(2)An application for grant of permission to conduct, clinical performance evaluation of new in vitro diagnostic medical device shall be made to the Central Licensing Authority in Form MD-24 by the sponsor and shall be accompanied with a fee as specified in the Second Schedule along with information specified in sub-rule (3) duly signed by the sponsor in India:Provided that no fee shall be required to be paid by the institutes, organization, hospitals, run by the Central Government or the State Government, involved in conduct of clinical performance evaluation of new in vitro diagnostic medical devices.
