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7.4 Biological safety: (i) The dossier should contain a list of all materials of animal or...

2023-09-16T04:47:13

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7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in direct or...

2023-09-16T04:43:15

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Note: Configuration management is a means by which identification and traceability can be...

2023-10-17T05:40:48

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7.5.1.1 General requirements The manufacturer shall plan and carry out production and serv...

2023-10-17T05:26:07

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3.6 Component means any raw material, substance, piece, part, software, firmware, labeling...

2023-10-09T05:41:06

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

2023-10-05T05:34:31

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(b) the intended user (lay person or professional); (c) a general description of the princ...

2023-09-16T05:31:26

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

2023-09-16T04:41:25

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