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2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationale fo...

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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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(iv) ISO-10993, Biological Evaluation of Medical Devices, should be followed for conductin...

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

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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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Medical devices requiring clinical investigation but claiming substantial equivalence to ...

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"notified" means notified in the Official Gazette by the Central Government, (zj) "Notif...

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