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Recall Action Commencement Date: The date the recall strategy and communication was agreed...

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

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

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Obtaining a regulatory license often involves an application process, fees, background che...

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

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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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the licence holder shall, on being informed by the Central Licensing Authority or State Li...

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

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