The regulatory framework for medical devices in India is based on drug regulations under the Drugs and Cosmetics Act of 1940 and Drugs and Cosmetics Rules of 1945. The Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO) regulates medical devices and IVDs. Currently only a limited number of medical device and IVD products require registration in India, including ablation devices, dental implants, and hernia mesh. The registration process for notified devices can take 9-12 months and involves appointing an authorized agent, compiling an application, and obtaining CDSCO approval.