Medical devices must be included on the TGA’s Australian Register of Therapeutic Goods (ARTG).
The level of pre-market regulatory submission required is determined by the inherent risk associated with the medical device. The complexity, duration & cost of the application is dependent upon the type of device, its classification, and if it has already undergone Conformity Assessment in the EU ( CE Mark).
We can conduct a product review, and advise on the appropriate TGA evaluation pathway, and the information requirements for your product.
Once product classification is confirmed, we can review documentation or assist in preparing and submitting applications to TGA.