If you are responsible for fulfilling the regulatory requirements for any of the devices that you currently use, then there are two steps that you will need to take.
Step 1 (to be done before 25 August 2022)
If you are importing materials, components or devices or manufacturing devices with materials not already on the ARTG and exceed the exemption for very low volumes of up to five (5) devices, you will need to submit a notification and application for transitional arrangements by 25 August 2022.
You can find detailed information including a step-by-step guide with screenshots in the Submitting a custom-made medical device / patient-matched medical device transition notification Guide provided by the TGA.
The TGA’s new, improved custom-made medical device database requires you to use a valid GMDN code. GMDN code tables are available in the database for you to search and you can also refer to the ASO GMDN Code table and ASO Guide for details.
Step 2 (to be done before 21 November 2024)
Submit an application for inclusion in the ARTG.
The final step is to ensure you have appropriate evidence of conformity assessment and submit an application for inclusion in the ARTG. However, you must complete the above step to allow continued supply of your devices while you transition your device for inclusion in the ARTG.
If, after reading the information you have any questions, please email [email protected]. You can also contact the TGA directly for further guidance or with any questions by emailing [email protected].
