What exporters to Australia need to know about TGA: who needs it, products covered, the step-by-step process, documents and timelines.
| Authority | Therapeutic Goods Administration (TGA) |
|---|---|
| Countries | Australia |
| Mark | AUST R / AUST L number |
| Requirement | Mandatory |
| Typical timeline | Varies – ask us |
| Validity | Ongoing, subject to annual charges |
| Local representative | Yes – Australian sponsor |
The Therapeutic Goods Administration (TGA) regulates medicines and medical devices in Australia. Products must be included in the Australian Register of Therapeutic Goods (ARTG) by an Australian sponsor before supply. For medical devices, approvals from comparable overseas regulators – such as CE certification under the EU MDR – are often used as evidence.
Examples only – coverage is set by the regulator’s current product list and HS codes. We confirm it for your product free of charge.
Yes – Therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) by an Australian sponsor before supply; medical devices often use CE / EU MDR or other comparable overseas approvals as evidence.
Typical products include Medicines & APIs, Medical devices, In-vitro diagnostics, Surgical consumables and Complementary medicines. The official list changes over time, so we confirm coverage for your exact product and HS code in a free applicability check.
Yes – Australian sponsor. PCN coordinates with your importer or arranges a representative where needed.
Typical timeline: Varies – ask us. Validity: Ongoing, subject to annual charges. Share your product details and we will give you a realistic plan and cost.
No. The sponsor must be an Australian resident or company; we can connect you with sponsor services or work with your Australian distributor.
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