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POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be des...

2023-10-28T05:47:16

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The manufacturer shall maintain records of the process parameters for the sterilization pr...

2023-10-17T05:35:51

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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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POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be des...

2023-10-26T11:09:31

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POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be des...

2023-10-25T05:12:05

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The manufacturer shall establish and maintain a record for each batch of medical device or...

2023-10-17T05:27:04

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Design and development validation: Design and development validation shall be performed in...

2023-11-04T06:10:50

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7.3.6 Design and development validation: Design and development validation shall be perfor...

2023-10-13T05:21:41

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