Medical Device Registration Consultant

  VOLUNTARY REGISTRATION OF MEDICAL DEVICES IN INDIA At present, India is at the stage of growing and expanding its domain in the industry of Medi ca l Devices in the country. Due to the limited regulated medical devices in the c ountry, India is at a challenging stage of establishing itself in the medical devices sector in the country. In past, India has faced a shortage of regulated medical devices in comparison to all the leading countries in the world, and hence, to overcome such situations in recent times India ha s focused and laid more emphasis on establishing, reforming, and implementing medical device rules and regulations in the country. In India, the Central Drugs Standard Control Organization is the regulating body for medical devices in the country.   ELT Corporate is one of the leading medical device registration   consultants in India at present who aims at delivering the best services to each and every person in I ndia in the field of medical device s .

  Medical Devices are the most found and used devices in day-to-day basis. Medical Device Rules, 2017 states the rules and regulations applied to medical devices in India. With a limited number of medical devices notified by the central government in India most of the medical device's requirement are met with the help of other foreign countries. The rules for Medical Device Registration in India are applicable on in –vitro diagnosis, surgical dressings, surgical procedures, insecticides , mechanical contraceptives, disinfectants and such devices notified under the Drugs and Cosmetics Act, 1940. ELT Corporate and its team helps our clients in all the issues and problems they face related to voluntary registration of medical dev ices in India .   Some medical devices in India are not yet approved by the Central Drugs Standard Control Organization ( herein after referred as ‘ CDSCO ’ ) . For implementation of such non-regulated medical devices, CDSCO has established a scheme