prevention and cure center (station), medical first aid center and clinical laboratory; and
（二）门诊部、医疗急救站、护理院（站）、诊所、卫生所（站、室）、保健所每年校验1次。
2. Once every year for the outpatient department, medical first aid station, nursing center (station), clinic, health center (station, post) and healthcare station.
第二十七条（许可证的校验）
Article 27 (Examination of Practice License)
医疗机构应当在校验间隔期满前３个月内，持《医疗机构执业许可证》正、副本和上一年度卫生行政部门检查考核结果或者医疗机构评审委员会的评审结论，向原执业登记的卫生行政部门申请办理《医疗机构执业许可证》校验手续。
A medical institution shall apply to the original Public Health Administrative Department, which has approved the practice registration, for handling the examination procedures for the "Practice License of Medical Institution” three months before the expiration of the examination interval by presenting the original and copy of the "Practice License of Medical Institution"and the inspection and assessment results for the previous year issued by the Public Health Administrative Department or the appraisal conclusion issued by the Appraisal Committee for Medical Institutions.
卫生行政部门应当自收到医疗机构申请校验的全部材料之日起30日内完成校验；
The Public Health Administrative Department shall finish the examination within 30 days after receipt of all the documents submitted by the medical institution for the examination application.
对未通过校验的，应当注销其《医疗机构执业许可证》。
In case the medical institution does not pass the examination, its "Practice License of Medical Institution"shall be revoked.
第二十八条（登记名册上报）
Article 28 (Reporting of the Registration Name List)
区、县卫生行政部门应当于每年1月底前，将上年度本区、县内登记执业的医疗机构名册上报市卫生行政部门。
District or County Public Health Administrative Department shall report the practice registration name list of medical institutions in this District or County for the previous year to the Municipal Public Health Administrative Department by the end of January every year.
第二十九条（停止执业活动的规定）
Article 29 (Stipulations for Terminating or Suspending the Practising Activities)
医疗机构终止医疗执业活动的，应当向原执业登记的卫生行政部门办理《医疗机构执业许可证》注销手续。
A medical institution which terminates its medical practising activities shall go through the cancellation procedures for the "Practice License of Medical Institution"with the original public health administrative department which has approved its practice registration.
其中地段医院、乡（镇）卫生院撤销或者合并，应当经市卫生行政部门核准后，方可办理注销手续。
In the event of the cancellation or merger of a regional hospital or a township (town) health hospital, the cancellation procedures shall not be handled until the cancellation is ratified by the Municipal Public Health Administrative Department.
医疗机构因扩建、改建等原因，暂时歇业或者部分歇业的，应当事先向原执业登记的卫生行政部门办理歇业手续。
If a medical institution intends to suspend its practice temporarily or partly due to extension, or reconstruction, or other causes, it shall apply for the practice suspension procedures in advance with the original Public Health Administrative Department which has approved its practice registration.
第三十条（有关许可证的禁止行为）
Article 30 (Forbidden Acts Relating to the Practice License)
《医疗机构执业许可证》由国家卫生行政部门统一印制，任何单位或者个人不得伪造、涂改、出租、出借或者转让。
The "Practice License of Medical Institution"is unifiedly printed by the State Public Health Administrative Department, any unit or individual person shall not forge, alter, lease, lend or transfer it.
第四章执业管理
Chapter IV Administration of Practice
第三十一条（执业范围）
Article 31 (Scope of Practice)
医疗机构的医疗执业活动，应当在《医疗机构执业许可证》规定的范围内进行。
The medical practising activities of a medical institution shall be performed within the scope of practice specified in the "Practice License of Medical Institution".
第三十二条（执业原则）医疗机构从事医疗执业活动，必须遵守有关法律、法规、规章和医疗技术规范、职业道德规范。
Article 32 (Principle of Practice) Medical institutions, which are engaged in medical practising activities, shall abide by relevant laws, rules and regulations as well as medical technical specification and norms for professional ethics.
医疗机构应当按照国家和本市的医疗质量控制要求，执行各项规章制度和各级各类人员岗位责任制，加强医疗质量管理，确保医疗安全和服务质量。
Medical institutions shall carry out all rules and regulations, exercise the post responsibility system for various medical persons at all levels, strengthen medical quality control and ensure medical safety and the quality of services according to the State and Municipal medical quality control requirement.
