Regulation on the Administration of Medical Institutions

第四条 国家扶持医疗机构的发展，鼓励多种形式兴办医疗机构。

Article 5 The health administrative department of the State Council shall be responsible for the ... May31,2010 --------------------- Monday >>>Welcomevisitor,you'renotloggedin. Login   SubscribeNow! Home UserManagement AboutUs Chinese  lawinfochina.com >Laws&Regulations>Text   Bookmark   Download   Print Search:  "Fabao"Window FontSize:   RegulationontheAdministrationofMedicalInstitutions [Revised] 医疗机构管理条例 [已被修订] 【法宝引证码】 Issuingauthority： StateCouncil DocumentNumber： OrderNo.149oftheStateCouncil Dateissued： 02-26-1994 Effectivedate: 09-01-1994 LevelofAuthority: AdministrativeRegulations AreaofLaw:HealthandSanitation Revisedby：DecisionoftheStateCouncilonAmendingCertainAdministrativeRegulations(2016) (Issuedon02-06-2016Effectiveon02-06-2016) PkulawComments：DecisionoftheStateCouncilonaGroupofAdministrativeApprovalItemsCancelledorAdjustedandOtherMatters (Issuedon10-23-2014Effectiveon10-23-2014);DecisionoftheStateCouncilonMattersconcerning50AdministrativeApprovalItemstoBeCancelledandDelegatedtoLowerLevels (Issuedon07-13-2013Effectiveon07-13-2013);DecisionoftheStateCouncilontheCancellationandAdjustmentoftheThirdBatchofAdministrativeApprovalItems (Issuedon05-19-2004Effectiveon05-19-2004)       　 OrderoftheStateCouncilofthePeople'sRepublicofChina(No.149)TheRegulationontheAdministrationofMedicalInstitutions,asherebyissued,shallcomeintoforceonSeptember1,1994.Premier:LiPengFebruary26,1994RegulationontheAdministrationofMedicalInstitutions 中华人民共和国国务院令（第１４９号）现发布《医疗机构管理条例》，自１９９４年９月１日起施行。

总理　李鹏一九九四年二月二十六日医疗机构管理条例 ChapterIGeneralProvisions 第一章　总则 Article1ThisRegulationisdevelopedforpurposesofstrengtheningtheadministrationofmedicalinstitutions,promotingthedevelopmentofthemedicalandhealthcause,andprotectingthehealthofcitizens. 　　第一条　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。

Article2ThisRegulationshallapplytohospitals,healthcenters,nursinghomes,out-patientdepartments,clinics,healthclinics(stations),firstaidstationsandothermedicalinstitutionsengaginginthediagnosisandtreatmentofdiseases. 　　第二条　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。

Article3Medicalinstitutionsaimatretrievingthedyingorrescuingthewounded,preventingandcuringdisease,andservingforthehealthofcitizens. 　　第三条　医疗机构以救死扶伤，防病治病，为公民的健康服务为宗旨。

Article4Thestateshallsupportthedevelopmentofmedicalinstitutionsandencouragetheestablishmentofmedicalinstitutionsinvariousforms. 　　第四条　国家扶持医疗机构的发展，鼓励多种形式兴办医疗机构。

Article5ThehealthadministrativedepartmentoftheStateCouncilshallberesponsibleforthesupervisionandadministrationofthemedicalinstitutionsacrossthecountry.Thehealthadministrativedepartmentsofthelocalpeople'sgovernmentsatorabovethecountylevelshallberesponsibleforthesupervisionandadministrationofthemedicalinstitutionswithintheirrespectiveadministrativeregions.ThecompetenthealthdepartmentoftheChinesePeople'sLiberationArmyshall,underthisRegulationandtherelevantprovisionsofthestate,implementsupervisionandadministrationofthemedicalinstitutionsoftheArmy. 　　第五条　国务院卫生行政部门负责全国医疗机构的监督管理工作。

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。

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。

ChapterIIApprovalforPlanningLayoutandFormation 第二章　规划布局和设置审批 Article6Thehealthadministrativedepartmentsofthelocalpeople'sgovernmentsatorabovethecountylevelshall,accordingtothepopulation,medicalresources,medicalneedsandthedistributionoftheexistingmedicalinstitutionsintheirrespectiveadministrativeregions,developplansfortheformationofmedicalinstitutionswithintheirrespectiveadministrativeregions.Organs,enterprisesandpublicinstitutionsmay,accordingtotheneeds,formmedicalinstitutionsandincorporatethemintotheplansfortheformationoflocalmedicalinstitutions. 　　第六条　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。

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。

Article7Thelocalpeople'sgovernmentsatorabovethecountylevelshallincorporatetheplansfortheformationofmedicalinstitutionsintothelocalregionalhealthdevelopmentplansandoverallplansforurbanandruralconstructionanddevelopment. 　　第七条　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。

Article8Theformationofmedicalinstitutionsshallcomplywiththeplansfortheformationofmedicalinstitutionsandthebasicstandardsformedicalinstitutions.ThebasicstandardsformedicalinstitutionsshallbedevelopedbythehealthadministrativedepartmentoftheStateCouncil. 　　第八条　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。

