If an ARTG entry contains information that is incomplete or incorrect, a sponsor can request that the entry be varied under section 9D of the Act.
When information included in the ARTG has changed because of the manufacturer transitioning their device(s) to EU MDR certification, the sponsor should consider if their respective ARTG entry(s) requires updating.
DCR applications
A DCR application form can be used for all classes of devices.
You may submit a DCR application and request for the TGA to vary the ARTG entry if any of the following occurs:
- Information entered on the ARTG is incomplete or incorrect
- Manufacturer details (for example name and address only) have changed
- Intended purpose of the device was changed by the manufacturer (for example broadening and reducing clinical indications)
- When the intended purpose in the ARTG entry requires modification to reflect the devices included under that entry
- Change to GMDN code by the manufacturer to a more relevant, active, and or preferred code.
- Manufacturer evidence identifier requires updating
Note
The classification and the legal manufacturer of a medical device in the ARTG cannot be varied. A new application for inclusion would be required as this change is considered a new ‘kind’ of device.
Variation applications
A variation form is designed to request variation of the information included in the ARTG for a specific device of the kind of which is either Class III or Class AIMD, such as changes to the UPI, total number of devices, functional description and/or product variant list.
You may submit a variation application and request the TGA to vary the ARTG entry if any of the following occurs:
- The Unique Product Identifier (UPI) has changed
- The total number of devices has increased or decreased as a result of changes to variant specifications
- The functional description has changed
- The product variant list has changed