Technical Guidance On Clinical Evaluation Of Medical Devices
AnnexTechnical Guidance on Clinical Evaluation of Medical DevicesI. PurposeThe clinical evaluation of medical devices is the assessment procedure conducted byregistration applicants to validate whether the application requirements or intended use of thedevice(s) under application can be achieved based on clinical literatures, clinical experiencedata and information gathered from the clinical trial(s). This Guidance is to provide technicalguidance to registration applicants for conducting clinical evaluation and to food and drugadministrative authorities for reviewing the clinical evaluation data.II. Legal BasisI.Regulation on the Supervision and Administration of Medical Devices (Decree of theState Council No. 650);II.Measures for the Administration of Registration of Medical Devices (Decree No. 4 ofChina Food and Drug Administration); andIII.Related provisions on clinical trial quality control of medical device.III. Scope of ApplicationThis Guidance is applicable to the clinical evaluation for registration application of Class II andClass III medical devices, and is not applicable to the clinical evaluation of in-vitro diagnosticsadministrated as medical devices. In case there is technical guidance on clinical evaluation ofspecific medical device product available, it should be followed for the clinical evaluation ofthe corresponding product.IV. Basic PrinciplesThe clinical evaluation should be thorough and objective. Corresponding data should becollected by multiple means including clinical trial(s). Clinical performance and safety datacollected during clinical evaluation (including both favorable and unfavorable data) should beincluded in the analysis. The depth and extent of clinical evaluation and non-clinical studies,and required data type and volume should be appropriate to the product design features,critical technologies, intended use, and risks of the device.A clinical evaluation should verify the clinical claims made about the device, including theapplication of the device (e.g., target treatment group, the site of application to/in the body,method of contact with human body, indications, severity and state of the disease, applicationrequirements and operation environment, etc.), method of application, contraindications,precautions, and warnings, etc.— 1 —啊
The registration applicant should be able to reach the following conclusions through clinicalevaluation: the product can achieve the expected performance in normal use conditions; theproduct risks are acceptably balanced with expected benefits; clinical performance and safetyof the product are both supported by sufficient evidence.V. The Requirements of Clinical Evaluation for the Products Listed in the Catalogue of MedicalDevices Exempted from Clinical TrialFor the products listed in The Catalogue of Medical Devices Exempted from Clinical Trial(hereinafter referred to as “the Catalogue”), the registration applicant should submit thecomparison summary of relevant information of the device under application with thecorresponding information in the Catalogue, and the comparison description of the deviceunder application to the equivalent medical device listed in the Catalogue which has alreadyobtained domestic registration approval. Specific data for the clinical evaluation should include:I.Comparison between the device under application and corresponding information inthe Catalogue;II.Comparison between the device under application and an equivalent medical device inthe Catalogue that has obtained domestic registration approval. The comparisondescription should include Comparison Table of the Device under Application and anEquivalent Medical Device Listed in the Catalogue that has Obtained DomesticRegistration Approval (see Annex 1) and relevant supporting documents.The above submitted documentation should be able to prove equivalence between the deviceunder application and the corresponding device listed in the Catalogue. If this is not the case,the application procedures should be followed according to other relevant requirementsdefined in this Guidance.VI. Requirements for Clinical Analysis and Evaluation Based on Data Obtained from ClinicalTrial(s) or Clinical Application of the Equivalent Medical DeviceI.Equivalent Medical Device1. Definition of Equivalent Medical DeviceThe equivalent medical device refers to the device that has obtained domesticregistration approval and is substantially equivalent to the device underapplication in aspects of basic principles, structural composition, manufacturingmaterials ( manufacturing materials that come into contact with the human bodyfor active devices), manufacturing process, performance requirements, safetyevaluation, conformed national /industry standards and expected use.The device under application can be considered as substantially equivalent with— 2 —啊
