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ID:44355667
大小:71.55 KB
页数:14页
时间:2019-10-21
《境内第一类医疗器械注册审批操作规范(试行)》由会员上传分享,免费在线阅读,更多相关内容在工程资料-天天文库。
1、境内第一类医疗器械注册审批操作规范(试行)SpecificationsfortheexaminationandapprovaloftheregistrationandapprovalofmedicaldevicesintheterritoryofChina(forTrialImplementation)Registrationofdomesticmedicaldevicesinthefirstplace(reregistration)ismadeupofacceptanceandadministrativeexaminationandapprova1.Thetotal
2、timelimitforexaminationandapprovalshallbewithin30workingdaysfromthedateofissueoftheacceptancenotice・I.acceptanceMainlytothefirstclassofMedicalDevicesRegistration(reregistration)applicationmaterialsintheformofexamination,toensurethattheapplicationmaterialscompleteandnormative,andtothepub
3、licnoticeofadmissibility・Wheremedicaldevicemanufacturersapplyforregistrationofdomesticmedicaldevicesofthefirstcategory(reregistration),theyshallsubmitthematerialsforregistrationapplicationtothelocal,districtandcity(food)drugsupervisionandadministrationdepartments.(1)acceptancerequiremen
4、ts1.applicationformforregistrationofmedicaldeviceswithintheterritoryAnapplicationformforregistrationofmedicaldeviceswithintheterritoryofthepeople'sRepublicofChinashallbesignedbythelegalrepresentativeandstampedwiththeofficialseal,andtheitemstobefilledinshallbecompleteandaccurate,andtheco
5、ntentsshallbeinaccordancewiththefollowingrequirements:(1)''manufacturingenterprisename,zand''registeredaddress7'arethesameas''industrialandcommercialbusinesslicense";(2)"productname","specificationmodel"andthesubmittedproductstandards,inspectionreportsandotherapplicationmaterialsusedint
6、hename,specifications,modelsconsistent.2.medicaldevicemanufacturingenterprisequalificationcertificateThequalificationcertificateincludesphotocopiesoftheregistrationformforthemanufacturingenterprisesofthefirsttypemedicalinstrumentsandcopiesofthebusinesslicense・(1)theproductsthatapplyforr
7、egistration(reregistration)shallbewithinthescopeofproductionapprovedintheregistrationfonnofthefirstclassmedicaldevicemanufacturer;(2)thebusinesslicenseisvalidwithintheperiodofvalidity・3.applicableproductstandardsandinstructionsTheproductstandardssubmittedbytheenterprisemaybenat
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