Permission to conduct clinical performance evaluation for new in vitro diagnostic medical device (1) No person or sponsor shall conduct any clinical performance evaluation in respect of a new in vitro diagnostic medical device on any specimen, including blood or tissue derived from human body except under, and in accordance with, the permission granted by the Central Licensing Authority subject to such conditions and in such form and manner as specified in these rules. (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: