The bulk of orthodontic devices you supply to patients will now require TGA approval and to be included in the ARTG.
Your initial steps are to determine how the regulatory changes to custom-made medical devices affects the devices you currently use. From there, you need to determine who is responsible for fulfilling the regulatory requirements for these devices – this will either be you or your supplier.
Where to start
1. Assess each device that you use.
You will need to assess each device that you use in your practice and decide if it meets the definition of a medical device and if so, which of the new personalised medical devices categories it fits into.
- See this page of the TGA site for an overview of medical devices: https://www.tga.gov.au/sme-assist/medical-devices-regulation-introduction
- Determine whether your device is a medical device by using this tool: https://www.tga.gov.au/my-product-medical-device#1
- See the Decision Tree diagram to see what type of device it is: https://www.aso.org.au/sites/default/files/uploaded-content/website-content/tga_doc_appendix_1_-_decision_tree.pdf
2. Decide who the sponsor is.
If your device is a medical device, you then need to decide who the Sponsor of that device is.
- The “sponsor” is the Australian-based legal entity responsible for ensuring that a medical device complies with the regulations. In most cases the Sponsor is also the manufacturer.
- If you source a device from an Australian sponsor, it is their responsibility to list the device in the ARTG (if they do not do this then you will have to stop using that device after 25 August 2021).
- If your device has not been included in the ARTG by an Australian based sponsor, it is likely that you will be responsible.
- You can search the ARTG to see if your device is already listed: https://www.tga.gov.au/australian-register-therapeutic-goods
If you are not the Sponsor of a medical device, your next step is to contact the manufacturer/sponsor and ensure they are aware of the new regulatory requirements and that they are complying with them.
3. If you (the orthodontist) are the sponsor.
If you are the sponsor of a medical device, then your next step is to determine the classification of the device.
- Determine your devices Classification using this TGA tool: https://www.tga.gov.au/sme-assist/what-classification-my-medical-device#109
- Listing in the ARTG is for a “kind” of medical device, which means that devices with certain characteristics in common can be grouped together under one listing. See this page of the TGA site for a definition of “kind” of medical device: https://www.tga.gov.au/kind-medical-device
4. Notify the TGA.
It is an existing regulatory requirement to complete a simple online form to notify the TGA that you are sponsoring a device that is currently regulated as a custom-made medical device. This must be completed first and it must be done by 25 August 2021. If you are unsure whether you have completed this previously, the TGA advises it is best to err on the side of caution and complete it again. Remember that this form is completed only for each “kind” of medical device.
You can access the notification form here: https://forms.business.gov.au/smartforms/servlet/SmartForm.html?formCode=custom-made-medical-
Once you have notified the TGA of your devices, you will then be eligible to apply to transition them to the new system. The application to transition is a slightly more detailed form which must also be completed before 25 August 2021. Please note this can only be done after you have completed the notification form above.
You can access the transition form here: https://consultations.health.gov.au/tga/accessing-transition-arrangements-patient-matched/