2023年资料7临床评价报告模板2.docx

资料-7--临床评价报告模板 篇一：资料-7--临床评价报告模板 医疗器械临床评价报告 （资料-7） XXXXXXXXXXX 临床评价报告 一、 概述 我公司（XXXXXXXX）研制开发的XXXXXXXXXXX供临床XXXXXXX用。 根据医疗器械分类目录的规定，XXXXXXXXXXX为 第二类注射穿刺器械，类别代号为：6815。目前国内已有多个同类产品注册上市，广泛应用多年，其临床上的平安性、有效性早已得到确认。 二、 产品设计 本产品XXXXXXXX。 三、 工作原理 XXXXXXXXXXX的工作原理是按无菌操作要求，撕开注射器单包装，去掉注射器保护套，抽取、溶解或配制药液用。 四、 市场概况 现在市场销售的同类产品主要有XXXXXXXXXXX等。这些产品在使用过程未发生过任何意外事故的报道；其中本公司的XXXXXXXXXXX产品与国内厂家工作原理根本相同。XXXXXXXXXXX为列入免于进行临床试验的医疗器械目录产品，现将申报产品与目录所述内容进行比照以判定申报产品是否为列入目录产品。 申报产品与目录产品的比照表 注：支持性资料是指申报产品与目录产品的差异性对申报产品的平安有效性不产生影响的理由和依据，可以附件的形式提供。 第 3 页 共 9 页 五、 比照产品选择 现以与同类已上市产品进行比照评价，说明我公司产品在临床使用的平安性、有效性。 选择与我司产品类似，且同样按二类医疗器械产品注册的上海金塔医用器材XXXXXXXXXXX。 六、 主要比照情况说明 第 4 页 共 9 页 第 5 页 共 9 页 篇二：Clinic Evaluation Report Template 临床评估报告模板 CLINICAL EVALUATION REPORT 临床评估报告 For Product: XXXX 产品：XXXX Document No. XXXXXXXX 文件编号 Version: 1.0 版本: Date: 2023-05-17 日期: Author: 作者: Reviewed by: 审阅: Approved by: 批准: Table of Content 目录 Page页码 1. General details总述 ............................................................................................ 3 2. Description of the device and its intended application器械描述和预期用途 .. 3 3. Intended therapeutic and/or diagnostic indications and claims 预期治疗和/或诊断说明和要求 ............................................................................... 3 4. Context of the evaluation and choice of clinical data types 评估背景和临床数据类型的选择 ............................................................................. 3 5. Summary of the clinical data and appraisal总结临床数据和评价 .................... 4 6. Data analysis数据分析 ........................................................................................ 5 6.1. Performance性能 ................................................................................................ 5 6.2. Safety平安 ........................................................................................................... 5 6.3. Product Literature and Instructions for Use产品文献和使用说明 .................... 5 7. Conclusions结论................................................................................................................................................ 6 1. General details 总述 State the proprietary name of the device and any code names assigned during device development. Identify the manufacturer(s) of the device. 描述器械的商品名，以及在器械研发过程中使用的任何编码。识别器械的生产商。 2. Description of the device and its intended application 器械描述和预期用途 Provide a concise physical description of the device, cross referencing to relevant sections of the manufacturer’s technical information as appropriate. The description should cover information such as: materials, including whether it incorporates a medicinal substance (already on the market or new), tissues, or blood products; the device components, including software and accessories; mechanical characteristics; and others, such as sterile vs. non-sterile, radioactivity etc. State the intended application of the device, single use/reusable; invasive/non invasive; implantable; duration of use or contact with the body; organs, tissues or body fluids contacted by the device. Describe how the device achieves its intended purpose. 对该器械进行简明的物理描述，适当参照生产商技术信息的相关章节。此描述应包含的信息，如： 材料，包括是否含药（已经上市的或全新的）、组织或血液产品； 器械组成，包括软件和附件； 机械特征；和 其他，如灭菌，非灭菌，放射能等等。 描述器械的预期用途，一次性使用/屡次使用；侵入/非侵入；可植入；使用持续时间或与人体接触；器械接触的器官，组织或体液。 描述器械如何到达它的预期用途。 3. Intended therapeutic and/or diagnostic indications and claims预期治疗和/或 诊断说明和要求 State the medical conditions to be treated, including target treatment group and diseases. Outline any specific safety or performance claims made for the device 描述使用时的医学条件，包括目标治疗群体和疾病。概述器械的任何特殊平安或性能要求。 4. Context of the evaluation and choice of clinical data types评估背景和临床数 据类型的选择 Outline the developmental context for the device. The information should include whether the device is based on a new technology, a new clinical application of an existing technology, or the result of incremental change of an existing technology. The amount of information will differ according to the history of the technology. Where a completely new technology has been developed, this section would need to give an overview of the developmental process and the points in the development cycle at which clinical data have been generated. For long standing technology, a shorter description of the history of the technology (with appropriate references) could be used. Clearly state if the clinical data used in the evaluation are for an equivalent device. Identify the equivalent device(s) and provide a justification of the equivalency, cross-referenced to the relevant non-clinical documentation that supports the claim. 概述器械的开展历史。内容应包括器械是否基于新技术，是否基于现有技术的新临床应用，或者是现有技术增量变化的结果。根据该技术的历史，信息量将有所不同。如果是一项全新技术开展起来，本章须概述开展过程和开展周期中产生临床数据的节点。如果是常规技术，须简短描述该技术的历史（须适当引用）。明确指出，评估中使用的临床数据是否来自等同器械。识别等同器械，并给出等同的理由，参照相关非临床文献，以支撑观点。 State the Essential Requirements relevant to the device in question, in particular, any special design features that pose special performance or safety concerns (e.g. presence of medicinal, human or animal components)