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Medical device inclusion process

Steps in the process

1 October 2020

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Changes to the application process are underway for Class 1 IVD medical devices are underway. The manufacturer's Declaration of Conformity will soon be required at the time of application.

This guidance is intended for sponsors applying for inclusion of a 'kind of medical device', including IVD medical devices, in the Australian Register of Therapeutic Goods (ARTG).

For guidance on exporting medical devices (from Australia) refer to Application for certificate of free sale or export certificate for a medical device web page.


Before you can apply for a Certificate of Free Sale or an Export Certificate you may need to have an ARTG inclusion for your product. Please review the guidance relating to this process on our website at Certificates of free sale and export certificates for medical devices.

Medical devices, including IVD medical devices, are regulated by the Therapeutic Goods Administration (TGA). We regulate medical devices in accordance with:

Any medical device (unless excluded or exempt under the Act) must be included in the ARTG before it can be legally imported into, supplied within or exported from Australia.

Steps in the process

The following web pages:

  • identify the process you will need to follow to include your device in the ARTG,
  • navigate you through the inclusion processes step-by-step,
  • contain hyperlinks to the regulatory and technical guidance, and application forms you will need to complete each step in the process, and
  • identify when the process is complete.

These are the steps in the medical device inclusion process covered in the following web pages and their associated guidance documents:

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