Lords Mark Industries Ltd. (LMIL) has reached an important milestone in India’s med-tech space by receiving a licence from the Central Drugs Standard Control Organisation (CDSCO) to manufacture Class C AI-based smart haemodialysis machines. This marks a step forward in strengthening the country’s self-reliance in essential healthcare technology..

Lords Mark Industries Ltd.（LMIL）在印度医疗技术领域取得了重要里程碑，获得了中央药品标准控制组织（CDSCO）颁发的生产C类基于人工智能的智能血液透析机的许可证。这标志着该国在关键医疗技术领域的自力更生迈出了重要的一步。

This achievement is further strengthened by LMIL–Renalyx receiving the globally recognised CE marking, making it one of only six brands worldwide to earn this certification for dialysis systems.The CE marking validates that the product meets the European Union’s highest health, safety, and environmental protection standards, enabling legal access to the entire European Economic Area (EEA)..

这一成就因LMIL-Renalyx获得全球认可的CE标志而进一步增强，使其成为全球仅有的六个获得透析系统认证的品牌之一。CE标志确认该产品符合欧盟最高的健康、安全和环境保护标准，从而合法进入整个欧洲经济区（EEA）。

Securing a licence to manufacture Class C world’s first AI-based smart hemodialysis machines is one of the toughest regulatory achievements in India’s med-tech regime. Class C devices fall into the high-risk, life-sustaining category, meaning even a minor engineering or process deviation can directly affect patient survival.

获得制造C类世界级首台基于人工智能的智能血液透析机的许可，是印度医疗技术监管体制中最艰难的成就之一。C类设备属于高风险、维持生命的类别，这意味着即使是一个小小的工程或流程偏差，也可能直接影响患者的生存。

To obtain this licence, companies must demonstrate full compliance across approximately over 140 quality, safety, and risk-management parameters, including biocompatibility proof, electromechanical safety validation, sterility assurance, traceability of every component, rigorous documentation, and multi-stage plant audits.

要获得该许可证，公司必须在大约140多项质量、安全和风险管理参数上展示全面合规性，包括生物相容性证明、机电安全验证、无菌保证、每个组件的可追溯性、严格的文件记录以及多阶段的工厂审核。

Very few manufacturers attempt this category because the bar for approval is comparable to global regulatory standards. This certification is therefore critical: it is the formal authorisation that allows LMIL to build advanced renal-care equipment domestically, reduce national dependence on imported machines, and ensure that India’s dialysis infrastructure is supported by globally benchmarked, fully compliant, life-saving technologies..

很少有制造商尝试这一类别，因为获得批准的门槛可比全球监管标准。因此，该认证至关重要：它是允许LMIL在国内建造先进的肾病护理设备、减少国家对进口机器的依赖，并确保印度的透析基础设施得到全球基准、完全合规、挽救生命的技术支持的正式授权。

This achievement has come at a pivotal moment for India. The country’s dialysis market, valued at USD 5 billion in 2024, serves an estimated 18–20 lakh CKD patients, with 2.2–2.5 lakh new ESRD cases emerging annually. Yet India operates fewer than 6,000 dialysis centres, and demand for treatment is growing at a 10–12% compound annual growth rate (CAGR), while the nation remains heavily dependent on imported equipment..

这一成就的取得对印度来说正值一个关键时期。2024年，印度的透析市场价值达到50亿美元，服务于大约180万至200万慢性肾病（CKD）患者，每年新增22万至25万终末期肾病（ESRD）病例。然而，印度目前运营的透析中心不足6000家，而治疗需求正以10%-12%的年复合增长率（CAGR）持续增长，同时国家仍然严重依赖进口设备。

At the heart of this breakthrough is LMIL’s innovation ecosystem, which powers the

这一突破的核心是LMIL的创新生态系统，它推动了

world’s first AI-based smart hemodialysis machines

世界上首台基于人工智能的智能血液透析机

, developed jointly with Renalyx. This next-generation platform integrates AI-driven automation, predictive safety alerts, treatment optimisation, and real-time analytics to reduce human error and elevate clinical precision. The licence marks a major milestone in bringing this technology to market at scale..

，与Renalyx联合开发。这个下一代平台集成了人工智能驱动的自动化、预测性安全警报、治疗优化和实时分析，以减少人为错误并提高临床精确度。该许可标志着将这项技术大规模推向市场的一个重要里程碑。

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Strengthening its innovation pipeline, LMIL–Renalyx has expanded a specialised R&D ecosystem focused on future kidney-care technologies, liver-care engineering, advanced sensing systems, and data-driven renal informatics.

加强其创新渠道，LMIL-Renalyx扩展了一个专注于未来肾脏护理技术、肝脏护理工程、先进传感系统和数据驱动的肾信息学的专业研发生态系统。

Commenting on this milestone, Sachidanand Upadhyay, Managing Director, Lords Mark Industries Ltd., said: “This licence is not just a regulatory approval, it’s a recognition of India’s ability to build and lead in the world’s most advanced med-tech categories. With our AI-driven smart Hemodialysis Machine and continuous R&D team efforts, we aim to redefine renal care globally.

洛兹马克工业有限公司董事总经理萨奇丹南德·乌帕迪亚在评论这一里程碑时表示：“该许可不仅是监管上的批准，更是对印度在世界上最先进的医疗技术领域中建设和领导能力的认可。凭借我们的人工智能驱动的智能血液透析机和持续不断努力的研发团队，我们的目标是重新定义全球肾脏护理。”

Our mission is to create intelligent, safe, and accessible healthcare technologies from India that can serve the world.”.

我们的使命是从印度创造智能、安全且易于获取的医疗技术，为世界服务。

By becoming the first Indian company to manufacture an AI-powered smart haemodialysis machine, and by securing both the Indian manufacturing licence and the global CE marking, LMIL–Renalyx has taken an important step forward for Indian medical technology, demonstrating progress in innovation, quality and global readiness..

通过成为印度首家制造人工智能驱动的智能血液透析机的公司，并获得印度制造许可证和全球CE标志，LMIL-Renalyx在印度医疗技术领域迈出了重要的一步，展示了其在创新、质量和全球准备度方面的进步。

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免责声明：上述内容为非编辑内容，TIL在此声明，对其不承担任何明示或暗示的保证，并且不保证、担保或必然认可其中的任何内容。

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