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 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.
Find out what's needed to include a medical device in the ARTG by clicking the links below.
Check your product needs inclusion
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PageCheck 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
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PageMedical devices, including IVD medical devices, are included in the Australian Register of Therapeutic Goods (ARTG) as a 'kind of medical device'.
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PageHow medical devices are classified, including in vitro diagnostics (IVDs).
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PageMedical device priority review information and application form.
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PageWhat you need to submit to include medical devices in the ARTG, including IVDs.
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PageFind 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.
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SectionSet up your TGA Business Services account and manage applications and ARTG entries.
Submitting an application
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PageInformation about the application process and forms.
Processing your application
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PagePossible outcomes of your application and what happens next.
Printing your certificate of inclusion
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PageThe Australian Register of Therapeutic Goods (ARTG) certificate printing instructions.
Ongoing responsibilities
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.