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(1). Procedures of Shanghai Municipality on Administration Over Medical Institutions

上海市医疗机构管理办法

(2). (Promulgated by Decree No. 39 of the Shanghai Municipal People’’s Government on March 2, 1997)

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

(3). 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.

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。

(4). 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.

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。

(5). 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.

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。

(6). 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.

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。

(7). 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.

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。

(8). Every public health administrative department shall nominate medical practice supervisors who shall undertake the supervisory and administrative work of medical practice of medical institutions.

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。

(9). 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.

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。

(10). Article 5 (Professional Aim and Legal Protection)

第五条(职业宗旨和法律保护)

(11). 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.

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。

(12). Medical institutions established according to law and legal medical practising activities are all protected by law.

依法设置医疗机构和从事医疗执业活动，受法律保护。

(13). The practice license system is adopted in Shanghai for medical institutions.

本市对医疗机构实行执业许可证制度。

(14). Any unit or individual person shall not be engaged in medical practising activities without getting a practice license.

未经许可，任何单位和个人不得从事医疗执业活动。

(15). Article 7 (The Appraisal and Examination System for Medical Institutions)

第七条(医疗机构评审制度)

(16). 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.

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。

(17). The result of the appraisal shall be one of the important criteria for examining the "Practice License of Medical Institution".

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。

(18). The appraisal and examination work of medical institutions shall be conducted according to the "Appraisal and Examination Rules for Medical Institutions".

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。

(19). 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,

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，

(20). work out the Municipal Program for the Establishment of Medical Institutions which shall, after being comprehensively balanced by the Municipal Program Administrative Department,

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，

(21). be submitted to Municipal People’’s Government for approval, and then be incorporated into the Municipal Public Health Development Program and the Overall Urban Development Program.

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。

(22). District or County Public Health Adm. 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 People’’s Government for approval

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

(23). 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.

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。

(24). The application for the establishment of a medical institution shall meet the following requirements:

申请设置医疗机构，应当具备下列条件:

(25). 1. In conformity to the Municipal Program of the Establishment of Medical Institutions;

(一)符合本市医疗机构设置规划;

(26). 2. In conformity to the Basic Standards for Medical Institutions stipulated by the State;

(二)符合国家规定的医疗机构基本标准;

(27). 3. With a suitable premise for establishing the medical institution; and

(三)有合适的场所;

(28). 4. With necessary fund.

(四)有必要的资金。

(29). Article 11 (Requirements for the Establishment of a Private Clinic or a Private Nursing Station)

第十一条(个体诊所、个体护理站的设置条件)

(30). 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:

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:

(31). 1. With permanent residential registration in Shanghai;

(一)具有本市常住户口;

(32). 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

(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;

(33). 3. Non-in-service employee(s).

(三)非在职人员。

(34). Any organization, which is unable to bear civil liability independently, can not apply for the establishment of a medical institution.

不能独立承担民事责任的组织，不得申请设置医疗机构。

(35). No person in any one of the following cases is permitted to 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:

(36). 1. The person who is incapable of, or with restricted capacity of, doing a civil act;

(一)无民事行为能力或者限制民事行为能力的人员;

(37). 2. The person who is serving a sentence liability or receiving reeducation through labour;

(二)正在服刑或者劳动教养的人员;

(38). 4. The person who bears direct liability for a medical accident of Class II or above, which has not yet been five years;

(四)发生二级以上医疗事故未满 5 年的直接责任人员;

(39). 5. The medical person whose certificate of practice is revoked;

(五)被吊销执业证书的医务人员;

(40). 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;

(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;

(41). 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;

(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;

(42). 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.

(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。

(43). Article 13 (Application Documents to Be Submitted)

第十三条(申请材料的提交)

(44). 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:

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:

(45). 1. An application for establishment;

(一)设置申请书;

(46). 2. Site selection report and the drawings of architectural design;

(二)选址报告和建筑设计平面图;

(47). 3. The feasibility study report;

(三)可行性研究报告;

(48). 4. The certificate of credit standing and respectability of the establishment applicant; and

(四)设置申请人的资信证明;

(49). 5. The certificate of the basic condition of the establishment applicant.

(五)设置申请人的基本情况证明。....(please sign in for more)

(50). Article 14 (Application Documents to Be Submitted for the Establishment of A Private Clinic or A Private Nursing Station)

第十四条(申请设置个体诊所、个体护理站应当提交的材料)....(please sign in for more)

(51). The following documents shall be submitted on application 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:....(please sign in for more)

(52). 2. The certificate of house property right or the certificate of house use rights; and

(二)房屋产权证明或者使用权证明;....(please sign in for more)

(53). 3. All of the related certificates which fully prove that the establishment applicant meets the requirements stipulated in Article 10 of the present Procedures.

(三)设置申请人具备本办法第十条规定条件的相关证明。....(please sign in for more)

(54). 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.

