无创血糖仪：注册路径指南与临床试验要求

2024-11-27 分类: 医疗资讯中心公司新闻 0

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随着科技的进步和医疗技术的不断创新，无创血糖仪正逐步迈向更精准、更智能、更易于操作的新阶段。它不仅仅是一个测量工具，更是连接患者、家属与医疗专业人员的桥梁，通过远程监控、数据分析等功能，构建起全方位、个性化的糖尿病管理体系。未来，无创血糖仪的应用将进一步拓宽，有望成为家庭健康监测、临床决策支持及公共卫生管理的重要工具，为全球数以亿计的糖尿病患者带来福音，开启糖尿病管理的新篇章。

With advancements in technology and continuous innovation in medical techniques, non-invasive blood glucose meters are gradually evolving towards a new stage of higher accuracy, intelligence, and ease of use. They are not just measurement tools but also bridges connecting patients, families, and medical professionals, establishing a comprehensive and personalized diabetes management system through remote monitoring and data analysis. In the future, the application of non-invasive blood glucose meters will further expand, potentially becoming important tools for home health monitoring, clinical decision-making support, and public health management, bringing blessings to hundreds of millions of diabetes patients worldwide and ushering in a new chapter in diabetes management.

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1、分类编码（The classification code.）：

无创血糖仪管理类别为III类；分类编码:07-03-00

The management category of non-invasive blood glucose meters is Class III; classification code: 07-03-00.

2、预期用途（Intended Use）：

1）日常血糖监测（

Daily blood glucose monitoring）

2）即时反馈与调整（

Immediate feedback and adjustment）

3）长期健康管理（

Long-term health management）

4）教育与意识提升（

Education and awareness raising）

5）远程医疗与数据共享（

Telemedicine and data sharing）

6）科研与临床研究（

Scientific research and clinical studies）

3、产品原理（Product Principle）：

无创血糖仪的产品原理主要基于以下几种技术，通过非侵入性的方式测量血糖水平，旨在提供便捷、舒适的血糖监测体验：

The product principle of non-invasive blood glucose meters is mainly based on the following technologies, which measure blood glucose levels in a non-invasive manner, aiming to provide a convenient and comfortable blood glucose monitoring experience:

1）光谱测量技术（Spectral measurement technology）

2）生物电极技术（Bio-electrode technology）

3）其他间接测量技术（Other indirect measurement technologies)

4）光声成像技术+AI智能技术(Photoacoustic imaging technology + AI intelligent technology)

4、产品优势(Product Advantages)：

1）便捷舒适(Convenient and comfortable)

2）快速准确(Fast and accurate)

3）智能互联(Intelligent connectivity)

4）节省成本(Cost-saving)

5）适用广泛(Widely applicable)

5、无创血糖监测产品宜参考的现行有效标准(The currently effective standards that non-invasive blood glucose monitoring products should refer to.)

标准编号 (Standard Numbers)	标准名称 (Standard Names)
GB 9706.1	医用电气设备第1部分：基本安全和基本性能的通用要求 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.15-2008	医用电气设备第1-1部分：安全通用要求并列标准：医用电气系统安全要求（如适用） Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (if applicable)
GB/T 14710	医用电器环境要求及试验方法 Environmental requirements and test methods for medical electrical equipment.
GB/T 16886.1	医疗器械生物学评价第1部分：风险管理过程中的评价与试验 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
GB/T 16886.5	医疗器械生物学评价第5部分：体外细胞毒性试验 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
GB/T 16886.10	医疗器械生物学评价第10部分：刺激与迟发型超敏反应试验 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity.
GB/T 16886.12	医疗器械生物学评价第12部分：样品制备与参照样品 Biological evaluation of medical devices - Part 12: Sample preparation and reference samples.
GB/T 16886.18	医疗器械生物学评价第18部分：材料化学表征 Biological evaluation of medical devices - Part 18: Chemical characterization of materials.
GB/T 14233.2	医用输液、输血、注射器具检验方法第2部分：生物学试验方法 Test methods for medical infusion, transfusion, and injection equipment - Part 2: Biological test methods.
GB/T 42062	医疗器械风险管理对医疗器械的应用 Application of risk management to medical devices.
GB/T 21416	医用体温计（如适用） Medical thermometer (if applicable).
YY 0785	临床体温计连续测量的电子体温计性能要求（如适用） Performance requirements for electronic clinical thermometers for continuous measurement (if applicable).
YY 9706.102	医用电气设备第1-2部分：基本安全和基本性能的通用要求并列标准：电磁兼容要求和试验 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility requirements and tests.
或or	或or
YY 0505	医用电气设备第1-2部分：安全通用要求并列标准：电磁兼容要求和试验 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility requirements and tests.
YY 9706.108	医用电气设备第1-8部分：基本安全和基本性能的通用要求并列标准：通用要求，医用电气设备和医用电气系统中报警系统的测试和指南（如适用） Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: Tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (if applicable).
或or	或or
YY 0709	医用电气设备第1-8部分：安全通用要求并列标准　医用电气设备和医用电气系统中报警系统的测试和指南（如适用） Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: Tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (if applicable).
YY 9706.111	医用电气设备第1-11部分：基本安全和基本性能通用要求-并列标准：在家庭护理环境中使用的医用电气设备和医用电气系统的要求 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
YY 9706.256	医用电气设备第2-56部分：用于体温测量的临床体温计的基本安全和基本性能专用要求 Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
YY 9706.261	医用电气设备第2-61部分：脉搏血氧设备的基本安全和基本性能专用要求（如适用） Medical electrical equipment - Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximetry equipment (if applicable).
或or	或or
YY 0784	医用电气设备医用脉搏血氧仪设备基本安全和主要性能专用要求（如适用） Particular requirements for the basic safety and essential performance of medical electrical equipment - Medical pulse oximeters (if applicable).

