To be marketed in Australia, medical devices and in vitro diagnostic medical devices (IVDs) must be included in the Australian Register of Therapeutic Goods (ARTG), managed by the Therapeutic Goods Administration (TGA).

Foreign manufacturers intending to place their devices on the Australian market must appoint an Australian Sponsor, namely the local entity responsible for the inclusion of the device in the ARTG and for the regulatory obligations related to its commercialization in Australia.

Registration Procedure

The ARTG inclusion procedure first requires verification of the correct device classification according to the applicable TGA rules.

The Sponsor then collects the required technical documentation and conformity evidence and submits the application to the TGA. During the assessment phase, the authority may request clarifications or additional documentation before proceeding with the inclusion of the device in the register.

For certain device classes, the TGA may also require additional conformity assessment evidence or subject the application to an application audit procedures.

Applicant

Within the Australian system, the Applicant generally coincides with the Australian Sponsor, who submits the ARTG inclusion application on behalf of the manufacturer.

The Sponsor also acts as the main local regulatory contact and manages communications with the TGA as well as regulatory obligations related to the commercialization of the device in Australia.

Timelines and Costs

ARTG inclusion requires payment of an initial application fee and an annual charge to maintain the registration, according to fees periodically updated by the TGA.

Assessment timelines vary depending on the device risk class, the completeness of the submitted documentation, and the possible need for additional information requests or audit activities by the authority.

Validity

ARTG inclusion does not have a predefined expiration date, provided that applicable regulatory obligations are fulfilled, including payment of annual charges and continued compliance with TGA requirements.

Documentation Language and Labelling

Technical documentation and labelling must be available in English.

Information relating to the Australian Sponsor must be made available according to applicable device labelling and identification requirements, including on the device, packaging, or instructions for use, where applicable.

Useful Information

The Australian regulatory system is broadly similar to the European framework in its overall structure; however, compliance must be demonstrated according to specific Australian requirements.

CE documentation may be useful in supporting the dossier, but it should not be considered an automatic substitute for TGA requirements.