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Lords Mark Industries Ltd: Renalyx Secures Licence for Class C AI-Enabled Hemodialysis Machines and Achieves CE Certification
Lords Mark Industries Ltd: Renalyx Secures Licence for Class C AI-Enabled Hemodialysis Machines and Achieves CE Certification
Regulatory milestone: Lords Mark Industries Ltd. (LMIL), through its Renalyx division, has received a manufacturing licence from the Central Drugs Standard Control Organisation (CDSCO) to produce Class C AI‑based smart haemodialysis machines. Class C devices are high‑risk, life‑sustaining medical equipment requiring stringent safety, quality and risk‑management standards.
Global certification: LMIL–Renalyx has also earned the CE marking, a globally recognised certification showing compliance with the European Union’s health, safety and environmental protection standards. This makes Renalyx one of only six brands worldwide to receive CE certification for dialysis systems, allowing legal access to the European Economic Area (EEA).
Innovation leadership: The approved machines integrate AI‑driven automation, predictive safety alerts, treatment optimisation and real‑time analytics, designed to enhance clinical precision and reduce human error in dialysis therapy.
Strategic healthcare impact: This regulatory achievement strengthens India’s self‑reliance in critical healthcare technology, enabling domestic production of advanced dialysis equipment, which has historically been import‑dependent.
Market context: India’s dialysis market was valued at around USD 5 billion in 2024, serving an estimated 18–20 lakh chronic kidney disease (CKD) patients, with 2.2–2.5 lakh new end‑stage renal disease cases each year. Demand for dialysis services is growing at around 10–12% CAGR, while the number of dialysis centres remains limited.
Domestic advantage: Securing the licence for Class C AI‑based machines — one of the most stringent regulatory approvals in India’s med‑tech framework — positions LMIL as a leader in the renal care segment and helps reduce dependence on imported life‑saving medical devices.
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