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Medical licenses are regulatory licenses issued to individuals, such as doctors, nurses, p...

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4.0 Design and manufacturing information: 4.1 Device Design: The dossier should contain in...

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(i) for medical devices intended to emit ionizing radiation, information on radiation sour...

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

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

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Manufacturing processes: Central Drugs Standard Control Organization, Ministry of Health a...

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Design and manufacturing information: 4.1 Device Design: The dossier should contain inform...

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

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A PSUR should be structured as follows:— (a) Title Page: The title page of PSUR shall capt...

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