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(b) conformity with an in-house test method; (c) the evaluation of pre-clinical and clinic...

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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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(f) animal studies that provide direct evidence of safety and performance of the device, e...

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(f) animal studies that provide direct evidence of safety and performance of the device, e...

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

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1.2 Information regarding sterilization of the device (whether it is sterile or non-steril...

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

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(1) "clinical investigation" means the systematic study of an investigation medical device...

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(1) "clinical investigation" means the systematic study of an investigational medical devi...

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