Australia · Therapeutic Goods Administration · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
2 requirements
Application fee
A$12,591
FY2026-27
A priority applicant determination gives front-of-queue handling for a register inclusion application or a conformity assessment application. It is for devices for serious conditions with unmet need and a major clinical advantage, or IVDs with a major public health benefit. A device for a life-threatening or seriously debilitating condition that is a breakthrough technology or offers a major clinical advantage.
The priority applicant determination for register inclusion (devices and ivds) is A$12,591 for FY2026-27.
1. Apply for a priority applicant determination; 2. Assessment of the determination (20 days); 3. Lodge the inclusion or conformity assessment application; 4. Front-of-queue assessment.
Outcome: Front-of-queue assessment; approval is not guaranteed.
Legal basis: Therapeutic Goods Act 1989, section 41FKA; Therapeutic Goods (Medical Devices) Regulations 2002, regulations 5.4 to 5.4D
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 203 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Priority applicant determination for register inclusion (devices and IVDs)Designation · FY2026-27 | A$12,591 |
| Priority applicant determination for conformity assessmentDesignation · FY2026-27 | A$11,967 |
Other routes in Australia: Inclusion of Class I non-sterile, non-measuring devices and Class 1 IVDs, Register inclusion of medical devices and IVDs using manufacturer evidence, Conformity assessment certificate issued by the agency, How combination products are regulated. See all routes on the Australia page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.