The TGA has developed a new framework for medical devices which are designed and manufactured for individual patients. Collectively these changes are known as the ‘personalised medical devices framework’.
What this means
Under the new framework most medical devices that are currently supplied in Australia, including foot orthoses, will no longer be exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG) which is currently the case, and instead they now must be included.
This new framework for regulating personalised medical devices came into effect on 25 February 2021, followed by a transition period for all devices to be registered on the ARTG.
How the transition period works
If you are a manufacturer of an orthotic device you must apply for this transition period by 25 August 2021 and then you will have until November 2024 to register devices on the ARTG. The bottom line is that if you manufacture, import or supply a medical device, you will be impacted by the changes and should review the guidance available on the TGA’s website.
The impact of these changes
These changes usher in a new definition for categories of personalised medical devices for the TGA only. What was previously commonly referred to as ‘custom-made’ devices will now fall under the category of 'patient-matched' devices. The TGA has confirmed that orthotics that podiatrists provide, whether custom or prefabricated, will fall within the patient-matched devices category.
What falls within a patient-matched category?
The TGA define a patient-matched medical device as:
A medical device that meets the following requirements:
- It is matched to a patient’s anatomy within a specified design envelope using techniques such as scaling of the device based on anatomic references, or by using the full anatomic features from patient imaging; and
- It is typically produced in a batch through a process that is capable of being validated and reproduced; and
- It is designed and produced under the responsibility of a manufacturer even though the design may be developed in consultation with an authorised healthcare professional.
Note: There is a category to list custom devices, but this is for one-off devices, not custom orthotics.
Who is the manufacturer?
The manufacturer of a patient-matched device is the person or business responsible for listing that device on the ARTG. This means if you get your orthotics from an orthotic lab – it will be their responsibility to list that device on the ARTG.
How this will affect podiatrists?
There are two possible scenarios to be aware of.
Scenario 1: If you supply orthotics from an orthotic manufacturer
The majority of podiatrists will be supplying patient-matched devices. These are devices which you receive from an orthotic manufacturer. These devices will be required to be registered on the ARTG by the orthotic manufacturer. This applies to both custom orthotics and prefabricated orthotics. If this is the case, it is the responsibility of the orthotic manufacturer to register these devices and you do not need to do anything at this stage.
Note that the TGA define the manufacturer as:
“The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person’s name, whether or not it is the person, or another person acting on the person’s behalf, who carries out those operations.”
The TGA also defines the orthotic manufacturer as the manufacturer of prefabricated devices noting that:
...a person is not the manufacturer of a medical device if
(a) the person assembles or adapts the device for an individual patient; and
(b) the device has already been supplied by another person; and
(c) the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following:
(i) the labelling on the device;
(ii) the instructions for using the device;
(iii) any advertising material relating to the device;
(iv) technical documentation describing the mechanism of action of the device.
These definitions are section 41BG of the Therapeutic Goods Act 1989. You can read the full legislation here.
Scenario 2: You manufacture your own orthotics
You will need to register these devices with the TGA on the ARTG. These devices will still fall within the category of patient-matched devices. The changes came into effect on 25 February 2021, however, transition arrangements are in place until 1 November 2024.
As shared previously in this article, you must apply for the transition period through the TGA before 25 August 2021 to allow you time to familiarise yourself with the changes and register your devices.
If your device is manufactured overseas please see the Medical device inclusion process | Therapeutic Goods Administration (TGA).
The APodA is working collaboratively with the TGA to ensure all information relevant to podiatrists is communicated. For further information, please visit our website.