Export-Only Devices
Overview
Medical devices manufactured in Australia and intended for export only — not for supply in the Australian market — may be eligible for ARTG inclusion under an export-only pathway. This allows Australian manufacturers to access the ARTG system for export documentation purposes (Certificates of Free Sale / Export Certificates) without requiring the full conformity assessment pathway required for domestic supply.
The Export-Only ARTG Inclusion
Under Section 41FN of the Therapeutic Goods Act 1989, a device can be included in the ARTG as an export-only device if:
- It is manufactured in Australia
- It is not supplied in Australia (other than for export purposes)
- It meets certain minimum requirements specified in the Act
Export-only ARTG entries are publicly visible but are specifically marked as export-only. They do not authorise supply in Australia.
Certificate of Free Sale / Export Certificate
Australian manufacturers may need a Certificate of Free Sale (CFS) or Export Certificate to accompany shipments to some overseas markets. The TGA issues these certificates for devices included in the ARTG (including export-only entries).
Applications for export certificates are made through the TGA's eBusiness Services portal.
👉 Export certificates for medical devices — TGA
Devices Exported Without ARTG Inclusion
Not all exports require ARTG inclusion. If a manufacturer exports directly to an overseas buyer without needing a Certificate of Free Sale or Export Certificate issued by the TGA, ARTG inclusion may not be necessary. However, the manufacturer remains responsible for ensuring the device complies with the regulatory requirements of the destination country and any international agreements applicable to the export.