第三十三条（医疗机构名称的使用）
Article 33 (Use of the Name of a Medical Institution)
医疗机构从事医疗执业活动，应当使用市卫生行政部门核准的名称。
A medical institution engaged in medical practising activities shall use the name ratified by the Municipal Public Health Administrative Department.
医疗机构印章、银行帐户、牌匾、票据、药品分装袋、制剂标签以及病历卡、处方笺、检查申请单、检查报告单、检查证明书、疾病证明、出生证明或者死亡证明等医疗文件中使用的医疗机构名称，应当与核准的名称相同；核准的名称有两个以上的，应当使用第一名称。
The name of a medical institution to be used in the seal of a medical institution, its bank account, signboard, bills, medicine bags, labels for pharmaceutical preparations, medical record card, prescription pad, examination application, examination report, and in medical documents such as certificate of health examination, certificate of disease, birth certificate, death certificate, etc. shall be identical with the ratified name. If there are two or more ratified names, the first name shall be used.
任何单位或者个人不得买卖、出借、转让或者冒用标有医疗机构名称的票据、药品分装袋、制剂标签以及病历卡、处方笺、检查申请单、检查报告单、检查证明书、疾病证明、出生证明或者死亡证明等医疗文件。
Any unit or individual person shall not buy, sell, transfer or fraudulently use the bills, medicine bags, labels for pharmaceutical preparations, and medical documents such as medical record card, prescription pad, examination application, examination report, certificate of health examination, certificate of disease, birth certificate, death certificate, etc.
医疗机构冠名管理规定，由市卫生行政部门另行制定。
The regulations on the name using control of medical institutions shall be separately formulated by the Municipal Public Health Administrative Department.
第三十四条（明示制度）
Article 34 (The Display System)
医疗机构应当将《医疗机构执业许可证》、诊疗科目、诊疗时间、诊疗科室分布示意图和收费标准置于明显位置。
A medical institution shall display the "Practice License of Medical Institution", medical subjects of diagnosis and treatment, service timetable, layout of medical departments and service charge list in the conspicuous places.
医疗机构应当实行工作人员佩带载有本人工号、职务的标牌上岗的制度。
A medical institution shall exercise the system that every worker, when working at his/her post shall bear an identification card marked with his/her work number and job.
第三十五条（门诊、急诊、住院诊疗制度）
Article 35 (The System of Ambulatory Treatment, Emergency Treatment and Hospitalization)
医疗机构应当根据经核准的服务方式，执行门诊、急诊、住院的有关诊疗制度，开展医疗执业活动。
A medical institution shall, according to the ratified mode of services, execute the relevant system of ambulatory treatment, emergency treatment and hospitalization, and carry out the medical practising activities.
医疗机构对同一医师三次门诊不能确诊的病人，应当安排上一级医师复诊；
If no exact diagnosis can be made by the same doctor for three times under ambulatory treatment, the medical institution shall arrange for the patient to further consult a doctor of higher rank.
经复诊仍不能确诊的，应当组织会诊或者安排转诊。
In case the disease still cannot be exactly diagnosed through further consultation, a group consultation shall be organized or the patient shall be transferred to other hospital for further diagnosis.
设立住院病床的医疗机构，对住院病人、急诊留院观察病人应当安排固定的医师负责诊疗，并实行上一级医师查房和分级护理责任制，严格执行值班、交接班等制度；对不能确诊的病人，医疗机构应当组织会诊或者安排转诊。
A medical institution with sickbeds shall have regular doctors to take charge of diagnosing and treating diseases of inpatients and emergency patients staying for observation, carry out the system of wardtouring by doctors of higher rank and the nursing responsibility system at different levels, and strictly execute the onduty system and the shiftrotating system. For a patient whose disease cannot be exactly diagnosed, the medical institution shall organize, or transfer the patient to other hospitals, for further diagnosis.
设立急诊的医疗机构，应当实行24小时应诊制度。
A medical institution with an emergency room shall practise the round-the-clock reception system.
第三十六条（危重病人的处理）
Article 36 (Treatment of Patients in Serious Case)
医疗机构对危重病人应当立即组织抢救，并视情况及时向病人家属发出病危通知书，无病人家属或者无法通知病人家属的，应当向病人所属单位发出病危通知书。
A medical institution shall organize emergency treatment at once to the patient who is seriously ill, and according to the development of the case issue a notice of critical illness to the patient''s family member in time; or to the patient''s unit if the patient has no family member or it is impossible to notify the patient''s family member.