the equivalent medical device in the case that no adverse effects on the safetyand effectiveness of the device are caused by the differences between the twodevices.2. Determination of Equivalent Medical DeviceIn order to prove the safety and effectiveness of the device under applicationutilizing the data from the clinical application experience or clinical trial(s) of theequivalent medical device, the applicant needs to compare the device underapplication with one or more equivalent medical device(s) and prove thesubstantial equivalence between the devicesThe items involved in the comparison with the equivalent medical device shallinclude, but be not limited to those listed in Annex 2, including the qualitativeand quantitative data, and the verification and validation results. The similaritiesand differences between the two products should be described in detail. It shallbe verified and/or confirmed based on the data of the device under applicationwhether the differences will result in any negative impact on the safety oreffectiveness of the device. This data includes that obtained from its non-clinicalstudy, clinical literature, clinical experience, and clinical trials conducted in Chinato address any differences. The collection, analysis, and evaluation of therelevant data should meet the requirements specified in sections (III) and (IV), aswell as the corresponding annexes. Clinical trials should be consistent withrelative requirements of Quality Management Practices.The applicant should provide comparative information in the form of a table (seeAnnex 3 for the format). For specific products with inapplicable items/ items thatdo not apply, reasons should be provided.II.Evaluation PathSee Annex 4 for the details of evaluation path.III.Collection of Data from Clinical Trial(s) or Clinical Application of Equivalent MedicalDeviceThe data from clinical trial(s) or clinical application (hereinafter abbreviated as clinicaldata) can be obtained from public scientific literature released in China and/or overseasand other relative data acquired legally, including clinical literature data and clinicalexperience data. The registration applicant can select the appropriate data sources andmethods of collection according to the characteristics of the product.1. Collection of Clinical Literature DataDuring thecollection of clinical literaturedata, theaccuracyandcomprehensiveness of the literature should be guaranteed. The recommendedliterature search and screening elements are in Annex 5. The literature search— 3 —啊
and screening protocol should be prepared prior to any literature search (seeAnnex 6 for the content and format). After the literature search and screening, areport on the literature search and screening must be compiled (see Annex 7 forthe content and format). The clinical literature search and screening should berepeatable. The personnel in charge of literature search and screening should beequipped with appropriate professional knowledge and practical experience.2. Collection of Clinical Experience DataCollection of clinical experience data should include collection of data fromcompleted clinical studies, adverse events, and corrective action related toclinical risks.1) Collection of Data from Completed Clinical StudiesAs far as design is concerned, clinical studies can be divided intoprospective study, retrospective study, randomized controlled trials, nonrandomized controlled trials, single-arm studies and case reports, etc.The applicant is required to collect and submit the opinions from EthicsCommittee (if applicable), the clinical research plan and the clinicalresearch report.2) Collection of Adverse Events DataThe registration applicant should collect the corresponding adverseevent data from the complaints and adverse events database establishedby himself, and the adverse events database issued by the regulatoryauthorities of all nations, such as the Medical Device Adverse EventsBulletin and Alert Newsletter of Medical Devices issued by China Foodand Drug Administration, the Manufacturer and User Facility DeviceExperience Database (MAUDE) of U.S. Food and Drug Administration andthe British Medical Device Alert (MDA).The registration applicant should provide the following informationrelated to the equivalent medical device: number of complaints andadverse events, reasons classification of complaints and adverse events,number of complaints and adverse events classified by different reasons,and the relationship of the adverse events with the product. For seriousadverse events, the specific information such as event description, causeanalysis, and corrective solutions should be summarized in the form of atable.For the device under application, specific information such as the timeon market in different countries, accumulated sales and outcome ofserious adverse events should also be provided.— 4 —啊
3) Data Collection of Corrective Measures Related to Clinical RisksThe applicant should collect and provide specific information oncorrective measures associated with clinical risks of the equivalentmedical device (e.g. recall, announcements, warnings, etc.), and the riskcontrol measures that have been taken.IV.Analysis and Evaluation of Clinical Data from Equivalent Medical Device1. Quality Evaluation of DataThe registration applicant should classify the data involved in the analysis inaccordance with generally accepted evaluation criteria of clinical evidence level(e.g. the Evaluation Criteria of Clinical Evidence level established by OxfordCenter for Evidence-based Medicine). The clinical data found to be unsuitable forvalidity evaluation can be applied to the safety evaluation of the device ifapplicable.2. Establishment of Data SetsThe collected clinical data can be grouped into several data sets based on theirdifferent data type and data quality. The registration applicant may also createdata sets according to different evaluation purposes. For example, if ethnicdifferences exist within the clinical performance and/or safety of certainproducts, the Chinese subgroup data sets can be established for evaluating thesafety and /or efficacy of the product in Chinese population.3. Statistical Analysis of DataThe appropriate data analysis methods should be adopted to conduct statisticalanalysis in different data sets. For the data sets with multiple study results, theanalysis method should include the qualitative analysis and quantitative analysis.4. Data EvaluationBased on the analysis results of different data sets, the applicant should evaluatewhether the device under application could reach the expected performance innormal conditions of use, and whether the risks are acceptable compared to theintended benefits.V.Clinical Evaluation ReportA clinical evaluation report should be prepared after completion of the clinical evaluation(see Annex 8 for the format), and should be submitted as a part of the clinical evaluationmaterials during registration application.VII. Requirements for Clinical TrialsFor medical devices with clinical trials conducted in China, these trials should be conducted bya qualified clinical trial institution in accordance with Quality Management Regulations forClinical Trial(s) of Medical Devices. When applying for registration, the registration applicant— 5 —啊
