2015年医疗器械临床评价技术指导原则.docx

《2015年医疗器械临床评价技术指导原则.docx》由会员分享，可在线阅读，更多相关《2015年医疗器械临床评价技术指导原则.docx（25页珍藏版）》请在淘文阁 - 分享文档赚钱的网站上搜索。

1、AnnexTechnical Guidelines for Clinical Appraisal of Medical Devices Drafting objective Clinical appraisal of medical devices is the process implemented by registration applicant to identify whether the product fulfills usage requirements and application scope according to information concerning clin

2、ical documents, clinical experiences data, clinical trials and so on. This guidelines is intended to provide technical guide for registration applicant to carry out clinical appraisal as well as for the food and drug administration authorities to review clinical appraisal documents . Laws and regula

3、tions basis () “Medical devices management regulations”No. 650 decree of the state council; () “Medical devices registration management specifications” No. 4 decree of the state council; () Relevant specifications for clinical trial quality management of medical devices. Application scope This guide

4、lines is applicable to clinical appraisal of class and class medical devices when they are applied for registration. It is not applicable to clinical appraisal of in vitro diagnostic (IVD) reagents administrated as medical devices. If there is clinical appraisal technical guidelines for specific pro

5、duct, the corresponding clinical appraisal should follow relevant requirements of it. Basic principleClinical appraisal should be comprehensive as well as objective and corresponding data should be collected by various means such as clinical trials and so on. Clinical performance and safety data col

6、lected in clinical appraisal process should be included in analysis no matter it is positive or negative. Clinical appraisal depth and scope as well as data type and data quantity required should be compatible with design feature, key technology, application scope and risk level of the product while

7、 they should be also compatible with level and degree of non-clinical research.Clinical appraisal should confirm clinical application information concerning application scope(such as applicable people, applicable parts, contact manner with human body, indications, disease level and stage, applicatio

8、n requirements and application environment, etc), use method, contraindications, prevention measures and warning ,etc. Registration applicant should draw the following conclusion through clinical appraisal: the product has the expected performance in normal use; the risk of product is acceptable com

9、pared with expected benefits; the clinical performance and safety of product are both supported by proper evidences. . Clinical appraisal requirements for the product listed in catalogue of medical devices exempted from clinical trial.For the product listed in Catalogue of medical devices exempted f

10、rom clinical trial, registration applicant needs to submit documents of comparison between relevant information of declared product and the content included in the catalogue as well as comparison explanation for declared product and the medical devices included in the catalogue which have already ac

11、quired domestic registration permission. The specific clinical appraisal documents required to be submitted is as follows:() Submit documents of comparison between relevant information of declared product and the content included in catalogue; ()Submit comparison explanation for declared product and

12、 the medical devices included in the catalogue which have already acquired domestic registration permission. Comparison explanation should include Comparison form for declared product and the medical devices in the catalogue which has already acquired domestic registration permission (refer to annex

13、 1) and corresponding supportive documents.The above-mentioned submitted documents should prove the equivalence between declared product and the product listed in the catalogue. If equivalence between declared product and the product listed in the catalogue cannot be proved, corresponding jobs shoul

14、d be carried out according to other requirements in this guidelines. .Requirements for analysis and appraisal with data from clinical trial and clinical use of the same variety medical devices. ()The same variety medical devices1 Definition of the same variety medical devicesThe same variety medical

15、 devices are the domestic registered products which are identical to the declared product in the aspects of basic principle, structure composition, manufacturing material(it refer to the manufacturing material in contact with human body for active products), manufacturing technology, performance req

16、uirements, safety appraisal, implemented national/professional standards, intended application and so on.If the difference between declared product and the same variety medical devices has no adverse influence on product safety and effectiveness, they can be judged as basic equivalent. 2.Judgment of

17、 the same variety medical devicesWhen analysis and appraisal is implemented with data from clinical trial and clinical use of the same variety medical devices to prove the safety and effectiveness of medical devices, registration applicant should compare the declared product with one or several medi

18、cal devices of the same variety to prove the equivalence of them.The items for comparison with the same variety medical devices should include but not limit to the items in annex 2. The comparison content includes qualitative and quantitative data, verifying and confirming result. Homogeny and diffe

19、rences between both of them should be described in details while it should be verified and/or determined whether there is adverse influence on product safety and effectiveness due to difference by using the data of declared product itself, such as non clinical research data of the declared product,

20、clinical documents data, clinical experiences data and data of clinical trial implemented in China which is intended for difference. The corresponding data collection and analysis as well as appraisal should fulfill requirements in clause () and clause () as well as corresponding annexes. Clinical t

21、rial should fulfill relevant requirements of clinical trial quality management regulations. Registration applicant should provide comparison information in form of list( refer to annex 3 for format). If there are items which are not applicable, reason for inapplicability should be explained. () Appr

22、aisal approach Detailed appraisal approach is shown in annex 4. ()Collection of data for clinical trial and clinical use of the same variety medical devices Data from clinical trial and clinical use (simplified as clinical data in following text) can come from scientific documents published in China

23、 and/or overseas as well as corresponding data acquired legally ,including clinical documents data and clinical experiences data. Registration applicant can select proper data source and collection method according to specific situation of product. 1. Collection of clinical documents data Collection

24、 of clinical documents data should retrieve the documents precisely and comprehensively. Refer to annex 5 for documents retrieval and selection requirements. Before documents retrieval and selection is carried out, documents retrieval and selection scheme (refer to annex 6 for content and format) sh

