Australia · Therapeutic Goods Administration · Medical devices
Review target
-
Not published
Legal time limit
255 working days
regulation
Steps
4
2 requirements
Application fee
A$64,810
FY2026-27
The agency itself can assess a manufacturer's quality system and, for high risk devices, the device design, and issue a conformity assessment certificate. When the design is examined, the rules set a decision limit of 255 working days, with clock stops for questions. Overseas reports can support an abridged assessment. Manufacturers that choose, or need, a certificate from the Australian regulator, for example when no suitable overseas evidence exists.
The initial assessment, design examination is A$64,810 for FY2026-27.
1. Application for conformity assessment; 2. Assessment and decision (255 days); 3. Answers to queries; 4. Certificate issued.
Outcome: A conformity assessment certificate, used as manufacturer evidence for register inclusion.
Legal basis: Therapeutic Goods Act 1989, Chapter 4 Part 4-4; Therapeutic Goods (Medical Devices) Regulations 2002, regulations 3.6 to 3.9 and 4.3
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 255 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
| Legal time limitregulation. Applies when the design is examined. Time waiting for answers to queries is not counted. | 255 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Initial assessment, design examinationApplication · FY2026-27 | A$64,810 |
| Initial assessment, type examinationApplication · FY2026-27 | A$49,609 |
| Initial assessment, full quality management systemInspection · FY2026-27 | A$36,249 |
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, 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 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
| Initial assessment, production quality management systemInspection · FY2026-27 |
| A$31,717 |
| Conformity assessment application feeApplication · FY2026-27 | A$1,603 |