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Implantable medical devices and surgically invasive medical devices for long term use (a) ...

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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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DEVICE MASTER FILE FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary An execu...

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Note: 1. All reports submitted as a part of the dossier should be signed and dated by the...

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

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

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7.0 Verification and validation of the medical device 7.1 General: (A) The dossier should ...

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

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