ARTG
ARTG inclusion explained for overseas manufacturers.
The Australian Register of Therapeutic Goods, or ARTG, is the central register for therapeutic goods that can be lawfully supplied in Australia. For most medical devices and IVDs, inclusion in the ARTG is a key step before commercial supply.
What ARTG inclusion means
ARTG inclusion is not simply a marketing listing. It connects the device, its intended purpose, manufacturer evidence, classification, and Australian sponsor responsibilities. Once a device is included, the sponsor must continue to hold appropriate evidence and respond to post-market obligations.
For overseas manufacturers, the practical question is usually not only whether the product can be included, but what evidence is required, who will act as sponsor, how existing global approvals can be used, and what must be maintained after inclusion.
What manufacturers should prepare
- Clear intended purpose and product variants.
- Device classification rationale for Australia.
- Manufacturer evidence and quality system evidence.
- Technical documentation, clinical or performance evidence, risk management, labelling, and IFU.
- Existing approvals such as EU, FDA, UKCA, Health Canada, or MDSAP evidence.
- A sponsor arrangement and post-market responsibility model.
How Ocevia helps
Ocevia helps overseas manufacturers assess the likely ARTG pathway, identify evidence gaps, prepare application materials, coordinate sponsor responsibilities, and plan for post-market compliance. The aim is to move into Australia with a clear regulatory basis, not a rushed application that later becomes difficult to maintain.