To place a medical device or IVD on the Australian market, non-Australian based manufacturers must appoint a local agent and obtain Therapeutic Goods Administration (TGA) certification. The TGA term for a local agent is a ‘sponsor’.
The sponsor’s role is to act on your behalf in all TGA related situations, including any compliance issues that may arise resulting from the sale of your products on the Australian market. The sponsor’s details must appear on product labelling or packaging.
While any Australian resident or registered business can play the role of a sponsor, it is prudent to select a sponsor familiar with TGA regulations. You need to know that you can rely upon your sponsor to react appropriately and within mandatory response times. KD&A can provide guidance to ensure your elected sponsor understands the requirements of Australian sponsors if required.
We are TGA agents who are expert on the Australian medical device and IVD market. With KD&A as your TGA agent, you can be confident that Australian regulatory compliance will be expertly managed and maintained.