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Requirement of clinical trials on Indian populations The requirement for clinical trials o...

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POLICY ON POST-APPROVAL STUDIES 1. Post-approval studies may be required to provide additi...

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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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(iii) a table compiling all observed device deficiencies that could have led to a serious ...

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Overall synopsis of the clinical investigation A summary or overview of the clinical inves...

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Studies in special populations: The clinical investigation data of the medical device is r...

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

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Overall synopsis of the clinical investigation A summary or overview of the clinical inves...

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