医疗机构对限于接诊医师（士）技术水平不能诊治的危重病人，应当及时安排上一级医师诊治；
If the reception doctor is unable to diagnose and treat a patient in critical illness due to his/her limited technical level, the medical institution shall assign a doctor of higher rank in time to diagnose and treat the patient.
对接诊科室不能诊治的危重病人，应当及时组织会诊。
If the reception department is unable to diagnose and treat a patient in critical illness, the medical institution shall organize a group consultation in time.
医疗机构对限于设备或者技术条件不能诊治的危重病人，应当及时组织会诊或者在落实接诊医疗机构后，由医务人员护送及时转诊；
If the critical illness of a patient cannot be diagnosed and treated due to the limited medical apparatus or technical conditions, the medical institution shall organize a group consultation in time or transfer the patient to other medical institution escorted by medical personnel through arrangements for further diagnosis and treatment in time.
对可能在转诊途中死亡的病人，不得转诊。
But no such transfer shall be made, if the patient may die on the way.
第三十七条（施行特殊诊疗的前置条件）
Article 37 (Preconditions for Performing Special Diagnosis and Treatment)
医疗机构施行手术、特殊检查、输血或者特殊治疗时，应当征得病人同意，并取得病人家属或者关系人同意并签字；
When a medical institution intends to perform a surgical operation, special examination, blood transfusion or special treatment; it shall obtain the consent from the patient as well as the consent and signature of his/her family member or relative.
无法取得病人意见或者因实施保护性医疗措施不宜向病人说明情况的，应当取得病人家属或者关系人同意并签字；
In the event that the patient''s opinion can not be obtained, or it is unadvisable to tell the patient the truth due to the adopting of a protective medical measure, it is necessary to obtain the consent and signature of his/her family member or relative.
无法取得病人意见又无病人家属或者关系人在场，或者遇到其他特殊情况的，经治医师应当提出医疗处置方案，在取得医疗机构负责人或者被授权负责人员的批准后方可施行。
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.
第三十八条（医源性感染的控制）
Article 38 (Control of Iatrogenic Infection)
医疗机构应当严格执行传染病报告、无菌消毒和隔离制度，并采取有效措施处理污水和废弃物，预防和控制医源性感染。
A medical institution shall strictly execute the systems of report on infectious diseases, of aseptic disinfecting and of isolation. Simultaneously, it shall adopt effective measures to dispose of sewage and wastes, and to prevent and control pathogenic infection.
第三十九条（病历管理）
Article 39 (Control of Medical Record Cards)
医疗机构对门诊、急诊和住院病人的病历的记录，应当及时、准确、完整、清晰，不得擅自涂改和毁损病历卡；但国家或者市卫生行政部门规定可以修改的除外。
A medical institution shall record the ambulatory treatment, emergency treatment and hospitalization of patients timely, accurately, completely and clearly, and shall not alter, damage or destroy medical record cards with the exception that such amendment is permitted according to stipulations made by State or the Municipal Public Health Administrative Department.
任何单位或者个人未经医疗机构许可，不得私自翻阅、索要病历卡，不得涂改和毁损病历卡。
Any unit or individual person shall not read or ask for a medical record card without permission of the medical institution; and shall not alter, damage or destroy a medical record card.
医疗机构应当妥善地保管病人的病历卡。
A medical institution shall properly keep the medical record cards of patients.
门诊病历卡的保存期不得少于15年，但按规定由病人自管的除外；
The storage period of medical record cards of outpatients shall not be less than fifteen years, except those self kept by patients themselves as stipulated.
急诊留观病历卡的保存期不得少于1年；住院病历卡的保存期不得少于30年。
The storage period of medical record cards of emergency patients staying for observation shall not be less than one year. And the storage period of medical record cards of inpatients shall not be less than thirty years.
第四十条（医疗证明文件的出具）
Article 40 (Issuance of Medical Certificates)
未经本机构医师（士）诊查，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文件；未经本机构医师（士）、助产人员接产，医疗机构不得出具出生证明书或者死产报告书。
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 of the medical institution. Likewise, it shall not issue a birth certificate or a dead birth report, if no obstetrician or midwife of the medical institution has delivered the baby.
医疗机构对非经治的死亡原因不明者出具死亡证明书，只证明其已死亡，不作死亡原因的诊断。
In the event that a medical institution issues a death certificate to a person who has died of an unknown cause without being treated in the medical institution, the certificate only certifies the death but not any diagnosis upon the cause of the death.
