TGA publishes information on varying entries in the ARTG for medical devices and IVDs

On 30th November 2016, the Australian Therapeutics Goods Administration (TGA) published a guidance to companies to keep information included in the Australian Register of Therapeutic Goods (ARTG) up-to-date. The ARTG is a searchable record of the contents and classification details of therapeutic goods that can be supplied in Australia. The search function can be used for medicines and medical devices. The publicly accessible version of the ARTG can be found here.

When any details in the ARTG have changed, it is important that the sponsor keeps in mind the need to request a change to the affected ARTG entry.

Reasons for variations of an ARTG entry might include:
• 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 guidance provides information on how to update an ARTG entry; it defines the process, forms and fees for doing so. To access the announcement on the TGA’s website, click here.