If you make or supply custom-made medical devices the changes to TGA regulation will impact you.
New legislation is taking effect from 25 February 2021, which will affect how custom-made medical devices can be supplied from that date. In particular:
What is the difference between a custom-made medical device and a patient-matched medical device?
only some custom-made medical devices will continue to be exempt from the regulatory requirements for all other medical devices
- most custom-made medical devices will now be called 'patient-matched medical devices', will not be exempt and must be entered in the ARTG
A personalised medical device is a medical device which is designed and manufactured to meet the particular anatomical, physiological or pathological features or needs of a single individual.
After 25 February 2021, for regulatory purposes, there will be multiple categories of personalised medical devices including 'patient-matched medical devices' and a new, narrower category of 'custom-made medical devices'.
After 25 February 2021, the new category of 'custom made medical devices' will only capture rare, one-off, bespoke pieces that are designed and manufactured for patients with unique anatomical, physiological or pathological features or needs, for whom any other medical device (including any patient matched medical device) would not be suitable.
How do the changes affect me?
Manufacturing of Medical Device in-house
The changes do impact practitioners who mill ceramic restorations, 3D print implant surgical guides or fabricate retainers in house. The changes also impact practitioners who fabricate whitening trays or mouthguards in-house, where the intended purpose of these devices is therapeutic.
If you currently produce or fabricate any kind of custom-made medical device in the course of your practice you must do the following (if you have not already done so):
1. Notify the TGA that you produce what is currently classified as a custom-made medical device. The online notification form – Notification Form 1 - is available here.
The TGA has advised a moratorium is in place and this step can now be completed up until 25th August 2021 .
We note the form requires your contact details, a description of the devices you make (eg: clear orthodontic retainer), the GMDN and classification. If you do not know or have no access to the GMDN code you can enter ‘unknown’ in this box. Most medical devices manufactured by dentists will be Classification ‘Class Ia’ or ‘Class 11a’, however you can click on the link to the TGA online tool to confirm this is accurate for your devices.
2. If you supply any patient-matched medical device after the regulatory changes take effect on 25 February 2021, and you would like to continue to supply the device after that date, you must also notify the TGA that you intend to transition the device. This will involve submitting an application to enter the device on the ARTG any time before 21 November 2024. The online notification form – Notification Form 2 - is available here. This must be done before 25 August 2021.
3. Obtain the documentation you need to apply to include each patient-matched medical device which you supply on the ARTG. This will include evidence from the manufacturer that appropriate conformity assessment procedures have been applied and that the device complies with the Essential Principles. Once gathered, you must submit the documentation with an application for inclusion on the ARTG before 21 November 2024. This must be done before 21 November 2024.
Supply of Medical Device Manufactured for you by third party
If you use or supply a patient-matched medical device after 25 February 2021 which is produced or manufactured for you by a third party, you will need to determine who is, or will be, the 'sponsor' of the medical device going forward. The supply of dentures which are manufactured by a third party would fall within this category.
The sponsor is the person or entity who is responsible for supplying the device within Australia (other than on behalf of another person or entity). The sponsor can be the same person or entity which manufactures the device, or separate person or entity. Steps 1 to 3 above must be completed however, it is the responsibility of the sponsor to complete the steps.
If you purchase custom-made medical devices from a third party for use in the course of your practice, it is possible that you are not the sponsor. If so, you are not required to complete steps 1 to 3 above. However, you must not purchase or supply medical devices from that sponsor if they do not undertake the steps described. It is recommended that you seek assurance from any of your suppliers to this effect.
If you purchase custom-made medical devices from a third party who is based outside of Australia, you may be the sponsor of the medical devices in Australia and need to complete the steps.
What do I do if I want to supply new custom-made medical devices or patient-matched medical devices?
A new patient-matched medical device may not be supplied in Australia after 25 February 2021 unless it is entered in the ARTG.
New medical devices which meet the new, narrower definition of a 'custom-made medical device' after 25 February 2021 may be supplied without being entered in the ARTG however, the manufacturer and sponsor (the person or entity responsible for supplying the device in Australia) must:
- notify the TGA of the kind(s) of device(s) which they intend to manufacture and supply;
- report the number of devices supplied each financial year to the TGA;
- allow the TGA to inspect the facility(ies) where the devices are produced;
- retain copies of all documentation about the device for 5 years (for non-implantable devices) or 15 years (for implantable devices);
- report all adverse events to the TGA; and
- ensure the manufacturer of the devices provides certain information about the device to each recipient.
For more information
TGA Guidance, 'Personalised medical devices (including 3D-printed devices) Regulatory changes for custom-made medical devices' (link)
Notification Form 1, 'Custom-made medical devices' (link)
Notification Form 2, 'Transition arrangements for custom-made medical devices' (link)
You can contact the TGA directly with any questions about the framework or the submission of any of the forms via email@example.com
The TGA is also developing a regulatory framework for Medical Device Production Systems (MDPS). MDPS refers to a system supplied to a health professional or healthcare facility so that personalised medical devices can be manufactured by a health professional (or other suitably qualified person within the healthcare facility).
Under the new framework, the manufacturer of an MDPS, and not the user of the system, will be considered to be the legal manufacturer of any devices produced using the system, and will be responsible for obtaining regulatory approval for the MDPS. This regulatory framework is not yet complete and even if your device may fall within this system in the future, you still need to register it now. We will provide you with more information as it becomes available.