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Lords Mark Industries Ltd.–Renalyx Wins Licence for Class C AI-Based Hemodialysis Machines, Earns CE Certification
Lords Mark Industries Ltd. receives license to manufacture AI-Based Smart Hemodialysis Machines, boosting India's healthcare self-reliance.
Lords Mark Industries Ltd. (LMIL) has achieved a milestone in India's med-tech landscape by receiving the licence to manufacture Class C AI-Based Smart Hemodialysis Machines from the Central Drugs Standard Control Organisation (CDSCO), a step that may strengthen the country’s self-reliance in healthcare technology.
LMIL–Renalyx has received the globally recognised CE marking, making it one of six brands worldwide to earn this certification for dialysis systems. The CE marking showcases that the product meets the European Union’s =health, safety, and environmental protection standards, enabling legal access to the European Economic Area (EEA).
Securing a licence to manufacture Class C AI-Based Smart Hemodialysis Machines is one of the more challenging regulatory achievements in India’s med-tech regime. Class C devices fall under the high-risk, life-sustaining category, which means even a minor engineering or process deviation can directly impact patient safety. To obtain this licence, companies must demonstrate compliance across nearly 140+ quality, safety, and risk-management parameters, including biocompatibility proof, electromechanical safety validation, sterility assurance, traceability of every component, documentation, and multi-stage plant audits. Few manufacturers attempt this category because the bar for approval is comparable to global regulatory standards. This certification is therefore significant: it is the formal authorisation that allows LMIL to build renal-care equipment domestically, help reduce dependence on imported machines, and ensure that India’s dialysis infrastructure is supported by globally benchmarked, compliant technologies.
This achievement has come at an important 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. India operates fewer than 6,000 dialysis centres, and demand for treatment is growing at 10–12% CAGR, while the nation remains dependent on imported equipment.
At the heart of this development is LMIL’s innovation ecosystem, which powers the AI-Based Smart Hemodialysis Machines —developed jointly with Renalyx. This platform integrates AI-driven automation, predictive safety alerts, treatment optimisation, and real-time analytics to reduce human error and support clinical precision. The licence marks a milestone in bringing this technology to market at scale.
Strengthening its innovation pipeline, LMIL–Renalyx has expanded a R&D ecosystem focused on kidney-care technologies, liver-care engineering, sensing systems, and data-driven renal informatics.
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. Our mission is to create intelligent, safe, and accessible healthcare technologies from India that can serve the world.”
By becoming the company to manufacture an AI-Powered Smart Hemodialysis Machine, and by securing both the Indian manufacturing licence and global CE marking, LMIL–Renalyx has laid the foundation for growth in Indian medical technology.
For more details visit :- https://lordsmark.com/
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