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[Cites 0, Cited by 0] [Section 55] [Entire Act]

Union of India - Subsection

Section 55(2) in The Medical Devices Rules, 2017

(2)Where an injury is caused to the participant in a clinical investigation of any investigational medical device and such injury is attributable to the use of investigational medical device, the sponsor permitted under rule 52 shall provide to that participant, medical management and such compensation in the manner as specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945.