Vary medical device entries in the ARTG (includes IVDs)

When any information included in the ARTG has changed, the sponsor should consider if they need to request the TGA to vary the respective ARTG entry.

There are many reasons why sponsors may require variation of their ARTG entries, for example:

• information entered on the ARTG is not correct
• manufacturer details (for example, name or address) have changed
• the manufacturer replaced an obsolete GMDN code with a current GMDN code
• the manufacturer changed the intended purpose of the device
• the manufacturer added variants of the device
• to link the ARTG entry to different manufacturer’s evidence (for example, to split or combine certificates or because of a sponsorship transfer)
• the manufacturer changed the Unique Product Identifier (UPI) or number of devices of the kind under the ARTG entry
• to vary the list of IVD devices under the ARTG entry

Key information

• Varying entries in the ARTG - medical devices and IVDs
• Changing the sponsor of therapeutic goods