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

2023-10-05T05:43:24

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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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Proposed instructions for use or electronic instructions for use and labels.] (b) Data to ...

2023-10-05T05:45:10

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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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22.0 Information required to be submitted for the in vitro diagnostic medical device: (1) ...

2023-10-05T05:34:31

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19.0 Clinical Evidence: The device master file should contain the Clinical Evidence, Evalu...

2023-10-05T05:32:49

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18.0 Shipping stability: This section should provide information on shipping stability stu...

2023-10-05T05:31:56

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7.5.4 Customer property: The manufacturer shall exercise care with customer property while...

2023-10-17T06:58:09

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