should submit clinical trial protocol and report.For imported medical devices with clinical trials conducted overseas, the registration applicantcan submit the clinical trial data provided to foreign authorities on medical devices during itsmarketing approval, as long as such trials comply with relevant Chinese regulations andrequirements defined in technical guidance for registration, e.g. sample size, control groupselection, evaluation indexes and principles, and efficacy evaluation indexes. Such data shouldat least contain opinions of the ethics committee, clinical trial protocol, and the clinical trialreport. The applicant also needs to provide supporting documents that demonstrate anyethnic difference of the product concerning clinical performance and/or safety.For medical devices listed in Category III Medical Devices Subject to Clinical Trial Approval,clinical trials in China are required.List of Annexes:Annex 1. Comparison Table of the Device under Application and an EquivalentMedical Device Listed in the Catalogue that has Obtained Domestic RegistrationApprovalAnnex 2. Items Compared between Device under Application and the EquivalentMedical DeviceAnnex 3. Format of Comparison Table of Device under Application and theEquivalent Medical DeviceAnnex 4. The Analysis and Evaluation Path Based on Data from Clinical Trials orClinical Application of Equivalent Medical DevicesAnnex 5. Requirements of Literature Search and ScreeningAnnex 6. Literature Search and Screening ProtocolAnnex 7. Literature Search and Screening ReportAnnex 8. The Analysis and Evaluation Report Based on Data from Clinical Trials orClinical Application of Equivalent Medical Devices— 6 —啊
Annex 1Comparison Table of the Device under Application and anEquivalent Medical Device Listed in the Catalogue that hasObtained Domestic Registration ApprovalItemsMedical DevicesDevice underin the CatalogueApplicationDifferencesBasic Principles( Working Principles /Mechanism of Action)Structural CompositionManufacturing materialsor Manufacturingmaterials in contact withhuman bodyPerformanceRequirementsSterilization /Disinfection MethodsScope of ApplicationMethod of Application NOTE: More items can be added to the table based on the actual situation.— 7 —啊Summary ofSupporting Data
Annex 2Items Compared between Device under Application and theEquivalent Medical Device(Passive Medical Devices)ItemsPassiveMedicalDevices1.Basic Principles2.Structural Composition3.Manufacturing Process4. Manufacturing materials (including material grades, animal-derived materials,allograft materials, ingredients, pharmaceutical ingredients, bioactive substances,and required standards, etc.)5. Performance Requirement6. Safety Evaluation (e.g. biocompatibility, biological safety, etc.)7. Conformed National /Industry Standards8.Scope of Application:（1）Target Treatment Group（2）Site of Application to/in the Body（3）Mode or Method of contact with the Human Body（4）Indication（5）Stage and Severity of Disease（6）Operational Environment9. Method of Application10.Contraindications11. Precautions and Warnings12. Delivery Status13. Sterilization / Disinfection Methods14. Packaging15. Label16. Product Specification— 8 —啊
Items Compared between Device under Application and theEquivalent Medical Device(Active Medical Devices)ItemsActiveMedicalDevices1. Basic Principles（1）Working Principles（2）Mechanism of Action2.Structural Composition（1）Product Composition（2）Core Components3. Manufacturing Process4. Manufacturing materials in contact with human body (including material grades,animal-derived materials, allograft materials, ingredients, pharmaceuticalingredients, bioactive substances, and required standards, etc.)5. Performance Requirement（1）Performance Parameters（2）Function Parameters6. Safety evaluation (e.g. biocompatibility, biological safety, electrical safety,radiation safety, etc.)7. Core Function8.Conformed National /Industry Standards9.Scope of Application:（1）Target Treatment Group（2）Site of Application to/in the Body（3）Methods Contacting with Human Body（4）Indications（5）Stage and Severity of Disease（6）Operational Environment10. Method of Application11. Contraindications12. Precautions and Warnings13. Sterilization / Disinfection Methods14. Packaging15. Label16. Product Specification— 9 —啊
Annex 3Format of Comparison Table of Device under Application and theEquivalent Medical DeviceItemsEquivalent MedicalDevicesDevice on NOTE: All the items listed in Annex 2 should be included.— 10 —啊DifferenceSummary ofSupporting Data
