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Investigational medical device and methods 6.1 Investigational medical device description ...

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CLINICAL INVESTIGATION PLAN 1.1 General 1.1.1 Introduction This document specifies the con...

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Where product requirements are changed, the manufacturer shall ensure that relevant docume...

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Central medical device testing laboratory (1) The Central Government may, by notification,...

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Abbreviated terms and definitions A list of abbreviated terms and definitions of specializ...

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Ethics Committee This section shall document that the clinical investigation was conducted...

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UNDERTAKING BY THE INVESTIGATOR 1. Full name, address and title of the Principal Investig...

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Data management (a) Procedures used for data review, database cleaning, and issuing and re...

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Regulatory and other references (a) List of International Standards, if any, complied with...

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