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7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in direct or...

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In vitro diagnostic medical devices for blood grouping or tissue typing (a) Subject to cl...

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(b) If the in vitro diagnostic medical device contains any of the following then descripti...

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(b) If the device contains any of the followings, then descriptive information on the fol...

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Best Regulatory Affair in Delhi NCR. iv Recall Action Level: The level to which the recall...

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7.4 Biological safety: (i) The dossier should contain a list of all materials of animal or...

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(B) Such summary information may include: (i) declaration or certificate of conformity to ...

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Permission to conduct clinical performance evaluation for new in vitro diagnostic medical...

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

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