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3.0 Labelling: The dossier should typically contain a complete set of labeling associated ...

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Recall Action Commencement Date: The date the recall strategy and communication was agreed...

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FIFTH SCHEDULE [Refer rules 20(3), 20(5), 20(8), 22(i)] QUALITY MANAGEMENT SYSTEM FOR MEDI...

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19.0 Clinical Evidence: The device master file should contain the Clinical Evidence, Evalu...

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(ii) Evidence of the ongoing revalidation of the process should also be provided. Typicall...

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4.0 Design and manufacturing information: 4.1 Device Design: The dossier should contain in...

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Important information on the System for Australian Recall Actions The TGA publishes inform...

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(v) "intended use" means the use for which the medical device is intended according to the...

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QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES 1. ...

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