51. 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.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.(3)No permission for conduct of academic clinical study on licenced medical device shall be required, where,-(a)the Ethics Committee approves such a study; and(b)the data generated during the study shall not be used to furnish to the Central Licensing Authority to manufacture or to import for marketing any investigational medical device in the country.(4)The Central Licensing Authority may, in public interest, abbreviate, defer, or waive the requirement of animal data or clinical data for conducting clinical investigation for reasons to be recorded in writing before granting permission to conduct clinical investigation.(5)Medical devices requiring clinical investigation but claiming substantial equivalence to a predicate device shall not be marketed unless the Central Licensing Authority has approved it.Explanation 1. - For the purposes of this sub-rule, a device shall be deemed to be substantially equivalent in comparison to a predicate device, if it has. -(i)the same intended use and technological characteristics; or(ii)same intended use and different technological characteristics, and demonstrate that the device is as safe and effective as the predicate device.Explanation 2. - A claim of substantial equivalence does not mean that the proposed medical device and predicate device are identical. Substantial equivalence shall be established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, bio-compatibility, standards, and other characteristics, as applicable.
