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Varying entries in the ARTG - medical devices and IVDs
Version 1.0, November 2016
It is important that information included in the ARTG is kept up-to-date and is correct from a public health, regulatory and transparency point of view. 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 the:
- information entered on the ARTG is not correct or no longer correct
- manufacturer’s details (e.g. name and/or address) have changed
- GMDN code was made obsolete and the manufacturer decided to change to a current relevant GMDN code*
- intended purpose of the device was changed by the manufacturer
- manufacturer has added variants
- manufacturer’s evidence identifier was changed (e.g. split or combine certificates or new ID following sponsors transfer**)
- manufacturer amended the Unique Product Identifier (UPI) and/or number of devices of the kind
- sponsor wants to vary the list of IVD devices included in ARTG entry
* The GMDN code must be current at the time when an application for ARTG inclusion of a kind of medical device is submitted to the TGA, and the code is expected to remain the same for the whole life of ARTG entry. TGA does not require the sponsor to amend the GMDN code if it becomes obsolete. However if the manufacturer decides to vary the GMDN code because it was made obsolete by the GMDN Agency, the sponsor may require the TGA to vary this information on the ARTG by submitting an application to the TGA.
** This guidance does not cover sponsor transfers and/or change of sponsor’s name. For requirements related to the sponsors transfers refer to Regulation 10F of the Therapeutic Goods Regulations 1990, and our guidance on Sponsor transfer and change of sponsor name amendments.
Decisions about variation of ARTG entries are made under Section 9D of the Therapeutic Goods Act 1989. We will always vary the ARTG entry if the sponsor requests a variation that:
- reduces the class of persons for whom the kind of medical device is suitable, or
- adds a warning, restriction or precaution.
We will not accept a request for variation if:
- the result of the proposed variation would be that the device is no longer a device of the same kind, or
- the proposed variation indicates any reduction in the quality, safety or performance of the medical device for the purposes for which it is to be used.