The bulk of orthodontic devices you supply to patients will now require TGA approval and to be included in the ARTG.
Essentially, each “kind of device” will ultimately need separate TGA listing and approval. The duty to apply for TGA approval, payment of fees, and submission of relevant paperwork to the TGA each year rests with the sponsor of the device (in most cases the manufacturer will also be the sponsor).
The sponsor of the device is the Australian based legal entity responsible for ensuring that a medical device complies with the regulations. Anyone who manufactures medical devices in Australia (including health professionals) can choose to either act as the sponsor of their medical devices themselves, or choose to assign this responsibility to another Australian entity.
Overseas manufacturers must always assign the responsibilities of a sponsor to an Australian legal entity. An inclusion in the ARTG is for a “kind of device”. This means that providing your devices have particular characteristics in common, you will only have one inclusion in the ARTG. You can read the definition of “kind of device” HERE.
It is important that you contact your suppliers now to ensure they are aware of these changes and are taking the necessary steps required by the TGA so you can continue to supply their devices to patients. An information sheet is available which you may wish to pass on to your suppliers if they are unaware of the regulatory changes - you can access the information sheet HERE. If you are sourcing devices directly from an overseas supplier, you will need to take on the responsibility of acting as the sponsor of these devices.
When you are NOT required to take action with the TGA
In the following situations, you must check with your supplier to ensure they are aware of these changes and are meeting their regulatory obligations. If they are not, then you must either include the devices in the ARTG yourself or cease using the device/s from 25 August 2021.
You can search the ARTG HERE to check whether your supplier has registered the devices you currently supply, or the Medical Device Production System (MDPS) you use to make devices in-house (noting that MDPS's will not be able to be included in the ARTG for 18 months to 2 years after the new framework commences).
- Devices manufactured in Australia (not in-house): if a device you use is manufactured by an Australian company/laboratory, and they have taken responsibility for the TGA approval and ARTG listing.
- Devices manufactured overseas by a company that has a presence within Australia: if a device you use is manufactured by an overseas laboratory/company and this company has a presence within Australia e.g. commercial aligners (such as Invisalign and Ormco), the devices will most likely already have TGA approval via the product importer.
- Devices manufactured in-house using a system currently listed in the ARTG as an MDPS and following the manufacturer’s instructions: if a device you use is manufactured within your orthodontic practice using a MDPS and in accordance with the manufacturer’s instructions, and that system is already listed in the ARTG (e.g. cerec unit), then you will not need to include the devices you produce with that system in the ARTG.
When you ARE required to take action with the TGA
- Devices manufactured overseas by a company that does NOT have a presence within Australia: if you directly import a device manufactured by an overseas laboratory/company, then you as the orthodontist are deemed to be the “sponsor” and you will be required to include the device in the ARTG and meet ongoing responsibilities as the device's sponsor.
- Devices manufactured in-house using an MDPS currently NOT listed in the ARTG or NOT in accordance with the manufacturer’s instructions: if a device you use is manufactured within your practice e.g. via the use of a 3D printer or using an MDPS that is registered with the TGA but outside the manufacturer’s instructions, then you as the orthodontist are deemed to be the “manufacturer” and you will be required to take action with the TGA.
- Devices manufactured in-house: if a device you use is manufactured within your practice e.g. using stone or a 3D printer, then you as the orthodontist are deemed to be the "manufacturer". You will need to determine whether you wish to act as the sponsor of your devices, or if you will engage another party to act on your behalf.