If you intend to supply a medical device in Australia, you need to meet the definition of a Sponsor under the Therapeutic Goods Act 1989. These requirements include that you must be a recognised Australian-based legal entity.
Before you apply to include a medical device in the ARTG, you need to establish a relationship with the medical device manufacturer in order to:
- obtain documentation/information required to demonstrate that the kind of medical device complies with the regulatory requirements in Australia
- provide documentation/information relating to the regulatory, technical, clinical and safety aspects of the device that we may request at any time while you are supplying the device in Australia
- advise you of any problems, safety alerts or recalls that may arise with the use of the device.
Please click on the links below, to find out what is needed to include a medical device in the ARTG.
Check your product needs inclusion
- Confirm your product is a medical device that needs to be included in the ARTGPageCheck if your product is a medical device and if it needs to be included in the Australian Register of Therapeutic Goods (ARTG).
Things to consider before you apply
- What 'kind of medical device' is itPageMedical devices, including IVD medical devices, are included in the Australian Register of Therapeutic Goods (ARTG) as a 'kind of medical device'.
- Classification of medical devicesPageInformation on the classification of medical devices, including in vitro diagnostics (IVDs).
- Priority review pathway for medical devicesPageLinks to information on, and application form for, the priority review pathway for medical devices.
- Documents to support your medical device inclusionPageWhat documents you need to support the inclusion of a medical device, including IVDs, in the Australian Register of Therapeutic Goods (ARTG).
- Prepare for a medical device application auditPageFind out when an application audit may be conducted and understand the audit assessment process.
Accessing TGA Business Services
You will need to have a Client ID and access to the TGA Business Services (TBS) website in order to submit your medical device application. Follow the link below for information about setting up and maintaining your TGA account.
- TGA Business Services (TBS)SectionSet up your TGA Business Services account and manage applications and ARTG entries.
Submitting an application
- Submit your application for inclusion of a medical devicePageInformation about the application process and forms.
Processing your application
- Processing your application for inclusion of a medical devicePagePossible outcomes of your application and what happens next.
Printing your certificate of inclusion
- Print the ARTG certificate of inclusion for your medical devicePageInstructions for printing your certificate of inclusion in the Australian Register of Therapeutic Goods (ARTG).