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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 the same variety medical devicesWhen analysis and appraisal is implemented with data from clinical trial
