The Central Drug Standards Control Organization (CDSCO) is India's main regulatory body for pharmaceuticals and medical devices. ... In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India's Drugs & Cosmetic Act and Rules (DCA). The Bill had been drafted in 2006 by the then UPA government. Following that, under the current NDA government, a Group of Ministers (GoM) was constituted under the Union Finance Minister Arun Jaitley. However, the GoM had postponed the legislation, and had introduced the Medical Device Rules and Regulations. The new set of rules was released in 2017, and notified on January 1, 2018. The Indian medical regulatory system has become more complicated in recent years. In the past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered. With the rising opportunities in India comes increasing regulations that companies must face and overcome. With the assistance of a highly experienced third-party regulatory compliance consultant such as Pacific Bridge Medical, the registration process is much less complex. We can help you prepare and submit the required documents and materials to the relevant regulatory agencies in India.