有关方面要求进行死亡原因诊断的，医疗机构应当指派医师进行尸体解剖及实验室检查后，方能作出死亡原因诊断。
In the event that the party concerned demands a diagnosis upon the cause of death, the medical instruction shall appoint doctors to perform the autopsy and laboratory tests; and then a diagnosis of the death cause can be made.
第四十一条（保护性医疗措施）
Article 41 (Protective Medical Measure)
医疗机构应当尊重病人对自己所患疾病的知情权利，因实施保护性医疗措施不宜直接告知病人的，应当将有关情况告知病人家属，无病人家属或者无法通知病人家属的，应当告知病人所属单位。
A medical institution shall respect the patient''s right to know the truth of his/her disease. However, when it is unadvisable to directly tell a patient the truth of his/her disease because protective medical measure is taken, the medical institution shall inform his/her family member of the truth, or inform his/her unit if the patient has no family or if his/her family member is not available.
第四十二条（医疗纠纷报告制度）
Article 42 (The Report System for Medical Disputes)
医疗机构发生医疗事故或者重大医疗纠纷，应当立即向上级主管部门及市卫生行政部门报告，并妥善保存有关病历卡和资料，不得涂改、伪造、隐藏、销毁有关病历卡和资料；
In case that any medical accident or major medical dispute occurs, the medical institution shall promptly report it to the higher competent department and the Municipal Public Health Administrative Department. Simultaneously, it shall properly keep the relevant medical record cards and data, which shall not be altered, forged, hidden or destroyed.
因注射、服药、输液、输血以及使用器械引起不良后果的，应当暂时封存有关实物，以备查验。
All the things, which have caused harmful consequences through injection, medicine-taking, infusion of fluid, blood transfusion and use of apparatus, shall be sealed up for safekeeping temporarily for on-the-spot examination.
第四十三条（医疗执业活动的限制）
Article 43 (Restrictions on Medical Practising Activities)
未经市卫生行政部门批准，非医疗机构不得组织医务人员开展医疗执业活动。
Non-medical institution shall not organize medical persons to carry out medical practising activities without approval by the Municipal Public Health Administrative Department.
医疗机构在本机构以外的场所组织卫生技术人员开展医疗执业活动，应当经卫生行政部门批准。
If a medical institution intends to organize public health technical persons to carry out medical practising activities in any places outside the institution, it shall obtain approval from the Public Health Administrative Department.
具体管理内容由市卫生行政部门另行制定。
The detailed content of control shall be separately worked out by the Municipal Public Health Administrative Department.
第四十四条（医疗费用）
Article 44 (Medical Fees)
医疗机构收取医疗费用，应当执行市卫生、物价行政部门规定的标准，并出具相应收据。
A medical institution shall charge medical fees according to the standards stipulated by the Municipal Public Health Administrative Department and Price Control Bureau, and shall provide corresponding receipts.
任何单位或者个人不得拒付医疗费用。
Any unit or individual person shall not refuse to pay medical fees.
第四十五条（预防保健等职责）
Article 45 (Duties of Disease Prevention and Health-Care)
医疗机构应当承担相应的预防保健工作，执行市卫生行政部门规定的疾病报告制度，承担本市各级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。
A medical institution shall undertake the corresponding work of disease prevention and healthcare, execute the disease report system stipulated by the Municipal Public Health Administrative Department and fulfill the tasks of aiding the rural areas and instructing the medical and public health work of grass-roots units as entrusted by Public Health Administrative Department at various levels in Shanghai.
发生重大灾害事故、疾病流行或者其他意外情况时，医疗机构及其工作人员应当服从各级卫生行政部门的调遣。
In case any grave disastrous accident, epidemic disease or other unforeseen events occur, a medical institution and its workers shall obey the assignment given by the Public Health Administrative Department at various levels.
