Application for grant of permission to conduct clinical investigation (1) An application for grant of permission to conduct clinical investigation for investigational medical device shall be made to the Central Licensing Authority in Form MD-22 by a sponsor and shall be accompanied with information specified in the Seventh Schedule. (2) An application for grant of permission to conduct, — (a) a pilot clinical investigation on an investigational medical device as referred to in sub-rule (1) shall be accompanied with a fee as specified in the Second Schedule along with information as specified in the Seventh Schedule. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 48 of 248 Explanation : For the purposes of these rules, the pilot clinical investigation means clinical investigation to be carried out for the first time in human participants; (b) a pivotal clinical investigation on an investigational medical device shall be made on the basis of data emerging from pilot clinical investigation, accompanied with a fee as specified in the Second Schedule: