Medical devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. The Indian Medical Devices Regulatory Act (IMRDA) came into force in 2009 to regulate medical devices and establish rules for their classification, standards, conformity assessment, and post-market surveillance. The IMRDA classifies devices into four categories based on risk level and outlines principles like long-term safety and that benefits must outweigh risks. While regulation of medical devices is still developing, recent actions have aimed to strengthen oversight and protect public health.