Priority review designations medical devices (including IVDs)

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Version 1.1, February 2018

13 February 2018


This guidance is intended to assist applicants seeking designation for Priority Review of either TGA conformity assessment, or inclusion in the Australian Register of Therapeutic Goods (ARTG) of a medical device.

Applications which are granted a Priority Review designation will be allocated 'front-of-queue' priority throughout the relevant assessment process. This includes TGA business processes associated with applications for conformity assessment, and inclusion on the ARTG for medical devices.

Designation decisions lapse after six (6) months, unless we receive an application for either TGA conformity assessment or ARTG inclusion during this time. Information about TGA conformity assessment and ARTG inclusion applications can be found at Standards, guidelines & publications (medical devices & IVDs).

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