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Cover page or login screen (1) Name of sponsor or sponsor logo. (2) Clinical investig ...

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CLINICAL INVESTIGATION PLAN 1.1 General 1.1.1 Introduction This document specifies th ...

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INVESTIGATOR'S BROCHURE (IB) 1. General 1.1 Introduction Information Brochure shall c ...

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Recall detail Footnotes i Type of Product: Medicine, Medical Device, or Biological ii ...

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For a new in vitro diagnostic medical device: Where relevant to demonstrating conform ...

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Monitoring plan General outline of the monitoring plan to be followed, including acce ...

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(3) If on receipt of the application and the report referred to in sub-rule (2), the ...

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. The applicant shall provide and maintain suitable equipment having regard to the na ...