You are here
Medical device inclusion process
Steps in the process
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.
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:
- The Therapeutic Goods Act 1989 (the Act)
- The Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)
- 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.
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:
- 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 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