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Reduction of assessment fees for medical devices
Version 3.0, November 2015
|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|
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|
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|