Lords Mark Industries Ltd.–Renalyx Wins Licence to Produce Class C Worlds First AI Based Smart HemoDialysis Machines, Becomes 6 th CE Certified Brand in the World

This is a major step which has helped Lords Mark Industries Ltd. (LMIL) gain a defining milestone in the med-tech industry of India receiving licence to produce Class C World’s First AI-Based Smart Hemodialysis Machines by the Central Drugs Standard Control Organisation, (CDSCO) and this move has greatly bolstered the autonomy of the nation in producing the life-saving technology of healthcare.

This is even more history because now LMIL-Renalyx is a recipient of the globally recognised CE marking, therefore, becoming one of six brands globally to have received this certification as dialysis systems. The CE mark certificate confirms that the product underwent the top health, safety and environmental safety standards in the European Union to be able to be legally used in the whole European Economic Area (EEA).

The licence of manufacturing the World First AI-Based Smart Hemodialysis Machines in Class C is among the hardest regulatory milestones in the med-tech regime in India. The category C devices are classified as high-risk, life-sustaining devices, implying that any slight engineering or process failure can have a direct effect on patient survival. In order to acquire this licence, firms are obliged to provide complete conformity to almost 140+ quality, safety and risk-management criteria, such as biocompatibility demonstration, electromechanical safety testing, sterility certification, traceability of all components, intensive documentation and multi-tier plant audit. Not many manufacturers venture into this category since approval is made up of similar conditions as those of world regulations. This certification is thus essential: it is the official licence that will enable LMIL to manufacture high-technology renal-care equipment within the country, decrease national reliance on imported equipment, and make sure that the dialysis infrastructure India will be relying on will be supported by technologies of international quality and full compliance, as well as save human lives.

This has been obtained at the right time in India. The USD 5 billion dialysis market of the country has 1820 lakh CKD patients which have 2.22.5 lakh new ESRD cases coming annually. However, in India, there are less than 6,000 dialysis centres, and the treatment demand is 10-12% CAGR, and the country is extremely reliant on the equipment supplied by foreign countries.