中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第1頁

LicenseRequirement中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第2頁3

01Department

中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第3頁4

LicenseRequirementCompanyNamePre-approval（企業(yè)名稱預核準）ApprovalbyCOC（商務(wù)主管部門批復）MedicalEquipmentBusiness

License（醫(yī)療器械經(jīng)營許可證）BusinessLicense(營業(yè)執(zhí)照)Corporateseal（公章）TaxRegistrationCertificat（稅務(wù)登記證）

EnterpriseCodeCertificate(組織機構(gòu)代碼證)

FinanceRegistrationCertificate（財政登記證）

StatisticsRegistrationCertificate(統(tǒng)計登記證)中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第4頁

STEP1

EnterpriseNamePre-approval（企業(yè)名稱預核準）TimeScale：3~5

workingdays

Department

RequireddocumentsAdministrationforIndustryandCommerce（工商行政管理局）ApplicationforPre-approvalofEnterpriseNamesignedbyallinvestors投資人簽署《企業(yè)名稱預先核準申請書》LetterAuthorizationsignedbyallinvestorsandIDcardcopyoftheMandatary(全體投資人簽署授權(quán)委托書以及代理人身份證復印件)中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第5頁

STEP2

ApprovalofCOC（商務(wù)主管部門批復）TimeScale：15-20workingdays

Department

RequireddocumentsCommissionofCommerce（商務(wù)委員會）AdministrativeLicenseApplication

行政許可事項申請書FeasibilityStudyReport可行性研究匯報LetterofAuthorizationforReceivingLegalDocuments法律文件送達授權(quán)委托書NotificationofPre-approvalofEnterpriseName企業(yè)名稱預先核準通知書Listofthelegalrepresentativeorboardofdirectors外資企業(yè)法定代表人（或董事會人選）名單

LetterofAuthorizationandtheCopyofIDCardofmandatary授權(quán)委托書及受托人身份證復印件ArticlesofAssociation,IdentitycertificatesofforeigninvestorsorlegalqualificationcertificateofthecorporationandCertificateofCreditStatus外資企業(yè)章程，經(jīng)公證和依法認證境外投資者身份證實文件或注冊登記證實及資信證實文件ApprovalbyDevelopmentandReformCommission發(fā)展改革部門做出項目核準批復中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第6頁STEP3

Medicalequipmentbusiness

License

（醫(yī)療器械經(jīng)營許可證）TimeScale:

About30workingdaysDepartment

RequireddocumentsApplicationforMedicalequipmentbusiness

License醫(yī)療器械經(jīng)營許可證申請表CertificateforPre-approvalRegistrationofEnterpriseName企業(yè)名稱預先核準通知書OrganizationandFunction組織機構(gòu)與職能FiledirectoryofProductqualitymanagementregulation產(chǎn)品質(zhì)量管理制度文件目錄LetterAuthorizationsignedbyEnterprise企業(yè)簽署授權(quán)委托書StatementofGuaranteeontheAuthenticityoftheInformationSubmitted材料真實性確保申明IDcard,DiplomaorProfessionaltitlecertificateofqualitymanagers(Originalandcopy)andtheirresume質(zhì)量管理人員身份證、學歷或者職稱證實原件和復印件及個人簡歷Registeredaddressandthelocationmapandplans(specifyarea)ofwarehouseandthecopyofRealestateownershipcertificationorotherCertificateofrightstousetheRealestate注冊地址（企業(yè)注冊經(jīng)營地址）和倉庫地址地理位置圖與平面圖（注明面積）以及房屋產(chǎn)權(quán)和使用權(quán)證實復印件

Food

andDrugAdministration（食品藥品監(jiān)督管理局）

中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第7頁STEP4

BusinessLicense（營業(yè)執(zhí)照）TimeScale:10-15workingdays

DepartmentPrecondition

RequiredDocuments

ApplicationforForeign-investedEnterpriseEstablishmentRegistrationsignedbyLegalrepresentative法定代表人簽署《外商投資企業(yè)設(shè)置登記申請書》ArticlesofAssociationsignedbyallshareholders全體股東簽署企業(yè)章程Certificationforthelegalpersonqualificationofshareholderorthecopyidentificationofnaturalperson股東主體資格證實或者自然人身份證件復印件certificateofapprovalofCOC(duplicate1)商務(wù)部門出具《外商投資企業(yè)同意證書》副本1CertificateforPre-approvalRegistrationofEnterpriseName

