Therapeutic Goods Administration (TGA) - FAQ's

Q: What precisely does it mean when a device is listed on the ARTG registry or commonly referred to as TGA approved?
A: It means the Australian Importer or Australian manufacturer of a particular device (also called Australian TGA Sponsor of the device) has the device listed on the ARTG registry, has approval from TGA to manufacture or import that device to Australia.

If a particular device is imported by 5 different importers, that particular device needs to have 5 different ARTG numbers or 5 TGA approvals, each importer has to have its own. View TGA approval as authorisation to import and sell.

Q: Can I buy a TGA approved device from overseas?
A: No. No overseas manufacturer or any supplier can apply or have a device listed on the ARTG registry. Only Australian registered manufacturers and Australian registered importer companies can apply and have a device included on ARTG registry (TGA approved).

No company or private person can import a device, not even for testing or demo purposes. The device must first be included on ARTG registry under its name as importer, before importation. Customs have rights to refuse entry.

Q: I have seen this device sold in Australia and included on the ARTG registry, I have found the manufacturer, can I buy it direct from them?
A: No as the ARTG number only gives the right to import by the ARTG number holder. You need to apply for ARTG number of your own (for your own TGA approval) if you want to legally import that device.

Q: I have bought a second hand device, how do I know if it’s included on ARTG registry, if it is TGA approved?
A: Always ask the seller to provide you with the original purchase Tax Invoice where the device’s ARTG number is displayed, you need it as a proof that device is legal and included on ARTG registry.

Q: In the case of a TGA audit of a clinic, how can the owner prove to TGA the device in question is legal and TGA approved ?
A: TGA always requires the ARTG number of the device in question, as proof of a legitimate import and purchase, the valid Australian Tax Invoice issued by the company that has the device listed on the ARTG registry. Without that Tax Invoice TGA will consider your device not TGA approved, as you are unable to prove the legal importation of that device.

Q: My device is FDA Approved, is that OK ?
A: No. FDA approval has no bearing in Australia. FDA in USA is like TGA in Australia. FDA is only valid in states and territories of the USA. It has no meaning in Australia.

Q: Can I call the TGA to find out if any particular device requires TGA approval? Can I just call them and get more detailed information?
A: You can try but do not expect much or any legally valid info based on a phone call. TGA is a regulator not an educator.

To determine if a device is medical or not, or if it needs to be included on the ARTG registry, can not be determined by a single phone call or a short conversation. There is much more to it.. It requires a medical device assessor to study the manual, indications, contra indications, see the device’s and manufacturer’s certifications etc…

The TGA will generally advise anybody who would like to get more information on a device to contact an approved medical device assessor. A list of TGA approved medical device assessors can be found on TGA’s website. They can give you the correct answer you can legally rely on, however it is not a free service.

As a clinic or business owner the TGA expects you to obey the law and regulations. Not knowing the law or regulations is not an excuse.

Q: I use many devices that I have purchased online and they work fine, what can go wrong?
A: Even one injury or one valid customer complaint, Treatment Liability Insurance will refuse to pay if un-approved devices have caused injury. This is always in the insurance policy fine print. You are liable for everything and can also receive a hefty TGA fine.