While the new regulatory framework comes into effect very soon (25 February 2021), there are arrangements in place to ensure you can continue to supply devices while you apply for them to be included in the ARTG.
If you are responsible for fulfilling the regulatory requirements for any of the devices that you currently use, then there are three steps that you will need to take.
Step 1 (to be done before 25 August 2021)
Submit a custom-made medical device notification to the TGA.
If you are making a device that is currently categorised as a custom-made medical device but will be categorised differently under the new framework, you must ensure that you have notified the TGA that you are making or supplying this device. If you fail to notify the TGA, you will not be able to apply to transition the device to the new system.
The TGA initially advised that this needed to be done before 25 February 2021, but the deadline has now been extended.
Please note that there are regulatory requirements for custom-made medical devices which will apply once you have submitted a notification to the TGA. That will include an Annual Report covering the period from 25 February to 30 June 2021 that is due to be submitted to the TGA by 1 October 2021. We will provide members with more information about this in the coming months.
Any devices that you fail to notify the TGA about, you will need to stop using from 26 August 2021 until they are listed in the ARTG.
Step 2 (to be done before 25 August 2021)
Submit a notification to access transition arrangements to the TGA.
Once you have completed step 1, you will then need to apply to transition the device so that you can continue to supply it until it is included in the ARTG. If you register for transition and later find that you don't need to proceed with including the device, then the notification form will simply become redundant. You will not be compelled to include a device that is registered for transition if you later choose not to proceed with listing it in the ARTG.
Step 3 (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 two steps to allow continued supply of your devices while you transition your device for inclusion in the ARTG.