医疗机构基本标准由国务院卫生行政部门制定。

Article9Toformamedicalinstitution,anentityorindividualshallbesubjecttotheexaminationandapprovalofthehealthadministrativedepartmentofthelocalpeople'sgovernmentatorabovethecountylevelandobtainthewrittenapprovalfortheformationofmedicalinstitutions,beforeundergoingotherformalitieswithrelevantdepartments. 　　第九条　单位或者个人设置医疗机构，必须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，方可向有关部门办理其他手续。

Article10Toapplyforformingamedicalinstitution,anapplicantshallsubmitthefollowingdocuments: 　　第十条　申请设置医疗机构，应当提交下列文件： (1)awrittenapplicationfortheformation; （一）设置申请书； (2)afeasibilitystudyreportfortheformation;and （二）设置可行性研究报告； (3)asiteselectionreportandthedrawingsofarchitecturaldesign. （三）选址报告和建筑设计平面图。

Article11Toformamedicalinstitution,anentityorindividualshallfileanapplicationforformationunderthefollowingprovisions: 　　第十一条　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： (1)Foramedicalinstitutionthathasnosickbedsorhaslessthan100sickbeds,anapplicationshallbefiledwiththehealthadministrativedepartmentofthepeople'sgovernmentofthecountywhereitislocated. （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； (2)Foramedicalinstitutionorspecializedhospitalthathasmorethan100sickbeds,anapplicationshallbefiledundertheprovisionsofthehealthadministrativedepartmentofthepeople'sgovernmentattheprovinciallevel. （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。

Article12Thehealthadministrativedepartmentofthelocalpeople'sgovernmentatorabovethecountylevelshall,within30daysofthedateofacceptinganapplicationforformation,issueawrittenreplyofapprovalordisapproval;andissueawrittenapprovalfortheformationofaninstitution,whereapprovalisgranted. 　　第十二条　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。

Article13TheformationofmedicalinstitutionsundertheunifiedplanofthestateshallbedecidedbythehealthadministrativedepartmentoftheStateCouncil. 　　第十三条　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。

Article14Organs,enterprisesandpublicinstitutionsthatformout-patientdepartments,clinicsandhealthclinics(stations)servingtheiremployeesaccordingtothebasicstandardsofthestateformedicalinstitutionsshallsubmittherelevantmaterialstothehealthadministrativedepartmentsofthepeople'sgovernmentsofthecountywheretheyarelocatedforrecordation. 　　第十四条　机关、企业和事业单位按照国家医疗机构基本标准设置为内部职工服务的门诊部、诊所、卫生所（室），报所在地的县级人民政府卫生行政部门备案。

ChapterIIIRegistration 第三章　登记 Article15AmedicalinstitutionprovidingrelevantservicesshallconductregistrationandobtainthePracticingLicenseforaMedicalInstitution. 　　第十五条　医疗机构执业，必须进行登记，领取《医疗机构执业许可证》。

Article16Toapplyforpracticingregistration,amedicalinstitutionshallmeetthefollowingconditions: 　　第十六条　申请医疗机构执业登记，应当具备下列条件： (1)Ithasawrittenapprovalfortheformationofamedicalinstitution. （一）有设置医疗机构批准书； (2)Itcomplieswiththebasicstandardsformedicalinstitutions. （二）符合医疗机构的基本标准； (3)Ithasanappropriatename,organizinginstitutionandplace. （三）有适合的名称、组织机构和场所； (4)Ithasfunds,facilities,equipmentandprofessionalhealthtechnicalpersonnelthatarecompatiblewiththebusinesscarriedout. （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； (5)Ithascorrespondingrulesandregulations. （五）有相应的规章制度； (6)Itisabletoindependentlyassumecivilresponsibilities. （六）能够独立承担民事责任。

Article17Thepracticingregistrationofmedicalinstitutionsshallbehandledbythehealthadministrativedepartmentsofthepeople'sgovernmentsapprovingtheirformation.ThepracticingregistrationofmedicalinstitutionsformedundertheprovisionsofArticle13ofthisRegulationshallbehandledbythehealthadministrativedepartmentsofthepeople'sgovernmentsoftheprovinces,autonomousregionsandmunicipalitiesdirectlyundertheCentralGovernmentwheretheyarelocated.Thepracticingregistrationoftheout-patientdepartments,clinicsandhealthclinics(stations)formedbyorgans,enterprisesandpublicinstitutionsforservingtheiremployeesshallbehandledbythehealthadministrativedepartmentsofthepeople'sgovernmentsofthecountywheretheyarelocated. 　　第十七条　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。

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。

机关、企业和事业单位设置的为内部职工服务的门诊部、诊所、卫生所（室）的执业登记，由所在地的县级人民政府卫生行政部门办理。

Article18Themainitemsofthepracticingregistrationofamedicalinstitutioninclude:．．．．．． 　　第十八条　医疗机构执业登记的主要事项：．．．．．． Dearvisitor,youareattemptingtoviewasubscription-basedsectionoflawinfochina.com.Ifyouarealreadyasubscriber,pleaselogintoenjoyaccesstoourdatabases.Ifyouarenotasubscriber,pleasesubscribe.Shouldyouhaveanyquestions,pleasecontactusat:+86(10)8268-9699or+86(10)8266-8266(ext.153)Mobile:+86133-1157-0713Fax:+86(10)[email protected] 您好：您现在要进入的是北大法律英文网会员专区，如您是我们英文用户可直接登录，进入会员专区查询您所需要的信息；如您还不是我们的英文用户，请注册并交纳相应费用成为我们的英文会员。

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