Before your device can be sold in Australia, it needs to be approved by the Therapeutic goods Administration (TGA), and listed on the Australian Register of Therapeutic Goods (ARTG). You will need an Australian sponsor, along with 24 hour contact phone numbers and you need to meet various obligations with regards to recalls, packaging and storage.
We can handle all this for you, with different packages to suit your needs.
Fixed Price Regulatory Analysis
Prior to commencing any filings, and running up large fees, let us conduct a fixed price analysis to let you know if there may be any problems gaining regulatory approval for your technology, what class of devices it will fall into, and whether the information and technical files you already have will be enough to get your device approved.
We’ll work out the quickest and cheapest way to get your product approved.
If your device is ready to be taken through the regulatory hurdles, we can complete and make all the necessary submissions and follow through with the TGA, making sure any potential issues are dealt with before they become unnecessary problems.
We can offer you Australian Sponsorship if required.