Priority review pathway for medical devices

TGA priority review pathway gives eligible medical devices faster, front‑of‑queue assessment to accelerate access for products addressing serious conditions and unmet clinical needs

Last updated

9 May 2023

You may qualify for priority review designation if your device:

is intended for the monitoring, treatment, prevention or diagnosis of a life threatening or seriously debilitating condition;
there is currently an unmet need for your device; and your device represents breakthrough technology or provides a clinical advantage (or public health need for IVD medical devices),

Priority review means your application has 'front-of-queue' priority status.

Understanding priority applicant determination rules for medical devices including in-vitro diagnostics (IVDs)

27 September 2024

Guidance

Guidance on the priority applicant determination criteria and process for medical devices including in vitro diagnostics (IVDs).
Application for medical device priority applicant determination

2 August 2022

Forms

Information and links to the medical devices priority applicant determination application form.
Medical devices (including IVDs) priority applicant determination notices

11 May 2026

Page

Medical devices priority applicant determination notices and eligibility for priority review pathway.

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Priority review pathway for medical devices

Understanding priority applicant determination rules for medical devices including in-vitro diagnostics (IVDs)

Application for medical device priority applicant determination

Medical devices (including IVDs) priority applicant determination notices

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Priority review pathway for medical devices