Based on your ‘yes’ response to Questions 1, 2 and 3 and ‘no’ to Question 4, this indicates your product is a medical device, and needs to be included in the ARTG.
You may like to check that your medical device is appropriately classified, using the 'What classification is my medical device?’ decision tool.
Including your product in the ARTG
If your product is a medical device, your next step will be to submit an application to include your product in the ARTG. You can do this through the TGA Business Services (TBS).
- You will first need to obtain access to TBS and obtain a client identification number. See Getting started with the TGA for more information.
- You then enter the details of your medical device and fill out the application.
- Once you submit an application and you have received an ARTG number, you may import, export and supply the product. There are fees associated with an application for a medical device as well as ongoing charges to keep your product in the ARTG- these can be found in the schedule of fees and charges.
Remember that it is the responsibility of the sponsor to ensure the product remains compliant with all relevant legislation at all times.
Where to go for more help
The Australian Regulatory Guidelines for Medical Devices (ARGMD) provides information on the regulation of medical devices in Australia.
You may wish to seek the services of a Regulatory Affairs Consultant to assist you with submitting an application.
You can also contact the Medical Device Information Unit (devices@tga.gov.au).