ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organizations for the design and development, production, installation, servicing and sales of medical devices. ISO 13485 notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made there under in 1945. Central Drugs Standard Control Organization (CDSCO) assured ISO 13485 certification for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant etc. ISO 13485 - quality management for medical devices certification in India.