Lords Mark Industries Ltd.-Renalyx Wins Licence to Manufacture Class C World's First AI-Based Smart HemoDialysis Machines

Lords Mark Industries Ltd. (LMIL) has achieved a defining milestone in India's med-tech landscape by receiving the licence to manufacture Class C World's First AI-Based Smart Hemodialysis Machines from the Central Drugs Standard Control Organisation (CDSCO), a critical step that significantly strengthens the country's self-reliance in lifesaving healthcare technology.

- TBG NETWORK

This achievement becomes even more historic as LMIL-Renalyx has now received the globally recognised CE marking, making it one of only sixth brand 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). 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 under the high-risk, life-sustaining category, which means even a minor engineering or process deviation can directly impact patient survival. To obtain this licence, companies must demonstrate full compliance across nearly 140+ quality, safety, and risk-management parameters, including biocompatibility proof, electromechanical safety validation, sterility assurance, traceability of every component, rigorous docu