Varying entries in the ARTG: medical devices and IVDs

Varying entries in the ARTG [PDF, 883.72 KB]

Varying entries in the ARTG [Word, 2.32 MB]

This user guide is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.

It is important that the information included in the ARTG is: 

• kept up-to-date and 
• correct from a public health, regulatory and transparency point of view. 

When any information included in the ARTG has changed, the sponsor needs to request us to vary the respective ARTG entry.

Changes

July 2024
Update and change of contact us email address