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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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15.However, detailed guidance documents should be prepared providing the requirements and ...

2023-10-28T05:49:46

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BACKGROUND 1. Import or manufacture for sale of drugs are regulated under Drugs and Cosmet...

2023-10-28T05:40:49

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After the NDA is accepted the various section of the application should undergo concurrent...

2023-10-26T11:13:04

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BACKGROUND 1. Import or manufacture for sale of drugs are regulated under Drugs and Cosmet...

2023-10-26T05:38:50

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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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17.0 In use stability: This section should provide information on in use stability studies...

2023-10-05T05:30:16

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16.0 Claimed Shelf life: This section should provide information on stability testing stud...

2023-10-05T05:30:04

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16.0 Claimed Shelf life: This section should provide information on stability testing stud...

2023-10-04T04:43:45

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