ARTG User Guide Updates for Custom & PMMD Devices

User guides have been updated to include the transition eligibility content. While custom made devices are now exempt from requirement to be included in the Australian Register of Therapeutic Goods (ARTG), they are not exempt from TGA regulation. New definitions for custom-made devices commenced on 25th February 2021, where a lot of medical devices defined as custom-made now meet the definition of patient-matched medical device (PMMD). From 1st July 2029, PMMD are no longer exempt from ARTG inclusion. There is a low-volume exemption for PMMD’s that are supplied in volumes of five (5) or less per ‘kind’ – these devices do not require inclusion in the ARTG.

The transition period for PMMD’s is open until November 1st, 2024 – meaning that if manufacturers want to take advantage of the transition period after 1st July 2029, TGA must be notified of this intention by submitting a notification form. After 1st July 2029, PMMD’s must be included in the ARTG before they can be imported into and exported out of Australia.

The notification to TGA can be completed online.

Where are the ARTG User Guide Updates?

• • Understanding personalized medical devices rules (including 3D printed devices) – Version 7.0, October 2024
  • How to submit a custom-made medical device/patient medical device notification – Version 3.0, October 2024
  • Refinements to the Personalised Medical Device Framework V3.0, October 2024

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If you would have any questions about the ARTG user guide updates for custom and PMMD medical devices, contact us so our regulatory team can assist you. 

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