(英文版)医疗器械临床试验质量管理规范.pdf
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1、FG-20160601025Good Clinical Practice for MedicalGood Clinical Practice for MedicalDevicesDevices(No.25 Order of CFDA and NHFPC)(No.25 Order of CFDA and NHFPC)Order of China Food and Drug Administration and National HealthOrder of China Food and Drug Administration and National Healthand Family Plann
2、ing Commission of Chinaand Family Planning Commission of ChinaNo.25Adopted at the meeting of CFDA and NHFPC,this practice is herebypromulgated,and shall take effect as of June 1,2016.DirectorBi JingquanDirector Li BinMarch 1,2016专业医疗器械咨询维康嘉业网址:www.vicon- 邮箱:Good Clinical Practice for Medical Devices
3、Good Clinical Practice for Medical DevicesChapter 1Chapter 1General provisionsGeneral provisionsArticle 1Article 1The Practice is formulated in accordance with theRegulations on theSupervision and Administration of Medical Devicesin order to furtherstrengthen the management of clinical trials of med
4、ical devices,protect therights and benefits of trial subjects and assure the clinical trial procedurestandard,truthful,scientific,reliable and traceable.ArticleArticle 2 2All the clinical trials of medical devices within the territory of thePeoples Republic of China shall be conducted according to t
5、he practice.ThePractice covers the whole procedure of clinical trial of medical devices,including the protocol design,conduction,monitoring,audit,inspection,collection of data,record,analysis and summary and report of clinical trial,etc.Article 3Article 3Clinical trial of medical devices mentioned i
6、n this Practice refers to theprocess of confirming and verifying the safety and efficacy of the medicaldevice intended to apply registration under normal condition in qualifiedclinical trial institutions of medical devices.ArticleArticle 4 4 Clinical trials of medical devices shall comply with the p
7、rinciple oflegal,ethic and science.ArticleArticle 5 5 Food and drug regulatory authority above province level areresponsible for the supervision and management of clinical trails of medicaldevices.ThecompetentdepartmentofNationalHealthandFamilyPlanningCommission shall strengthen the management of cl
8、inical trails of medicaldevices within the scope of its duties.Food and drug regulatory authority and the competent department of NHFPCshall establish the information notification system on quality management ofmedical device clinical trials and strengthen the information notification on the专业医疗器械咨询
9、维康嘉业网址:www.vicon- 邮箱:approval for conducting clinical trial of Class III medical devices and the medicaldeviceslistedinthemanagementcatalogoflarge medical equipmentcollocation in China and the data of the supervision and management onrelevant clinical trial.Chapter IIChapter IIPreparation before cli
10、nical trialsPreparation before clinical trialsArticleArticle 6 6There should be sufficient scientific basis and clear trial purpose toconduct clinical trials of medical devices,and the expected benefits and risks tothe health of subjects and public shall be weighed,the expected benefitsshould exceed
11、 the possible damage.Article 7Article 7Before clinical trial,the sponsor shall complete the pre-clinical studyof investigational medical devices,including the design of products(structureand composition,working principle and mechanism of action,intended use,application scope and applicable technical
12、 requirements)and quality inspection,animal trial and analysis report,etc,and the results shall support the clinicaltrial.The results of quality inspection include report of self-inspection and thequalified report for registration inspection issued by a qualified inspectionagency within one year.Art
13、icle 8Article 8 Before clinical trial,the sponsor shall prepare adequate investigationalmedical devices.The development of investigational medical devices shall meetrelevant requirements of quality management system of medical devices.Article 9Article 9 Clinical trials of medical devices shall be co
14、nducted in two or morethan two clinical trial institutions of medical devices.The selected trailinstitution shall be qualified clinical trial institution of medical devices and thefacilities and conditions shall meet the requirements for conducting clinicaltrials safely and effectively.The investiga
15、tor should have the professionalexpertise,qualifications and ability to undertake the clinical trial and shouldhave been trained.专业医疗器械咨询维康嘉业网址:www.vicon- 邮箱:Administrative measures for thequalification recognition of clinical trialinstitutions of medical devices shall be formulated separately by Ch
16、ina Foodand Drug Administration and National Health and Family Planning Commissionof China.ArticleArticle1010Beforeclinicaltrial,thesponsor,clinicaltrialinstitutionandinvestigator shall make a written agreement on trial design,quality control oftrial,division of responsibilities in the trial,the cos
17、t of clinical trials undertakenby the sponsor and the treatment principle of injuries that may occur in thetrial.Article 11Article 11 Clinical trials should be approved by ethics committee of clinical trialinstitutions.Medical devices listed in the directory of Class III medical deviceclinical trial
18、 shall also be approved by CFDA.Article 12Article 12 Before clinical trial,the sponsor should file to local food and drugregulatoryauthorityoftheprovince,theautonomousregionorthemunicipality directly under the Central Government.The food and drug regulatory authority accepting the filling should rep
19、ort thefiling situations to the food and drug regulatory authority and the competentauthority of NHFPC in the same level where the clinical trial institution islocated.Chapter IIIChapter IIIProtection of rights and benefits of trial subjectsProtection of rights and benefits of trial subjectsArticle
20、13Article 13Clinical trials of medical devices should be conducted in accordancewith the ethical principlesinWorld Medical Association Declaration of Helsinki.ArticleArticle 1414Ethical review and informed consent are the main measures toprotect the rights and benefits of subjects.Each party involve
21、d in the clinicaltrial shall undertake corresponding ethical responsibilities according to theirduties in the trial.专业医疗器械咨询维康嘉业网址:www.vicon- 邮箱:Article 15Article 15 The sponsor should avoid to cause undue influence or misleading tosubjects,clinical trial institutions and the investigator and other
22、clinical trialparticipants or related parties.Clinical trial institution and the investigator should avoid to cause undueinfluence and misleading to subjects,the sponsor and other clinical trialparticipants or related parties.Article 16Article 16 The sponsor,clinical trial institution and the invest
23、igator shall notexaggerate the compensation measures for participating in clinical trials andmislead the subjects to participate in clinical trials.ArticleArticle1717 Before clinical trial,the sponsor shall submit the followingdocuments to ethics committee through the investigator and the management
24、department of medical device clinical trial of clinical trial institution:(1)Protocol of clinical trial;(2)Investigators brochure;(3)Text of informed consent form and any other written documents provided tosubjects;(4)Procedural documents for recruiting subjects and publicity;(5)Text of case report
25、form;(6)Self-inspection report and the inspection report for product registration;(7)Resumes,professional expertise,ability,training of the investigator andother documents to prove qualifications;(8)Overview of the facilities and conditions of clinical trial institution meetingtrial;(9)Declaration t
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