6、临床试验要求(Clinical trial requirements.)：

按照《医疗器械临床评价技术指导原则》，申请人应提供无创血糖监测产品的临床评价资料。除非无创血糖监测产品属于《决策是否开展医疗器械临床试验技术指导原则》第三部分中可考虑免于开展临床试验的情形，否则原则上申请人应通过临床试验路径开展临床评价。In accordance with the "Technical Guidance for Clinical Evaluation of Medical Devices", the applicant shall provide clinical evaluation materials for the non-invasive blood glucose monitoring product. Unless the non-invasive blood glucose monitoring product falls under the circumstances outlined in Part 3 of the "Technical Guidance for Deciding Whether to Conduct Clinical Trials for Medical Devices" where clinical trials may be considered waived, in principle, the applicant should conduct clinical evaluation through the clinical trial pathway.

1）可考虑免于开展临床试验的情形(Circumstances under which clinical trials may be considered waived.)

按照《医疗器械临床评价等同性论证技术指导原则》，申请人应通过分析评价同品种医疗器械的临床数据来确认无创血糖监测的安全性和有效性。In accordance with the "Technical Guidance Principles for Equivalence Evaluation of Medical Device Clinical Assessment", the applicant should confirm the safety and effectiveness of non-invasive blood glucose monitoring by analyzing and evaluating the clinical data of medical devices of the same type.

申请人可按照《接受医疗器械境外临床试验数据技术指导原则》的要求提供申报产品境外临床试验数据，结合其他资料和生产信息进行综合评价，确认无创血糖监测的安全性和有效性。The applicant may provide overseas clinical trial data for the declared product in accordance with the requirements of the "Technical Guidance for Accepting Overseas Clinical Trial Data for Medical Devices", and conduct a comprehensive evaluation in conjunction with other materials and production information to confirm the safety and effectiveness of non-invasive blood glucose monitoring.

2）通过临床试验数据进行分析、评价(Analyze and evaluate through clinical trial data.)

申请人可参考《医疗器械临床试验设计指导原则》来确认无创血糖监测的安全性和有效性。Applicants can refer to the "Guidance for Clinical Trial Design of Medical Devices" to confirm the safety and effectiveness of non-invasive blood glucose monitoring.

7、注册路径(Registration pathway.)：

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盟鸿医学在医疗器械临床试验领域表现卓越，不仅拥有了专业的知识背景，还拥有先进的技术成熟、经验丰富的专业团队，以及丰富的无创血糖仪临床经验。我们专注于为企业提供专业的专业知识检测与注册以及临床试验服务，旨在为企业发展提供全面的技术支持。

Hom Medicine excels in the field of medical device clinical trials, not only possessing profound professional knowledge but also having a mature and experienced team, as well as extensive clinical experience with non-invasive blood glucose meters. We specialize in providing enterprises with professional testing, registration, and clinical trial services, aiming to support their development and offer comprehensive technical assistance.

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微信号：hom_medical、18018710006 联系电话：18018716006

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