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[Cites 0, Cited by 0] [Section 63(1)] [Section 63] [Entire Act]

Union of India - Subsection

Section 63(1)(b) in The Medical Devices Rules, 2017

(b)the applicant has given an undertaking in writing to conduct post marketing clinical investigation with the objective of safety and performance of such investigational medical device as per protocol approved by the Central Licensing Authority.