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Details of suspected adverse device reaction(s): (a) Full description of reaction(s) inclu...

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Procedural issues A system shall be established to enable cross-referencing of CRFs and CI...

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Digitalisation of form The Forms prescribed under these rules may be suitably modified for...

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Supply of medical device to hospitals against delivery challan Central Drugs Standard Cont...

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Fresh application in case of change in constitution In case of change in constitution of a...

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Overriding effect The provisions of these rules shall have effect, notwithstanding anythin...

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Supply of medical device to hospitals against delivery challan Central Drugs Standard Cont...

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Test licence for import for test, evaluation, clinical investigations, etc. (1) Notwithst...

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

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