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7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstrates ...

2023-09-16T04:55:48

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7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide e...

2023-09-16T04:53:32

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7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide e...

2023-09-16T04:51:42

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As a company, we have one of the largest number of briefs on Diagnostics & Medical Devices...

2023-12-12T05:04:09

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

2023-10-05T05:40:02

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(3) In case of imported diagnostic in vitro diagnostic medical devices, the report of eval...

2023-10-05T05:38:09

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21.0 Post marketing surveillance data (vigilance reporting): The dossier should contain th...

2023-10-05T05:33:42

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1.1 Introductory descriptive information on the in vitro diagnostic medical device, the in...

2023-09-16T05:04:26

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

2023-09-16T04:57:03

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