25、ould be formulated. After documents retrieval and selection is completed, documents retrieval and selection report (refer to annex 7 for content and format) should be drafted. Clinical documents retrieval and selection should have repeatability. Documents retrieval and selection staff should have co

26、rresponding professional knowledge and practical experiences. 2. Collection of clinical experiences dataCollection of clinical experiences data should include collection of data concerning implemented clinical trials, adverse events, correction measures related to clinical risk and so on.(1) Collect

27、ion of the completed clinical research dataAccording to its design type, clinical research can be classified as perspective study, retrospective study , randomized controlled study, non randomized controlled study, single group study case-reporting and so on.Registration applicant should collect and

28、 provide opinions of ethics committee(if applicable), clinical research scheme and clinical research report.(2) Collection of adverse event dataRegistration applicant should collect the adverse events data included in complaints and adverse events database established by registration applicant itsel

29、f and the databases issued by administration authorities of various countries, such as Information bulletin of adverse events for medical devices and Express news for medical devices vigilance issued by China Food and Drug Administration, The Manufacturer and User Facility Device Experience(MAUDE) o

30、f FDA, Medical Device Alert (MDA) of Great Britain and so on.Registration applicant should provide information concerning complaints and adverse events quantity for the same variety medical devices, cause classification of complaints and adverse events, complaints and adverse events quantity for dif

31、ferent cause classification, whether complaints and adverse events are related to the product and so on. For the severely adverse events, detailed information concerning event description, cause analysis and handling method, etc should be provided in form of list.For the declared product, detailed i

32、nformation concerning market available time, accumulated sales , severely adverse events handling result and so on should be provided. (3) Collection of data of correction measures concerning clinical riskRegistration applicant should provide detailed information of correction measures concerning cl

33、inical risk(such as recalling, bulletin, warning and so on) for the same variety medical devices, the adopted risk control measures and so on. ( ) Clinical data analysis and appraisal for the same variety medical devices1. Data quality appraisalRegistration applicant should rank the data involved in

34、 analysis according to public acknowledged appraisal standard for clinical evidence levels (such as appraisal standard for clinical evidence levels drafted by Oxford Centre for Evidence Based Medicine). For part of the clinical data which is not applicable to be used in product effectiveness apprais

35、al, it can be used in product safety appraisal if possible.2. Data sets establishment The collected clinical data can be summarized into several data sets according to data type and data quality. Registration applicant can also establish data set respectively according to different appraisal objecti

36、ves, for example, the performance and/or safety for some products varies due to ethnic groups difference, so that Chinese population data set can be established for the appraisal of the product performance and/or safety for Chinese population using.3. Data statistics and analysis Proper data analysi

37、s method should be chosen for statistics and analysis of different data sets. Analysis methods for data set consisted of multiple research results include qualitative analysis and quantitative analysis .4. Data appraisalBy summarizing analysis result of different data-sets, appraisal for declared pr

38、oduct can be carried out to identify whether expected performance can be achieved in normal use condition and whether the product risk is acceptable compared with the expected benefits. () Clinical appraisal report Clinical appraisal report needs to be drafted after clinical appraisal is finished (r

39、efer to annex 8 for format) and be submitted as clinical appraisal documents when registration is applied . Requirements for clinical trial For the medical devices which have their clinical trials implemented in China, the clinical trials should be carried out in qualified clinical trial institute a

40、ccording to requirements of medical devices clinical trial quality management regulations. When registration applicant applies for registration, clinical trial scheme and clinical trial report should be submitted.For the imported medical devices which have overseas clinical trials, if the clinical t

41、rials fulfill requirements in relevant laws and regulations of China , such as requirements for sample quantity , contrast group selection, appraisal indexes and principle , effectiveness appraisal indexes , while registration application is carried out, registration applicant can submit the clinica

42、l trial documents which are submitted to overseas medical administration authorities when the product is put into overseas market. The documents should at least include opinions of ethics committee, clinical trial scheme and clinical trial report. Applicant should also submit relevant supportive doc

43、uments which demonstrate whether there is product clinical performance and/or safety difference due to ethnic groups difference .For the medical devices listed in Catalogue for Class III medical devices needing clinical trial approval, clinical trials should be carried out in China.Annexes: 1 Compar

44、ison form for declared product and the medical devices in the catalogue which have gotten domestic registration permission. 2. Comparison items of declared product and the same variety medical devices. 3. Format of comparison form for declared product and the same variety medical devices4. Approach

45、of analysis and appraisal with data from clinical trial and clinical use of the same variety medical devices. 5. Documents retrieval and selection requirements 6. Documents retrieval and selection scheme 7. Documents retrieval and selection report 8. Report of analysis and appraisal by using data fr

46、om clinical trials and clinical use of the same variety medical devices Annex 1 Comparison form for declared product and the medical devices in the catalogue which have acquired domestic registration permission Comparison itemsMedical devices in catalogueDeclared productDifferencesSummary of support

47、ive documentsBasic principle(operation principle/action mechanism)Structure compositionProduct manufacturing material or manufacturing material in contact with human body Performance requirements Sterilization/disinfection method Application scopeUse methodNote: comparison items can be increased acc

48、ording to specific situation Annex 2 Comparison items of declared product and the same variety medical devices (Passive medical devices)Passive medical devicesComparison items1. Basic principle2. Structure composition 3. Manufacturing technology4. Manufacturing material(such as material grade, animal derived materials, allograft material, ingredients, medicine ingredients, bioactive substances ,implemented standards and so on)5.Performance requirements 6. Safety appraisal(such as biocompatibility ,bio-safety and so on)