Australia #3353 (v.3)

Therapeutic Goods manufactured for export only

Section 26, 32DCA or Section 26A of the Therapeutic Goods Act 1989
(Note: There is no express provision in the Act for medical devices that are for export only.)

Export-only medicines are required to be listed, rather thanregistered, on the Australian Register of Therapeutic Goods (ARTG) before export. Export-only biologicals and medical devices that are for export onl are required to be included in the ARTG.

Export-only products are assessed against criteria relating to safety and quality, including compliance with applicable standards and manufacturing requirements (noting that medical devices that are for export only would only be subject to pre-market scrutiny if selected for an application audit). Medical devices that are for export only are (as with all medical devices for which an application for marketing approval is made) required to be the subject of a number of certifications when a person applies for inclusion in the ARTG, including that the device complies with the essential principles (these are standards for medical devices). Criminal offences and civil penalties may apply if therapeutic goods are exported from Australia that are not entered in the ARTG, and similarly if such goods are exported and do not comply with applicable standards (or, for medical devices, applicable essential principles). While most of the advertising provisions of the Act do not apply to export only products (this reflects that it is unlikely that such products would be advertised in Australia as their target markets would be overseas), the Secretary may also require information in relation to those products and give directions with respect to export only medicines, export only biologicals or medical devices that are for export only.

HS 2022