Australia · Therapeutic Goods Administration · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
A$1,244
FY2026-27
The lowest risk devices are included in the register through a declaration process. The manufacturer applies the declaration of conformity procedure. For Class I devices, the sponsor sends the manufacturer's declaration of conformity with the application. Class 1 IVDs not for self-testing or point of care use a self-declaration. Class I devices that are not sterile and have no measuring function, and Class 1 IVDs not intended for self-testing or point-of-care use.
The ivd inclusion application fee (all classes) is A$1,244 for FY2026-27.
1. Manufacturer declaration of conformity; 2. Sponsor application; 3. Preliminary assessment (20 days); 4. Inclusion or audit.
Outcome: Inclusion in the Australian Register of Therapeutic Goods.
Legal basis: Therapeutic Goods Act 1989, Chapter 4; Therapeutic Goods (Medical Devices) Regulations 2002, regulations 3.9 and 3.9A
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 20 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
| Validationofficial guidance. The agency describes this as a statutory timeframe for preliminary assessment. | 20 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| IVD inclusion application fee (all classes)Application · FY2026-27 | A$1,244 |
| Class I device (other), application feeApplication · FY2026-27 | A$651 |
Other routes in Australia: Register inclusion of medical devices and IVDs using manufacturer evidence, Conformity assessment certificate issued by the agency, Priority review pathway for medical devices and IVDs, 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.