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2.0 Device description and product specification, including variants and accessories 2.1 T...

2023-09-14T04:54:40

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2.0 Device description and product specification, including variants and accessories 2.1 T...

2023-09-13T05:26:51

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7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide e...

2023-09-16T04:53:32

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7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide e...

2023-09-16T04:51:42

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Recall detail Footnotes i Type of Product: Medicine, Medical Device, or Biological ii TGA ...

2023-08-25T05:22:17

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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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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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1.2 Information regarding sterilization of the device (whether it is sterile or non-steril...

2023-09-13T05:06:07

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(e) An active diagnostic medical device shall be assigned to Class C, if it is intended fo...

2023-09-02T09:23:45

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