第四十六条（禁止或者限制行为）
Article 46 (Forbidden or Restricted Acts)
医疗机构及其工作人员在从事医疗执业活动中，不得有下列情形：
Medical institutions and their workers shall not commit the following offences in their medical practising activities:
（一）借故推诿病人或者以不正当方法招徕病人；
1. Finding an excuse to refuse patients, or soliciting patients by improper means;
（二）单位内部医疗机构未经卫生行政部门批准向社会开放；
2. Opening the internal medical institution of a unit to the public without approval of the Public Health Administrative Department;
（三）聘用非卫生技术人员或者未经注册登记的卫生技术人员从事医疗执业活动；
3. Employing non-public health technical persons or non-registered public health technical persons to carry out medical practising activities;
（四）未经国家或者市卫生行政部门批准，引进国外医学新技术、新项目或者从事婚前医学检查、遗传病诊断、产前诊断、人工授精等母婴保健专项技术服务；
4. Introducing new medical technology and new projects from abroad, or being engaged in such special technical services for mother child healthcare, such as medical examination before marriage, diagnosis on hereditary diseases, prenatal diagnosis, artificial insemination, etc. without approval of the State or Municipal Public Health Administrative Department;
（五）未经区、县卫生行政部门批准，从事中止妊娠术、节育手术或者助产技术等母婴保健专项技术服务；
5. Being engaged in such special technical services for mother-baby health-care as suspension of pregnancy, birth-control operation, midwife technique, etc.
（六）个体诊所和个体护理站聘用在职卫生技术人员或者储备药品；
without approval of District or county Public Health Administrative Department;
（七）利用职业便利收受他人钱物或者获取其他不正当利益；
6. A private clinic or private nursing station employing an in-service public health technical person or storing up medicines;
（八）使用假药、劣药、过期药品、失效药品、淘汰药品；
7. Taking advantages of one''s professional position to accept others'' money or things, or to gain other improper interests;
（九）使用无卫生许可证的消毒药剂、消毒器械或者一次性医疗卫生用品；
8. Using fake, inferior, expired, inefficacious or eliminated medicines;
（十）泄露在医疗执业活动中知悉的病人隐私。
9. Using unlicensed disinfectants, disinfecting apparatus or non-reusable medical and sanitary articles; and 10. Revealing private secrets of a patient known through medical practising activities.
第四十七条（医疗秩序的保障）
Article 47 (Guarantee of Medical Working Order)
任何单位或者个人不得以任何理由或者方式扰乱医疗机构的正常秩序，侵犯医务人员的人身安全或者损毁财物；不得在医疗机构内进行各种形式的迷信祭祀活动；不得干涉、阻碍医疗机构对尸体的常规处置。
Any unit or individual person shall not, with any reason or in any way, disturb the normal order of medical institution, infringe upon personal safety of medical persons, or damage property and things; shall not do superstitious activities or sacrificial rites in any form inside the medical institution; or shall not interfere in or hinder the normal disposal of the corpse by the medical institution.
第四十八条（尸体的处理）
Article 48 (Disposal of the Corpse)
医疗机构应当及时将病人尸体存放停尸室。
A medical institution shall place the corpse of a patient in the mortuary in time.
尸体在停尸室存放的期限，6至9月份不得超过2天，其他月份不得超过3天。
The time limit for the corpse to be stored in the mortuary is not more than 2 days from June through September, and not more than 3 days in any other month.
医疗机构有权要求死者家属在前款规定的尸体存放期限内，将尸体移送殡葬馆火化。
A medical institution has the right to demand that the family member of the deceased must transport the corpse to the funeral house for cremation within the above regulated time limit.
医疗机构对超过规定存放期限的尸体，经医疗机构所在地的公安机关同意后，可以代为移送殡葬馆安置，有关费用由死者家属承担。
For any corpse which is stored beyond the above regulated time limit in the mortuary, the medical institution may transport it to the funeral house for cremation instead with approval of the public security organs in the locality where the medical institution is located; and all the related expenses shall be borne by the family member of the deceased.
患传染病或者对死亡原因有争议的病人尸体，按国家有关规定处理。
The corpse of a patient, who has died of infectious disease or whose death cause is in dispute, shall be disposed of according to relevant stipulations of the State.
