Varying an ARTG Entry
Overview
An ARTG entry must accurately reflect the current state of the device and the sponsorship arrangement at all times. When changes occur that affect the information in an ARTG entry, the sponsor must assess whether a formal variation application is required, whether a notification to the TGA is sufficient, or whether a new ARTG application is needed. Getting this assessment right is important — making significant changes to a device without the appropriate variation or new application is a breach of ARTG conditions and can constitute supply of an unapproved device.
Changes That Require a New ARTG Application
Some changes are so significant that the existing ARTG entry cannot be varied — a new application is required:
- Change of sponsor (the new sponsor must hold their own ARTG entry)
- Change of manufacturer (a different legal entity)
- Change in device classification (the new class requires a new application pathway)
- Addition of a new intended purpose that changes the device's risk profile or classification
- Changes that result in the device becoming a different kind of medical device
Changes That Typically Require a Variation Application
The following changes typically require a formal variation application to update the existing ARTG entry:
- Adding new device models or variants to an existing ARTG entry (where they are the same "kind" of device)
- Change of manufacturer's address or manufacturing site
- Update to conformity assessment evidence (e.g., new CE certificate replacing an expired one)
- Changes to labelling beyond minor corrections
- Changes to conditions of inclusion imposed by the TGA
- Change of sponsor's name (not a change of legal entity — just a name change)
Changes That May Not Require a Variation
Minor changes may not require a formal variation but should still be assessed:
- Minor typographical corrections to non-critical labelling information (assess against TGA guidance)
- Updates to the sponsor's contact details within the same legal entity
- Changes to the device's instructions for use that do not affect safety, performance, or intended purpose
The TGA's guidance on ARTG variations should be reviewed for each specific change type — the assessment is not always straightforward.
How to Submit a Variation
Variation applications are submitted through the TGA Business Services (TBS) portal. The application must include:
- Identification of the ARTG entry being varied
- Description of the change
- Justification for why the change does not require a new application
- Updated supporting documentation relevant to the change (e.g., updated conformity assessment certificates, updated labelling)
Fees may apply depending on the type of variation. The TGA reviews the variation and, if satisfied, updates the ARTG entry.
The "Significant Change" Assessment
Before making any change to a device, manufacturers must assess whether the change constitutes a significant change under the MD Regulations. A significant change is one that could affect the safety, performance, or classification of the device. A significant change must be notified to the TGA and may require:
- A variation application to update the ARTG entry
- A new conformity assessment application
- A new ARTG application (if the device becomes a different kind)
Manufacturers must notify their Australian sponsor of any significant change so the sponsor can take the appropriate regulatory action. Changes implemented without appropriate TGA notification are a breach of ARTG conditions.