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Medical devices, including in vitro diagnostic (IVD) medical devices and other therapeutic goods (OTGs), must generally be included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally exported from Australia, unless an exemption or exclusion applies.
For detailed regulatory guidance on exporting medical devices, refer to the Australian Regulatory Guidelines for Medical Devices (ARGMD).
Export certification
Some overseas regulators require evidence that a medical device can be legally supplied in Australia before it can be imported into their country.
To support export activities, the TGA may issue export certification for medical devices included in the ARTG under section 58 of the Therapeutic Goods Act 1989.
Depending on the requirements of the importing country, the TGA may issue:
- A Certificate of Free Sale
- An Export Certificate
Before applying, you should confirm which certificate is required by the importing country's regulator or authority.