Currently, the Indian medical device and pharmaceutical market is largely unregulated and medical devices can be freely imported into the country. The Ministry of Health and Family Welfare and the Central Drugs Standard Control Organization (CDSCO) are the two regulatory bodies that are responsible for overseeing medical devices within India. The CDSCO exercises regulatory control over the import of medical devices and approves new medical devices and clinical trials. The CDSCO also oversees the Central Licensing Approving Authority (CLAA), the body responsible for ensuring medical device compliance. Under India medical device regulations, only certain medical devices require pre-market review, while other products that are typically regarded as devices are instead classified as drugs.