The way that custom-made medical devices are regulated in Australia is changing, and from 25 February 2021, a new framework for personalised medical devices came into effect.
Under the current legislation, custom-made medical devices are exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG). However, orthodontists who have been manufacturing and/or supplying medical devices that fall into the current custom-made medical devices category, should have previously notified the TGA of these devices as you are legally obliged to submit a custom-made medical device notification form via the TGA website within 2 months of starting to manufacture and/or supply it.
For anyone who has failed to do this in the past, you will need to submit a custom-made medical device notifcation form, before applying to transition your device so that it can be included in the ARTG. You will need to do this before 25 August 2021.
The main impact of the regulatory changes is that most of the devices currently being supplied as custom-made medical devices will need to be approved by the TGA and included in the Australian Register of Therapeutic Goods (ARTG). As a general guide, for anyone manufacturing, importing or supplying more than five (5) of a kind of medical device in a year, it is unlikely that the device will meet the new definition of ‘custom-made’ under the new framework. Instead, it will likely meet the definition of a ‘patient-matched’ medical device.
What are the categories under the new personalised devices framework?
Under the new framework, there are four categories which your medical devices will fit into:
- custom-made - new definition and regulatory requirements apply
- patient-matched - new definition and required to be included in the ARTG
- adaptable - continues to be required to be included in the ARTG
- devices produced using a Medical Device Production System (MDPS) - a new concept that is currently being developed and will be required to be included in the ARTG.
For orthodontists, some of your devices will fall into the new definition of custom-made, most will move into the patient-matched category, some will fit into the adaptable category and some will fit into the devices produced using an MDPS category.