The way that custom-made medical devices are regulated is changing.
A new framework for regulating
personalised medical devices will commence on 25 February 2021. Under the new framework most custom-made
medical devices that are currently supplied in Australia will no longer be exempt
from inclusion in the Australian Register of Therapeutic Goods (ARTG). Any devices that will continue to be exempt
will need to meet new requirements.
If you manufacture, import or supply a custom-made medical device,
you will be impacted by the changes and should review the guidance available on
the TGA's website.
There is a transition period available if you are currently
manufacturing or supplying custom-made medical devices and will now need to
seek TGA approval and include your devices in the ARTG. If you access the
transition period, you will have until 1 November 2024 to submit an application
to the TGA for inclusion in the ARTG. Accessing the transition period is a
two-step process:
1.
You must notify
the TGA that you are a manufacturer or supplier of custom-made medical devices;
and
2.
You must then apply
for the transition period before 25
August 2021.
Other changes introduced by the new framework include:
More information about the changes is available on the TGA website: https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices
Ballarat Health Services will be partnering with the TGA in
the coming months to provide more information to AT suppliers and
practitioners, including a dedicated educational webinar if there is sufficient
interest. You can inform the TGA of your interest through this short
survey. For now, you are encouraged to make sure you have notified
the TGA if you are manufacturing, importing or otherwise supplying custom-made
devices to ensure you will be eligible for the transition period if you need to
access it.
What changes we are making as a result of this regulatory
change?
SWEP will update our quotation template, and providers will
now be required to confirm whether or not any of the items requested are
required to be registered on the ARTG. If the provider uses their own template,
this information will be required on the quote.
Please click here for more information from the
TGA
Kind Regards
SWEP Management Team
