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e) a description of the accessories, other medical device and other product that are not m...

2023-09-14T04:56:32

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

2023-10-05T05:34:31

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14.0 Definition of Assay Cut-off: This section should provide a summary of analytical data...

2023-10-04T04:42:51

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(ii) the applicant shall provide adequate space having regard to the nature and number of ...

2023-08-28T05:20:45

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(ii) the applicant shall provide adequate space having regard to the nature and number of ...

2023-08-10T05:42:46

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DESIGN ANALYSIS DATA Design Analysis Data for a medical device shall include the following...

2023-07-10T08:57:56

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Customer complaint—Written, electronic or oral communication that alleges deficiencies rel...

2023-06-28T10:39:13

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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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