Medical devices, including IVD medical devices, are regulated by the Therapeutic Goods Administration (TGA). The TGA regulates medical devices in accordance with the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), and the Therapeutic Goods Regulations 1990. 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. Please note that 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. This guidance is intended for sponsors applying for the inclusion of a 'kind of medical device', including IVD medical devices, in the ARTG.

Here are the steps in the medical device inclusion process covered in the following external link and their associated guidance documents:

• Step 1 - Is your product a medical device that requires inclusion in the ARTG?
• Step 2 - Things to consider prior to application
  • Kind of medical device, including IVD medical device
  • Manufacturer evidence for a medical device or IVD medical device
  • Classification of the medical device or IVD medical device
  • Priority review designation
  • Supporting documentation for inclusion of a medical device or IVD medical device, in the ARTG
  • Auditing of applications for ARTG inclusion of a medical device or IVD medical device in the ARTG

• Step 3 - Accessing TGA Business Services system (TBS)
• Step 4 - Submitting an application in TBS for Class I non-sterile, non-measuring and Class 1 IVD medical devices
• Step 5 - Submitting an application in TBS for Class I Medical Device (Export Only) and Class 1 IVD medical device (Export Only)
• Step 6 - Submitting an application in TBS (for all classes except Class I non-sterile, non-measuring medical device, Class 1 IVD medical device and Class I medical device/Class 1 IVD medical device Export Only)
• Step 7 - Processing your application
• Step 8 - Printing your ARTG certificate of inclusion
• Ongoing responsibilities