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Priority review designations medical devices (including IVDs)

Version 1.2, August 2018

23 August 2018

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The purpose of this guidance is to help manufacturers and sponsors understand how the TGA interprets regulations, and thus indicate how to comply.

This is a guide only, and manufacturers and sponsors are encouraged to familiarise themselves with the legislative and regulatory requirements in Australia. If necessary, seek professional advice as it is the responsibility of each manufacturer or sponsor to understand and comply with these requirements.

This document will evolve over time and updates and clarifications will be included as required. Feedback on the guidance is always welcome.

Introduction

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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