TGA Updates Guidance on Varying ARTG Entries: Key Points for Medical Device and IVD Manufacturers
The Therapeutic Goods Administration (TGA) has released Version 6.0 of its guidance document “Varying entries in the ARTG – Medical devices and IVD medical devices”, providing clear instructions for when and how sponsors must apply for variations to existing entries in the Australian Register of Therapeutic Goods (ARTG).
What’s New – and What It Means for Manufacturers
This update applies to all device classes, including IVDs, and aims to ensure ARTG data remains accurate, complete, and aligned with regulatory requirements. The revised document outlines:
When Is an ARTG Variation Required?
Sponsors must consider a variation application if any of the following changes occur:
Manufacturer details (name or address)
Intended purpose of the device (broadened, reduced, or updated indications)
Addition or removal of product variants
Changes to the total number of devices covered
Changes to the Unique Product Identifier (UPI)
Updates to GMDN codes
Revisions to the list of IVDs included in the ARTG entry
Incomplete or incorrect ARTG entries must be corrected via an application under section 9D(1) of the Therapeutic Goods Act 1989.
Key Limitations: When a Variation Is Not Enough
The TGA will reject a variation request if it would:
Result in a device of a different kind (per section 41BE of the Act)
Indicate a reduction in quality, safety, or performance
In these cases, a new ARTG inclusion application is required.
Changes to Manufacturer or QMS
When requesting a change to the manufacturer’s name or address, the TGA will assess whether the Quality Management System (QMS) and control over design and production remain unchanged. If not (e.g. after acquisition or restructuring), a new inclusion application may be necessary.
Intended Purpose & GMDN Codes
Changes to the intended purpose must not alter the classification or kind of device. These changes require careful justification.
Sponsors are not required to update obsolete GMDN codes, but may choose to apply a more relevant, active term—as long as the change does not affect the intended purpose or device type.
Application Pathways
Three application types are defined:
Class III/AIMD Variation Application Form
Device Change Request (DCR) – for all device classes
IVD Variation Application Form
Only the ARTG sponsor or authorised agent can submit a variation. All changes must be approved by the TGA before being implemented.
Why It Matters
Manufacturers and sponsors should prioritise:
Lifecycle management of ARTG entries
Early assessment of whether a variation or new inclusion is required
Alignment between QMS, intended purpose, and regulatory documentation
Poorly managed changes can result in non-compliance or market delays.
Read the full document below.
