Guidance from TGA on personalised medical devices
4 Jul 2024
Following the 2021 release of the updated Therapeutic Goods (Medical Devices) Regulation, the APodA has been actively collaborating with the Therapeutic Good Association (TGA) on behalf of our profession.
Recognising the significant impact of this legislation, the APodA has developed an up-to-date Therapeutic Goods Member Resource page, featuring a new interactive section to assist you further.
Key points for manufacturers of personalised medical devices
If you were supplying a custom-made medical device before February 2021 that now meets the definition of a patient-matched medical device, you may be eligible for transition arrangements to support your move to ARTG inclusion.
To qualify for the transition period, you must:
- Have been manufacturing or supplying the device before the new framework commenced on 25 February 2021.
- Notify the TGA of your intention to access the transition arrangements before 1 November 2024.
- Eligible patient-matched medical devices for which transition notifications have been made can continue to be supplied without ARTG inclusion until 1 July 2029. After this date, all patient-matched medical devices must be included in the ARTG or have a valid application for inclusion underway.