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 the TGA site for an overview of medical devices
- See the Decision Tree diagram to see what type of device it is.
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.
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.
4. Notify the TGA.
Due to the advocacy efforts of the ASO and Dental Sector Working Group the requirement for orthodontists to register patient-matched medical devices has been removed, with a few exceptions.
If you are importing materials, components or devices or manufacturing devices with materials not already on the ARTG and exceed the exemption for very low volumes of up to five (5) devices, you will need to submit a notification and application for transitional arrangements by 25 August 2022.
You can find detailed information including a step-by-step guide with screenshots in the Submitting a custom-made medical device / patient-matched medical device transition notification Guide provided by the TGA.
The TGA’s new, improved custom-made medical device database requires you to use a valid GMDN code. GMDN code tables are available in the database for you to search and you can also refer to the ASO GMDN Code table and ASO Guide for details.
If, after reading the information you have any questions, please email [email protected]. You can also contact the TGA directly for further guidance or with any questions by emailing [email protected].