第五章法律责任
Chapter V Legal Liability
第四十九条（擅自执业的处罚）
Article 49 (Penalties on Unauthorized Practice)
违反本办法规定，有下列行为之一的，由卫生行政部门责令其停止执业活动，没收非法所得和药品、器械，并可以根据情节轻重处以4000元以上1万元以下的罚款：
If a medical institution violates the present Procedures by doing any one of the following acts, the Public Health Administrative Department shall order the medical institution to suspend its practising activities, confiscate its illegal gains, medicines and apparatus, and may also impose a fine of 4,000 yuan up to no more than 10,000 yuan upon the medical institution according to the seriousness of the wrongdoing:
（一）未取得或者被吊销、注销《医疗机构执业许可证》，从事医疗执业活动；
1. Being engaged in medical practising activities without the "Practice License of Medical Institution", or the license being revoked or canceled;
（二）未经卫生行政部门许可，医疗机构在本机构以外的场所组织医务人员从事医疗执业活动；
2. The medical institution organizing medical persons to carry out medical practising activities at places outside the medical institution without approval of the Public Health Administrative Department;
（三）未经卫生行政部门许可，单位内部医疗机构向社会开放；
3. The internal medical institution of a unit being opened to the public without approval of the Public Health Administrative Department; or
（四）未办理变更登记，医疗机构改变名称、类别、床位、地点。
4. The medical institution changing its name, classification, number of sickbeds and address without going through the alteration registration procedures.
第五十条（逾期不校验的处罚）
Article 50 (Penalties on Not Having the Inspection Within the Time Limit)
医疗机构违反本办法规定，逾期未办理《医疗机构执业许可证》校验手续仍从事医疗执业活动的，由卫生行政部门责令10日内补办校验手续；
If a medical institution violates the provisions of the present Procedures, i.e. remains being engaged in medical practising activities without having the required inspection of the "Practice License of Medical Institution"within the time limit, the Public Health Administrative Department shall order it to make up the inspection within 10 days;
逾期不补办校验手续的，由卫生行政部门予以通报，并由上级主管部门对其主要负责人给予行政处分；拒不校验的，由卫生行政部门吊销其《医疗机构执业许可证》。
if the make-up inspection is still not done after the deadline, the Public Health Administrative Department shall circulate a notice of criticism and give the principal person in charge of the medical institution an administrative disciplinary punishment.
第五十一条（出卖、出借、转让许可证的处罚）
Article 51 (Penalties on Selling, Lending or Transferring Practice License)
医疗机构违反本办法规定，出卖、出借、转让《医疗机构执业许可证》，或者借用、冒用其他医疗机构名义从事医疗执业活动的，由卫生行政部门没收其非法所得，并可处以2000元以上5000元以下的罚款；情节严重的，吊销其《医疗机构执业许可证》。
If a medical institution sell, lend or transfer the "Practice License of Medical Institution", or borrow or fraudulently use the name of other medical institution to carry out medical practising activities in violation of the present Procedures; the Public Health Administrative Department shall confiscate its illegal gains and may impose a fine of 2,000 yuan up to no more than 5,000 yuan upon the medical institution; and may revoke its "Practice License of Medical Institution"in serious case.
第五十二条（超出登记范围的处罚）
Article 52 (Penalties on Acts beyond the Registered Scope)
医疗机构违反本办法规定，有下列行为之一的，由卫生行政部门责令其限期改正，并可处以1000元以上3000元以下的罚款；情节严重的，吊销其《医疗机构执业许可证》：
If a medical institution commits one of the following acts in violation of the present Procedures, the Public Health Administrative Department shall order it to make rectification within the prescribed time limit, and impose a fine of 1,000 yuan up to no more than 3,000 yuan upon it; and may revoke its "Practice License of Medical Institution"in serious case:
（一）未经卫生行政部门批准，改变诊疗科目、服务方式；
1. Changing its medical subjects of diagnosis and treatment or mode of services without approval of the Public Health Administrative Department;
（二）未经市卫生行政部门批准，引进国外医学新技术、新项目；
2. Importing new medical technology or new medical project from abroad without approval of the Municipal Public Health Administrative Department; or
（三）个体诊所、个体护理站聘用在职卫生技术人员或者储备药品。
3. A private clinic or a private nursing station employing in-service public health technical persons or storing up medicines.
第五十三条（使用无卫生技术资格证书人员的处罚）
Article 53 (Penalties on Employing Persons Without the Qualification Certificate of Public Health Technique)
医疗机构违反本办法规定，使用无卫生技术资格证书的人员从事医疗卫生技术工作的，由卫生行政部门责令其限期改正，并可处以3000元以上5000元以下的罚款；情节严重的，吊销其《医疗机构执业许可证》。
If a medical institution employs persons without the qualification certificate of public health technique to carry out the medical and health technique work in violation of the present Procedures, the Public Health Administrative Department shall order it to make rectification within the prescribed time limit, and impose a fine of 3,000 yuan up to no more than 5,000 yuan upon it; and may revoke its "Practice License of Medical Institution"in serious case.
