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[Cites 0, Cited by 0] [Section 60] [Entire Act]

Union of India - Subsection

Section 60(v) in The Medical Devices Rules, 2017

(v)the laboratories or other institutions taking part in the evaluation study or the sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors, and clinical investigation sites shall be open for inspection by officers of the Central Licensing Authority authorized in this behalf who may be accompanied by officers of State Licensing Authority or outside experts under these rules to verify compliance of the requirements of these rules for conduct of clinical performance evaluation;