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

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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

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1.8 Domestic price of the device in the currency followed in the country of origin. 1.9 L...

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

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

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

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

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DEVICE MASTER FILE FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary An execu...

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