(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.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:Provided that no fee shall be payable by any institute, organization, hospital run or funded by the Central Government or the State Government, as the case may be, for conduct of clinical investigation.
