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.

Stay informed

Get information about changes to Australia's medical device regulations:

• Subscribe to updates 
• Regularly check the TGA News and Community
• Keep up with Consultations
• 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)
• AusBiotech
• Australian Dental Industry Association (ADIA)
• Australian Self-Medication Industry Association (ASMI)
• Complementary Medicines Australia (CMA)
• Pathology Technology Australia (PTA)
• Medical Technology Association of Australia (MTAA)
• ACCORD Australasia

Providing feedback to the TGA

Report a problem or side effect
Reporting adverse events (side effects to medicines and problems with medical devices) helps make medicines and medical devices safer for everyone.

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.

Contact us
Make enquiries, provide feedback, and alert us of errors.

More information

• Fees and payments
• Medical device inclusion process
• Overview of medical devices and IVD regulation
• Other therapeutic goods (such as disinfectants and tampons)
• Report a perceived breach or questionable practices