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Export of medical devices

To export medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs), you must meet requirements set out in the Australian therapeutic goods legislation.

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Medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs) must be included in the Australian Register of Therapeutic Goods (ARTG) before you can legally export them, unless they are the subject of an exemption or exclusion.

Information regarding the export of medical devices can be found in the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Export certification for medical devices

To facilitate export, the TGA issues export certification for medical devices that are included in the ARTG under section 58 of the Therapeutic Goods Act 1989. If certification is required by the importing country, the TGA can issue a Certificate of Free Sale or Export Certificate.

For more information, refer to Export certification for medical devices guidance.

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