TGA IVD Sponsor Roadmap: Key Links & Steps for ARTG Inclusion

TGA (Australian Register of Therapeutic Goods) in Australia have updated a reference material called: “IVD sponsor: a roadmap to market“ dated 25th November with a new template and included additional content and links. 

The road map is applicable to the Australian sponsors of IVDs, providing the requirements for supplying the devices. A useful flow chart is provided by TGA presenting the steps before an IVD is included in the ARTG listing. 

The updated reference material consolidates the information required for sponsors to follow and understand the process of the application more clearly: 

TGA IVD Sponsor Roadmap: Key Links and Steps for ARTG Inclusion 

• • Links required for setting up an eBusiness services account.

• • Useful links in relation to information that a sponsor needs to obtain from the manufacturer, for example: 

• • •  IVD Classification

• • • GMDN Code

• • • Manufacturers Evidence

• • • Declaration of Conformity

• • • Conformity Assessment Procedure for IVDs

• • How to submit the IVD application through the eBusiness Services.

• • Information on application audits, including the types of high risk devices qualifying for a mandatory audit.

• • The ongoing responsibilities of the manufacturers and sponsors after ARTG inclusion. 

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This updated roadmap provides a clearer and more structured guide for Australian Sponsors navigating the IVD inclusion process in the ARTG. With the inclusion of detailed links, templates, and flowcharts, the TGA has streamlined access to essential information, ensuring sponsors are better equipped to meet regulatory requirements. For more details, visit the TGA’s official website or contact us so we can assist you. 

Learn how MedEnvoy can assist you:

• • • Australian TGA Sponsor
    • RA Consulting
    • QA Consulting