TGA Registration
The Therapeutic Goods Administration (TGA) requires that all medical devices and IVDs sold in Australia be included on the Australian Register for Therapeutic Goods (ARTG). We can assist with relevant product review, device classification and finally, device registration with the TGA.
Medical devices are classed based on the risk it poses to users or patients. As a starting point, you can use the tool provided by the TGA – What classification is my medical device?. This tool will give you a preliminary understanding of how your device is classed. We can further investigate using legislative tools and confirm the classification before making an application in the TGA. We can review all required technical documents from the manufacturer for all types of medical devices.
Our expertise includes registration of all classes of device, Class I, Class II and Class III.
Other classes of devices we can assist with include In-Vitro Diagnostic (IVD) e.g., Rapid Antigen Test Kits and Pregnancy Test kits.
Clinical Trials
Where clinical trials are required, our collaborators can assist with necessary medical writing, protocol writing and conducting the trials. We can write and review the Clinical Evaluation Reports in compliance with TGA, EU and USA regulations.
Clinical Evaluation Reports (CER)
All classes of medical device registered with the TGA requires a CER, including low-risk Class 1 devices. Our team of experts can write CER reports that are acceptable within many different global regulatory bodies.
Sponsor
It is mandatory for all devices to have an Australian-based sponsor with an ABN or ACN number. Manufacturers and distributors outside Australia are also required to have a sponsor that is Australian-based. R2 Pharma Solutions can provide sponsorship for certain devices and fulfill all sponsor obligations as per the TGA regulations.