第五十四条（出具虚假证明的处罚）
Article 54 (Penalties on Issuing False Certificates)
医疗机构违反本办法规定，出具虚假疾病诊断书、健康证明书、死亡证明书、出生证明书、死产报告书的，由卫生行政部门予以警告，并可处以500元以下的罚款；
If a medical institution issues a false diagnosis report on disease, health certificate, death certificate, birth certificate or dead-birth report in violation of the present Procedures, the Public Health Administrative Department shall give it a disciplinary warning, and may impose a fine of no more than 500 yuan upon it.
对造成危害后果的，可处以500元以上1000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。
If the case has caused a harmful consequence, a fine of 500 yuan up to no more than 1,000 yuan may be imposed upon it, and simultaneously the direct responsible person shall be given an administrative disciplinary punishment by the unit or by the higher authorities.
第五十五条（处罚程序）
Article 55 (Procedures of Penalties)
卫生行政部门作出行政处罚时，应当出具《行政处罚决定书》。收缴罚没款时，应当出具市财政局统一印制的罚款收据。
When the Public Health Administrative Department gives an administrative disciplinary punishment, it shall issue a Decision on Administrative Disciplinary Punishment. It shall also provide a penalty receipt unifiedly printed by the Municipal Finance Bureau when a fine or the confiscated money is collected.
罚没款收入按规定上缴国库。
All the penalized and confiscated money shall be turned over to the State Treasury according to stipulations.
第五十六条（复议和诉讼）
Article 56 (Reconsideration and Administrative Litigation)
当事人对卫生行政部门的具体行政行为不服的，可以根据《行政复议条例》和《中华人民共和国行政诉讼法》的规定，申请行政复议或者提起行政诉讼。
A party concerned, which (or who) disagrees with the concert administrative acts of the Public Health Administrative Department, may apply for an administrative reconsideration or bring an administrative action according to the Regulations on Administrative Reconsideration"or the "Administrative Litigation Law of the People''s Republic of China.
当事人在法定期限内不申请复议、不提起诉讼，又不履行具体行政行为的，作出具体行政行为的部门可以依照《中华人民共和国行政诉讼法》的规定，申请人民法院强制执行。
In case the party concerned does not apply for a reconsideration or to bring an administrative action within the legal time limit; nor does it fulfill the specific administrative acts; the Public Health Administrative Department that has done the specific administrative acts may apply to the People''s Court for enforcement in accordance with the Administrative Litigation Law of the People''s Republic of China.
第五十七条（妨碍公务的处理）
Article 57 (Penalties on Interference With Public Function)
对拒绝、阻碍卫生执法人员依法执行职务，未使用暴力、威胁方法的，由公安部门按照《中华人民共和国治安管理处罚条例》处理；对构成犯罪的，依法追究其刑事责任。
In case the public health law enforcement persons are refused or hindered from performing in accordance with law their official duties, penalties shall be imposed according to the Regulations of the People''s Republic of China on Public Security Administration and Imposition of Punishment if no violence or duress is used. Those whose act constitutes a crime shall be prosecuted for their criminal liability.
第五十八条（妨碍医疗秩序的处理）
Article 58 (Penalties on Hindrance Against Medical Working Order)
单位或者个人扰乱医疗机构正常秩序的，由公安机关按照《中华人民共和国治安管理处罚条例》进行处罚；情节严重构成犯罪的，由司法机关依法追究其刑事责任。
Any unit or individual, which (or who) has disturbed the normal order of a medical institution, shall be penalized in accordance with the Regulations of the People''s Republic of China on Public Security Administration and Imposition of Punishment. Those whose act is serious enough to constitute a crime shall be prosecuted for their criminal liability by the judicial organs.
第五十九条（对责任者的处理）
Article 59 (Penalties on the Liable Persons)
对违反本办法的医疗机构负责人和直接责任人员，由其上级主管部门给予行政处分；情节严重构成犯罪的，由司法机关依法追究其刑事责任。
The principal person in charge of a medical institution and the directly liable person in violation of the present Procedures shall be given an administrative disciplinary punishment by its higher competent department. If the case is serious enough to constitute a crime, criminal liability shall be investigated by the judicial organs according to law.
