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Description and specification, including variants and accessories of the in vitro diagnost...

2023-06-27T05:11:45

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The device master file should include the following device descriptive information:— (a) i...

2023-05-20T06:48:45

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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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7.0 Analytical Studies: The statements and descriptions in the following sections refer to...

2023-10-03T05:22:57

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Analytical Studies: The statements and descriptions in the following sections refer to all...

2023-06-28T06:37:59

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

2023-06-28T06:52:01

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(b) If the in vitro diagnostic medical device contains any of the following then descripti...

2023-09-16T05:06:09

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Note: 1. All reports submitted as a part of the dossier should be signed and dated by the...

2023-05-20T06:22:46

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