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Medical devices regulation basics
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. These sponsors take legal responsibility for the supply of their medical devices in or from Australia.
Medical device sponsors must have their product in the ARTG unless the product is exempt or excluded.
The first step in doing business with us is to set up an eBusiness Services account.
Once a sponsor has all the information, they can apply via TGA eBusiness Services.
Get information about changes to Australia's medical device regulations:
- Regularly check the TGA
- Keep up with
- Follow the progress of Medical Device Reforms
Regulatory consultants and industry associations
We do not provide details of regulatory affairs and therapeutic goods regulations consultants. Sponsors and manufacturers might find it helpful to contact a relevant industry association.
We do not endorse these associations.
- Association of Regulatory and Clinical Scientists Australia (ARCS)
- Australian Dental Industry Association (ADIA)
- Australian Self-Medication Industry Association (ASMI)
- Medical Technology Association of Australia (MTAA)
- ACCORD Australasia
Providing feedback to the TGA
Apply to join the Authorised Prescribers Scheme
You can prescribe unapproved products in certain circumstances. Find out who can apply, what you can prescribe and what to do before you apply.