Australia TGA Publishes Latest Guidance on Reclassification of Active Implantable Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published the latest document on the reclassification of active implantable medical devices (AIMD) with information on transitional arrangements and obligations, in March 2022. 

Active implantable medical devices are required to be reclassified from Class AIMD to Class III, and this has been in effect since 25 November 2021. 

The latest guidance document includes a section on annual reporting requirements, stating that there are annual reporting requirements for the first 3 years of inclusion in the Australian Register of Therapeutic Goods (ARTG). 

More details can be found in “Reclassification of active implantable medical devices (AIMD): Guidance on the transitional arrangements and obligations, March 2022”:  

Share on Linkedin Send to Email

Questions? Request more information from our specialists!

Contact Us

More News