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CLINICAL INVESTIGATION REPORT 1. General This table specifies the contents of the clinical...

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

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New studies specifically planned or conducted to examine a safety issue should be describe...

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PRELIMINARY 1. Short title and commencement (1) These rules may be called the Medical Devi...

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Now, therefore, in exercise of the powers conferred by Section 12 and Section 33 of the Dr...

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PRELIMINARY 1. Short title and commencement (1) These rules may be called the Medical Devi...

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Table of contents The table of contents may include the following information:— Central Dr...

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

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INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed consent ...

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