第六章附则
Chapter VI Supplementary Provisions
第六十条（执业登记手续的补办）
Article 60 (Retroactive Practice Registration)
本办法施行前已经卫生行政部门批准执业的医疗机构，应当在本办法施行后6个月内，按规定补办执业登记手续，领取《医疗机构执业许可证》。
All the medical institutions, which have been approved by the Public Health Administrative Department to carry out medical practising activities before the implementation of the present Procedures, shall handle a retroactive practising registration within six months after the implementation of the present Procedures according to stipulations, and receive the "Practice License of Medical Institution".
第六十一条（有关用语的含义）
Article 61 (Definition of Related Terms)
本办法下列用语的含义：
Definition of the following terms in the present Procedures:
“医疗执业活动”是指通过各种检查，使用药物、器械及手术等方法，对疾病作出判断和消除疾病、缓解病情、减轻痛苦、改善功能、延长生命、帮助病人恢复健康的活动。
"Medical practising activities"refers to all the activities for diagnosing and curing diseases, mitigating the illness and alleviating patients'' sufferings, improving physical functions, prolonging human life and helping patients recover from their illness by means of different kinds of examination, medicines, medical apparatus application and surgical operation;
“服务方式”是指门诊、急诊、住院、家庭病床、巡诊和其他方式。
"Mode of services"refers to ambulatory treatment, emergency treatment, hospitalization, home sickbeds, mobile medical treatment and other services;
“服务对象”是指医疗机构医疗执业活动指向的人群来源，分社会、内部、境外等。
"Service targets"refers to sources of patients from society, from the unit the medical institution belongs to, or from abroad;
“特殊检查”、“特殊治疗”是指具有下列情形之一的诊断、治疗活动：
"Special examination"and "Special treatment"refer to the diagnosis and treatment activities in any of the following cases;
（一）有一定危险性、可能产生不良后果的检查和治疗；
1. The examination and treatment which have a certain danger and may result in harmful consequences;
（二）由于病人体质特殊或者病情危笃可能对病人产生不良后果和危险的检查和治疗；
2. The examination and treatment which may result in harmful consequences and danger to the patient with special physical constitution or suffering from critical illness; or
（三）临床试验性检查和治疗。
3. Experimental clinical examination and treatment.
“卫生技术人员”是指按照国家有关规定取得卫生技术人员资格或者职称的人员。
"Public health technical persons"refers to those who have obtained the qualification or title of public health technicians according to the relevant State stipulations;
“医疗技术规范”是指卫生部、国家中医药管理局、市卫生行政部门制定的与医疗执业活动有关的技术标准、操作规程等规范性文件。
"Medical technical specification"refers to the standardization documents concerning the technical standards, rules of operation, etc. for medical practising activities; as formulated by the Ministry of Public Health, State Administration of Traditional Chinese Material Medic and the Municipal Public Health Administrative Department.
第六十二条（其他适用）
Article 62 (Other Applications)
向社会开放的部队医疗机构，按照本办法执行。
The present Procedures shall also be applicable to any army medical institution which is opened to the public.
为单位内部职工服务的机关、企业和事业单位门诊部、诊所、卫生所（室）、医务室的设置和执业登记办法，由市卫生行政部门依照本办法另行制定。
The Procedures for the establishment and practice registration of the internal outpatient department, clinic, health station (post) or medical room of a government body, enterprise and institution for the purpose of serving their own employees shall be separately formulated by the Municipal Public Health Administrative Department in accordance with the present Procedures.
第六十三条（应用解释部门）
Article 63 (Organ to Interpret the Application)
本办法的具体应用问题，由市卫生行政部门负责解释。
The Municipal Public Health Administrative Department is responsible for the interpretation of specific problems in application of the present Procedures.
第六十四条（专门规定）
Article 64 (Special Stipulations)
中外合资、中外合作、外资独资医疗机构的设置和管理，按照国家有关规定执行。
The establishment of and administration of medical institutions of Sino-foreign joint ventures, Sino-foreign cooperative ventures, and solely-foreign-owned enterprises shall be conducted in compliance with related State stipulations.
第六十五条（施行和废止）
Article 65 (Implementation and Annulment)
本办法自1997年7月1日起施行。
The present Procedures shall become effective on July 1,1997.
1988年10月29日上海市人民政府颁布的《上海市开业医务人员管理办法》同时废止。
The Procedures of Shanghai Municipality on Administration of Medical Personnel Engaged in Medical Practising Activities promulgated on October 29, 1988 by the Shanghai Municipal People''s Government shall be annulled at the same time.
