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Medical devices regulation basics
How medical devices are included in the ARTG
The Australian Register of Therapeutic Goods (ARTG) is the central database of therapeutic goods that can be legally supplied in or exported from Australia. Medical devices included in the ARTG have sponsors, who take legal responsibility for their supply in or from Australia.
The sponsors of medical devices are responsible for ensuring they are included in the ARTG, unless exempt or excluded, before supplying them. For more information on what a medical device sponsor needs to do, please refer to the Australian Regulatory Guidelines for Medical Devices (ARGMD).
To do business with the TGA, please establish a TGA eBusiness Services account.
Once a sponsor has all the necessary information for the medical device/s they want to supply, they can lodge an application with the TGA via TGA eBusiness Services.
Useful information for Australian medical device sponsors
- Fees & payments
- Applying for inclusion of a medical device in the ARTG
- Consent for Non-compliant Medical Device(s) - Frequently Asked Questions
- Overview: Regulation of medical devices and in vitro diagnostic (IVD) devices
- Other therapeutic goods that are not medical devices, medicines or biologicals (such as disinfectants and tampons)
Stay informed about medical device regulations
There are several ways to get information about changes to Australia's medical device regulations:
- Subscribe to the fortnightly TGA UPDATE email
- Regularly check the Latest news and updates page
- Keep up with Consultations and reviews page
- Follow the progress of the Medical Devices Reforms page
Regulatory consultants and industry associations
The TGA does not provide the details of consultants who specialise in regulatory affairs and assistance with meeting the therapeutic goods regulations. Sponsors and manufacturers of medical devices may find it helpful to contact a relevant industry association for this kind of information.
- Association of Regulatory and Clinical Scientists Australia Ltd (ARCS)
- Australian Dental Industry Association (ADIA)
- Australian Self-Medication Industry Association (ASMI)
- Complementary Medicines Australia (CMA)
- IVD Australia(link is external)
- Medical Technology Association of Australia (MTAA)
- ACCORD Australasia
Providing feedback to the TGA
Use the following links to:
- Report a suspected breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products.
- Report an advertisement for a suspected breach of the rules.
- Submit an advertising enquiry.
- Report recalls of human blood, and biological products derived from human or live animal materials.
- Report medical device problems, fake therapeutic goods, side-effects of medicines and issues with a medicine's packaging or storage.
- Make an enquiry about or apply to join the Authorised Prescribers Scheme.
- Contact us through our other channels to enquire about issues related to COVID-19 and a wide range of other specific matters; and to provide feedback on this website or advise us of errors.