2015年醫(yī)療器械臨床評價技術(shù)指導(dǎo)原則(英文版)_第1頁
已閱讀1頁，還剩24頁未讀， 繼續(xù)免費閱讀

下載本文檔

版權(quán)說明：本文檔由用戶提供并上傳，收益歸屬內(nèi)容提供方，若內(nèi)容存在侵權(quán)，請進行舉報或認領(lǐng)

文檔簡介

1、—1—AnnexTechnicalGuidelinesfClinicalAppraisalofMedicalDevicesⅠDraftingobjectiveClinicalappraisalofmedicaldevicesistheprocessimplementedbyregistrationapplicanttoidentifywhethertheproductfulfillsusagerequirementsapplicatio

2、nscopeaccdingtoinfmationconcerningclinicaldocumentsclinicalexperiencesdataclinicaltrialssoon.Thisguidelinesisintendedtoprovidetechnicalguidefregistrationapplicanttocarryoutclinicalappraisalaswellasfthefooddrugadministrat

3、ionauthitiestoreviewclinicalappraisaldocuments.ⅡLawsregulationsbasis(Ⅰ)“Medicaldevicesmanagementregulations”No.650decreeofthestatecouncil(Ⅱ)“Medicaldevicesregistrationmanagementspecifications”No.4decreeofthestatecouncil(

4、Ⅲ)Relevantspecificationsfclinicaltrialqualitymanagementofmedicaldevices.ⅢApplicationscopeThisguidelinesisapplicabletoclinicalappraisalofclassⅡclassⅢmedicaldeviceswhentheyareappliedfregistration.Itisnotapplicabletoclinica

5、lappraisalofinvitrodiagnostic(IVD)reagentsadministratedasmedicaldevices.Ifthereisclinicalappraisaltechnicalguidelinesfspecificproductthecrespondingclinicalappraisalshouldfollowrelevantrequirementsofit.ⅣBasicprincipleClin

6、icalappraisalshouldbecomprehensiveaswellasobjectivecrespondingdatashouldbecollectedbyvariousmeanssuchasclinicaltrials—3—includedinthe“catalogue“whichhavealreadyacquireddomesticregistrationpermission.Comparisonexplanation

7、shouldinclude“Comparisonfmfdeclaredproductthemedicaldevicesinthe“catalogue“whichhasalreadyacquireddomesticregistrationpermission“(refertoannex1)crespondingsupptivedocuments.Theabovementionedsubmitteddocumentsshouldprovet

8、heequivalencebetweendeclaredproducttheproductlistedinthe“catalogue“.Ifequivalencebetweendeclaredproducttheproductlistedinthe“catalogue“cannotbeprovedcrespondingjobsshouldbecarriedoutaccdingtootherrequirementsinthisguidel

9、ines.Ⅵ.Requirementsfanalysisappraisalwithdatafromclinicaltrialclinicaluseofthesamevarietymedicaldevices.(Ⅰ)Thesamevarietymedicaldevices1DefinitionofthesamevarietymedicaldevicesThesamevarietymedicaldevicesarethedomesticre

10、gisteredproductswhichareidenticaltothedeclaredproductintheaspectsofbasicprinciplestructurecompositionmanufacturingmaterial(itrefertothemanufacturingmaterialincontactwithhumanbodyfactiveproducts)manufacturingtechnologyper

11、fmancerequirementssafetyappraisalimplementednationalprofessionalstardsintendedapplicationsoon.Ifthedifferencebetweendeclaredproductthesamevarietymedicaldeviceshasnoadverseinfluenceonproductsafetyeffectivenesstheycanbejud

12、gedasbasicequivalent.2.JudgmentofthesamevarietymedicaldevicesWhenanalysisappraisalisimplementedwithdatafromclinicaltrialclinicaluseofthesamevarietymedicaldevicestoprovethesafetyeffectivenessofmedicaldevicesregistrationap

溫馨提示

  • 1. 本站所有資源如無特殊說明，都需要本地電腦安裝OFFICE2007和PDF閱讀器。圖紙軟件為CAD,CAXA,PROE,UG,SolidWorks等.壓縮文件請下載最新的WinRAR軟件解壓。
  • 2. 本站的文檔不包含任何第三方提供的附件圖紙等，如果需要附件，請聯(lián)系上傳者。文件的所有權(quán)益歸上傳用戶所有。
  • 3. 本站RAR壓縮包中若帶圖紙，網(wǎng)頁內(nèi)容里面會有圖紙預(yù)覽，若沒有圖紙預(yù)覽就沒有圖紙。
  • 4. 未經(jīng)權(quán)益所有人同意不得將文件中的內(nèi)容挪作商業(yè)或盈利用途。
  • 5. 眾賞文庫僅提供信息存儲空間，僅對用戶上傳內(nèi)容的表現(xiàn)方式做保護處理，對用戶上傳分享的文檔內(nèi)容本身不做任何修改或編輯，并不能對任何下載內(nèi)容負責(zé)。
  • 6. 下載文件中如有侵權(quán)或不適當內(nèi)容，請與我們聯(lián)系，我們立即糾正。
  • 7. 本站不保證下載資源的準確性、安全性和完整性, 同時也不承擔(dān)用戶因使用這些下載資源對自己和他人造成任何形式的傷害或損失。

評論

0/150

提交評論