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。....(please sign in for more)

(55). 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:

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:....(please sign in for more)

(56). 1. Grade-III hospital, Grade-II hospital and convalescence hospital;

(一)三级医院、二级医院、康复医院;....(please sign in for more)

(57). 2. Sanatorium, women and children care center (station)and disease prevention and cure center (station);

(二)疗养院、妇幼保健院(所)、疾病防治院(所);....(please sign in for more)

(58). 3. Medical first-aid center (station);

(三)医疗急救中心(站);....(please sign in for more)

(59). 5. Other medical institutions stipulated by the Municipal Public Health Administrative Department.

(五)市卫生行政部门规定的其他医疗机构。....(please sign in for more)

(60). 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:

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:....(please sign in for more)

(61). (4)Nursing center (station); and

(四)护理院(站);....(please sign in for more)

(62). (5)Health center (station, post)and health-care station.

(五)卫生所(站、室)、保健所。....(please sign in for more)

(63). Article 17 (Principle and Procedure for Examining and Approving the Establishment)

第十七条(设置审批原则和审批程序)....(please sign in for more)

(64). 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。....(please sign in for more)

(65). 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.

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。....(please sign in for more)

(66). Before examining and issuing the Approval Certificate for the Establishment of Medical Institution, the District or County Public Health Administrative Department

区、县卫生行政部门在核发《设置医疗机构批准书》之前....(please sign in for more)

(67). shall inform the applicant of going through the formalities for the Name Ratification of the medical institution with the Municipal Public Health Administrative Department;

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，....(please sign in for more)

(68). and the Municipal Public Health Administrative Department shall reply in writing within 10 days after receiving the written application for the Name Ratification.

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。....(please sign in for more)

(69). During the Name Ratification period, the procedure of examination and approval of the establishment shall be suspended.

核准名称期间，设置审批程序中止。....(please sign in for more)

(70). 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.

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。....(please sign in for more)

(71). Article 18 (The Validity Period of the Approval Certificate)

第十八条(批准书有效期)....(please sign in for more)

(72). 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:

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:....(please sign in for more)

(73). 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;

(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;....(please sign in for more)

(74). 2. One year for out  patient department, medical first-aid station and nursing center; and

(二)门诊部、医疗急救站、护理院为1年;....(please sign in for more)

(75). 3. Six months for clinic, nursing station, health center (station, post), and health-care station.

(三)诊所、护理站、卫生所(站、室)、保健所为 6 个月。....(please sign in for more)

(76). Article 19 (Procedure for Examining and Approving the Alteration, Re-establishment, and for Examining and Approving the Establishment of Branches)

第十九条(变更、重新设置审批和分支机构的审批)....(please sign in for more)

(77). 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，其经核准的名称、诊疗科目发生变更的，应当申请办理变更审批手续。....(please sign in for more)

(78). 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 reapply for the establishment examination and approval.

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。....(please sign in for more)

(79). 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.

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;....(please sign in for more)

(80). 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.

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。....(please sign in for more)

(81). 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.

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;....(please sign in for more)

(82). 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.

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。....(please sign in for more)

(83). Article 21 (Process of Application for the Registration)

第二十一条(申请登记手续)....(please sign in for more)

(84). 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".

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》。....(please sign in for more)

(85). Article 22 (Requirements for the Registration Application)A medical institution shall meet the following requirements on application for the practice registration:

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:....(please sign in for more)

(86). 1. With the "Approval Certificate for the Establishment of Medical Institution";

(一)有《设置医疗机构批准书》;....(please sign in for more)

(87). 3. With an organizational structure conforming to the related stipulations;

(三)有符合规定的组织机构;....(please sign in for more)

(88). 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;

(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;....(please sign in for more)

(89). 5. With relevant rules and regulations; and

(五)有相应的规章制度;....(please sign in for more)

(90). 6. Capable of undertaking civil liability independently.

(六)能够独立承担民事责任。....(please sign in for more)

(91). Article 23 (Materials to be Submitted with the Application for Registration)

第二十三条(申请登记应当提交的材料)....(please sign in for more)

(92). A medical institution shall submit the following materials on application for the practice registration:

医疗机构申请办理执业登记手续，应当提交下列材料:....(please sign in for more)

(93). 1. "The Practice Registration Application for the Medical Institution";

(一)《医疗机构申请执业登记注册书》;....(please sign in for more)

(94). 2. "The Approval Certificate for the Establishment of Medical Institution";

(二)《设置医疗机构批准书》;....(please sign in for more)

(95). 3. The certificate of house property right or the certificate of house use right;

(三)房屋产权证明或者使用证明;....(please sign in for more)

(96). 4. The fund verification certificate;

(四)验资证明;....(please sign in for more)

(97). 5. The drawing of the architectural design of the medical institution;

(五)医疗机构建筑设计平面图;....(please sign in for more)

(98). 6. The rules and regulations of the medical institution; and

(六)医疗机构规章制度;....(please sign in for more)

(99). 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.

(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。....(please sign in for more)

(100). 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.

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;....(please sign in for more)