In its latest move to better control the safety of medical devices for sale in India, regulators announced in September that a range of devices used in hospitals will be classified into six separate areas for the purpose of assessment and registration.
The classification areas published by Central Drugs Standard Control Organization (CDSCO) separate devices into those for pain management, nephrology and renal care, software systems, personal protective equipment, conduct of operations, and general hospital use. The classifications give every device a risk class rating of A to D and include a description of each device, its use, and its primary characteristics.
The classification system is designed to make it simpler to classify devices according to their risk and intended use. They are dictated by India’s medical device regulatory framework first put in place in 2017.