企業(yè)名稱預先核準通知書LetterAuthorizationsignedbyallshareholders全體股東簽署授權(quán)委托書RegistryformofEnterpriseContacts企業(yè)聯(lián)絡(luò)人記錄表Domicilecertificate(ThecopyofRealestateownershipcertificationsignedbypropertyowner)住所使用證實（產(chǎn)權(quán)人簽字蓋章房產(chǎn)證復印件）MedicalequipmentbusinessLicense醫(yī)療器械經(jīng)營企業(yè)許可證LetterofAuthorizationforReceivingLegalDocuments《法律文書送達授權(quán)委托書》Administration

IndustryandCommerce工商行政管理局Pre-approvalRegistrationofEnterpriseName企業(yè)名稱預核準MedicalequipmentbusinessLicense醫(yī)療器械經(jīng)營企業(yè)許可證中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第8頁STEP5

Corporateseal（公章）TimeScale:7

workingdayCompany

RequireddocumentsAuthorizedSealscompany（制訂刻章企業(yè)）Businesslicense企業(yè)營業(yè)執(zhí)照副本原件、復印件IdentificationoftheLegalRepresentative企業(yè)法定代表人身份證實

LetterAuthorizationsignedbythelegalRepresentative法人授權(quán)委托書OriginalandcopyoftheeffectiveIdentityCertificateofthemandatary經(jīng)辦人有效身份證實原件及復印件中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第9頁STEP

6

TaxRegistrationCertificate

（稅務(wù)登記證）TimeScale:1workingdayDepartment

RequireddocumentsStatetaxbureau國稅局Localtaxbureau地稅局

Taxregistrationform（Entitiestaxpayer）稅務(wù)記錄表（單位納稅人）businesslicense(Originalandcopy)工商營業(yè)執(zhí)照或其它核準執(zhí)業(yè)證件原件及復印件ArticlesofAssociation(Originalandcopy)企業(yè)章程原件及復印件DuplicateofEnterpriseCodeCertificate(Originalandcopy)組織機構(gòu)統(tǒng)一代碼證書副本原件及復印件IDCard、passportorotheridentificationsoflegalrepresentatives（法定代表人居民身份證、護照或其它證實身份正當證件原件及復印件）ApprovalofCOC（Originalandcopy）商務(wù)部門批復設(shè)置證書原件及復印件TheCertificationofRegisteredaddress,managementaddressandtheaddressofproduction注冊地址及生產(chǎn)、經(jīng)營地證實中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第10頁STEP7

EnterpriseCodeCertificateTimeScale:1workingdayDepartment

RequireddocumentsBureauofQualityandTechnicalSupervision質(zhì)量技術(shù)監(jiān)督局

SealedApplicationforEnterpriseCodeCertificate加蓋有單位公章《中華人民共和國組織機構(gòu)代碼申請表》

businesslicense(Originalandcopy)營業(yè)執(zhí)照副本及其復印件Identificationsoflegalrepresentatives(Originalandcopy)法定代表人身份證件及其復印件IDcardofmandatary(Originalandcopy)經(jīng)辦人身份證原件及其復印件Corporateseal企業(yè)公章Theapprovalofthenationalorganizationcode全國組織機構(gòu)代碼賦碼通知單（新申請設(shè)置外資企業(yè)法人，須持商務(wù)局同意文件，工商行政管理部門名稱預先核準通知書及復印件，經(jīng)辦人身份證及復印件到組織機構(gòu)代碼管理中心服務(wù)大廳申辦預賦碼登記，取得全國組織機構(gòu)代碼賦碼通知單）中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第11頁STEP8FinanceRegistrationCertificate（財政登記證）Department

RequireddocumentsBureau

of

Finance

財政局ApprovalcertificateofEstablishmentofenterprise(Originalandcopy)企業(yè)設(shè)置同意證書(原件及復印件)BusinessLicense;TaxRegistrationCertificate;EnterpriseCodeCertificate工商營業(yè)執(zhí)照、國稅、地稅稅務(wù)登記證、組織機構(gòu)代碼證FinancialregistrationcardofForeign-fundedenterprise《外商投資企業(yè)財政登記卡》Contractandarticlesofassociationoftheforeign-fundedenterprise外商投資企業(yè)協(xié)議、章程及董事會組成批復AccountOpeningLicense;ForeignexchangeregistrationcertificateorSignaturecard銀行開戶許可證、外匯登記證或預留印鑒卡TimeScale:7workingday中英文對照醫(yī)療器械經(jīng)營企業(yè)設(shè)立流程第12頁STEP9

StatisticsRegistrationCertificate(統(tǒng)計登記證）TimeScale:7

workingdayDepartment

RequireddocumentsBureauofStatistic統(tǒng)計局BusinessLicense企業(yè)營業(yè)執(zhí)照或副本原件或加蓋公章復印件EnterpriseCodeCertificate組織機構(gòu)代碼證（副本原件或加蓋公章復印件）Corporateseal單位公章Fundamentalinform