Annex 4The Analysis and Evaluation Path Based on Data from ClinicalTrials or Clinical Application of Equivalent Medical DevicesMedical DevicesAre there anydifferences fromequivalent medicaldevices?NoYesCan it be proven that the differences have nonegative impact on the safety oreffectiveness of the device based on dataobtained from its non-clinical studies, and /orclinical literature data, and /or clinicalexperience data, and /or clinical trial dataconducted in China to address anydifferences?Collect and analyzeclinical literatureand/or clinicalexperience data ofequivalent medicaldevicesYesNoGenerate theclinical evaluationreport andcomplete theclinical evaluationThe analysis and evaluation could notbe conducted through data obtainedfrom the clinical trial(s) or clinicalapplication of the equivalent device. Inthis case, the applicant needs to submitrelevant clinical trial data as required.— 11 —啊
Annex 5Requirements of Literature Search and ScreeningI. Search DatabaseThe registration applicant is required to choose a search database based on the specific characteristicsof the device under application/ the equivalent medical device (e.g. design features, scope ofapplication, etc.), and discuss his reasons in the protocol. The selection of the database should becomprehensive, and below are some examples of database types:1. Science database: such as the Chinese Journal Full-text Database, Index Medicus (Medline) ofthe United States and EMBASE (EM) of Netherlands, etc.;2. Clinical Trial Database: such as Cochrane Central Register of Controlled Trials (CENTRAL),ClinicalTrials.gov, etc.;3. Database of Systematic Reviews: such as the Cochrane Library, etc.;4. Professional Database: such as MEDION and osteoarticular registration database, etc.II. Search Methods, Search Terms and Logical Relationship of Search TermsIn order to find comprehensive and accurate clinical literature of the device under application/ theequivalent medical device, the selection of search paths, search terms and the logical relations amongsearch terms should be considered when developing the scientific search strategy. The common searchmethods include subject words search, keywords search, abstract search, and full text search. Searchterms should be adapted to the selected search methods, and factors such as common name,commercial name, manufacturer, basic principles, structural composition, manufacturing materials,design features, key technology and scope of application shall be considered. When conducting thelogical matching of search terms, the proper logical operators should be chosen to express the logicalrelationship between the search terms, such as using the logical word "OR" to expand the search rangeand "AND" to narrow it. The selection reason for the search methods, search terms and logicalrelationship of search terms should be explained in the search protocol.III. Procedure and Criteria of Literature ScreeningFor the further screening of searched literatures, the steps as specified in Diagram 1 should befollowed. The registration applicant, based on the titles and abstracts of literatures, shall screen theliteratures that possibly satisfy the requirements
The clinical evaluation of medical devices is the assessment procedure conducted by registration applicants to validate whether the application requirements or intended use of the device(s) under application can be achieved based on clinical literatures, clinical experience data and information gathered from the clinical trial(s). .File Size: 579KB
must include a clinical evaluation in accordance with Annex X. MDD 93/42/EEC clinical evaluation: not a one-time isolated activity Clinical evaluation is defined as the assessment and analysis of clinical data pertaining to a medical device in order to verify its clinical safety and performance when used as intended. Two key elementsFile Size: 864KB
Forensic Science Regulator GUIDANCE - GUIDANCE- GUIDANCE- GUIDANCE- GUIDANCE- GUIDANCE- GUIDANCE- GUIDANCE- FSR-G -206 Consultation Version Page 4 of 34 1. INTRODUCTION 1.1.1 For the purposes of this appendix, contamination is defined as "the introduction of DNA, or biological material containing DNA, to an exhibit at or after the point
The Clinical Program is administered by the Clinical Training Committee (CTC) under the leadership of the Director of Clinical Training (DCT) and the Associate Director of Clinical Training (ADCT). The program consists of three APA defined Major Areas of Study: Clinical Psychology (CP), Clinical Child Psychology (CCP), Clinical Neuropsychology .
The Clinical Laboratory Evaluation Program The Clinical Laboratory Evaluation Program (CLEP) administers the activities of the Clinical Laboratory Reference System and provides the oversight of over 1,000 clinical laboratories and blood banks, including out-of-state facilities that accept clinical specimens collected in New York State.
clinical data and clinical evaluation Devices may be at different points in their lifecycle (design and development, CE marking, maintenance of CE mark), with some requiring initial clinical evaluation and others clinical evaluation update May be difficult to ha
Annex X, Clinical Evaluation, Section 1.1b-1.1c “The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.” “The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance.File Size: 1MB
Clinical Guidance on Cannabis for Medical Use 1. Clinical Guidance 1.1. Aim This Clinical Guidance will form part of the Cannabis for Medical Use Access Programme, once . skin, and blood (monocytes, macrophages, B-cells and T-cells). The endocannabinoids that interact with these receptors appear to be involved in the .
A/ B. COM - SEMESTER I – GENERAL ENGLISH (2019- 20) University Paper Style (total 4 questions, 70 marks, 2.30 hours) Unit/s Topic/s No MarksQuestion style I Lessons Beautiful Minds (Gujarati Medium) Pinnacle (English Medium) Q. 1. 1 to 3 (a) Answer in brief - 3/5 (b) Write a short note - 1/3 (09) (08) II Q. 2. Poems 1 to 3 (a) Answer in brief - 3/5 (b) Write a short note - 1/3 (09) (08) III .
