鸿盟医学，作为医疗器械检测、临床试验及注册服务领域的资深专家，今日我们将目光聚焦于与公众健康密切相关的产品——血糖仪，共同探讨其在新时代背景下的发展趋势与结合监管要求。
HOM Medical, as a senior expert in the field of medical device testing, clinical trials and registration services, today we focus on the product —— blood glucose meter closely related to public health, to discuss its development trend in the new era and the regulatory requirements.
随着生活水平的提高，糖尿病已成为全球广泛关注的慢性健康问题。为此，国家对血糖监测产品的监管力度持续加强，以确保患者自测结果准确无误，从而有效控制病情。2024年新春期间，国家药品监督管理局及时发布了最新的《自测血糖系统注册申报数据原则》，为行业设定了新的标准与导向。
With the improvement of living standards, diabetes has become a chronic health concern worldwide. To this end, the national supervision of blood glucose monitoring products continues to strengthen to ensure the accuracy of patients self-test results, so as to effectively control the condition. During the Spring Festival of 2024, the National Medical Products Administration timely released the latest Principles for Registration and Application Data of Self-Testing Blood Glucose System, setting new standards and guidance for the industry.
对此，大家普遍关心的两大核心问题，鸿盟医学明确解答：
In this regard, the two core questions:
1.是否需要按照新国标进行检测？
1. Does it need to be tested according to the new national standard?
答案是肯定的。新国标的实施，强调更严格的质量控制和更高的安全标准，对于患者权益、增强产品竞争力市场维护具有必然意义。
The answer is yes. The implementation of the new national standard, emphasizing stricter quality control and higher safety standards, is of inevitable significance for the rights and interests of patients and to enhance the market maintenance of product competitiveness.
Refer to the test items and standards, please refer to the following table:
2.是否需要进行临床验证？
2. Is the clinical validation required?
临床验证必须是评估血糖仪及试纸准确性的关键步骤，通过科学、规范的临床试验流程，可以确保产品测量结果与医院实验室标准值的高度一致性，为患者提供可靠的结果的自我管理工具。
Clinical validation must be a key step in assessing the accuracy of blood glucose meter and dipstick. Through a scientific and standardized clinical trial process, it can ensure a high consistency of product measurements and hospital laboratory standard values, and provide reliable self-management tools for patients.
鸿盟医学，作为行业内的领先者，拥有丰富的血糖仪临床试验经验与成功案例。我们深知，在临床试验的时效性、数据收集与分析的准确性方面，每个细节都至关重要因此，我们承诺，将依托专业的团队、先进的设备以及高效严谨的流程，为贵公司提供从方案设计到提交的全方位、一站式服务，协助您的产品快速、接地气地完成注册申报，抢占市场先机。
HOM Medical, as a leader in the industry, has rich experience in clinical trials and successful cases of blood glucose meters. We know that in the timeliness of clinical trials, the accuracy of data collection and analysis, every detail is crucial, therefore, we promise, will rely on the professional team, advanced equipment and efficient rigorous process, for your company from the design to submit comprehensive, one-stop service, assist your products quickly, ground to complete the registration declaration, seize market opportunities.
如果您对我们的服务感兴趣，或希望进一步了解血糖仪相关的最新法规动态、技术挑战及解决方案，欢迎通过微信联系我们，共同开启一段互利共赢的合作旅程。期待与您相关，共筑健康未来！
If you are interested in our service, or if you want to learn more about the latest regulations, technical challenges and solutions related to the blood glucose meter, you are welcome to contact us through wechat to start a win-win cooperation journey together. Look forward to being relevant to you and building a healthy future together!
鸿盟医学
医疗器械全球注册咨询、医疗器械临床试验、医疗器械质量管理体系（ISO13485/GMP/QSR）、医疗器械可用性研究、
医疗器械法规培训为一体的专业技术咨询服务机构
微信号：hom_medical、18018710006 联系电话：18018716006
