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Reduction of assessment fees for medical devices

Version 3.0, November 2015

30 November 2015

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Version history

Version history
Version Description of change Author Effective date
V1.0 First version of this document. Combined elements of previous internal TGA business rules. Office of Devices Authorisation 06/10/2011
V1.1 Minor amendments for consistency, including clarification that the document does not relate to IVD medical devices. Office of Devices Authorisation 21/11/2011
V2.0

References to Department of Health and Ageing updated to Department of Health

References to Office of Devices Authorisation updated to Devices Authorisation Branch

Various edits to improve clarity including addition of document numbering, addition of information box in Section 3.1.1 and other textual edits.

Correction to Table 1.2 to remove "recertification" and to add "where new certificates are required for previous conformity assessment certificates that are expiring" under Item 1.9.

Fractional fees updated to percentages in Section 3.3

Devices Authorisation Branch 22/04/2015
V3.0

Updated to include IVD medical devices

References to Devices Authorisation Branch updated to Medical Devices Branch

Reference to Monitoring and Compliance Branch in Section 1 removed

Medical Devices Branch 24/11/2015

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