This guide is written from the TGA’s pages on the Personal Importation Scheme and importing and supplying medical devices. The TGA site blocks scripted access, so we read archived 2026 copies; check the live pages. It is not legal advice.
The ARTG
The Australian Register of Therapeutic Goods (ARTG) lists devices that may be supplied in Australia. The TGA says:
- A sponsor must apply to have each kind of medical device included on the ARTG.
- Each ARTG entry is unique to the sponsor, manufacturer and kind of device. A second importer of the same model needs its own entry.
- A condition of inclusion is that the device keeps meeting the TGA’s Essential Principles for safety and performance.
Some Australian retailers print the ARTG number in the listing; Rapid Medical, for example, names ARTG 524233 for the Secure Plus 5 L concentrator. Otherwise, ask the seller, or search the ARTG on the TGA’s site.
Personal Importation Scheme
The scheme lets individuals import therapeutic goods not on the ARTG, usually by post or courier, if the conditions are met:
| Rule | Detail |
|---|---|
| Who uses it | You or an immediate family member: children, parents, grandparents, grandchildren, siblings, spouse or de facto partner |
| Quantity | A three-month supply in any one importation |
| TGA approval | Not required, if the other conditions are met |
| Resale | Not allowed: you cannot sell, supply or give the goods to others |
| Counterfeits | Prohibited in all circumstances |
| Health professionals | May import a device for personal use, but not for use in their practice |
What it means for CPAP and oxygen users
- A machine bought overseas for your own use can come in under the scheme. Repeated or bulk orders are outside “three months’ supply”.
- A personally imported machine cannot be resold in Australia.
- The scheme is separate from GST and from airline rules. See GST-free CPAP and oxygen and flying from Australia.
Penalties
The TGA warns sponsors and health professionals who break the import and supply rules face civil or criminal penalties of up to five years’ imprisonment and/or 5,000 penalty units, with one penalty unit valued at $330 under the Crimes Act 1914.