The TGA and Local Representative Requirements

The TGA and Local Representative Requirements

The Therapeutic Goods Administration (TGA) local representative (termed sponsor by the TGA) requirements can be a significant road block for non-Australian based manufacturers. KD&A can provide an effective and reliable solution.

To place a medical device or IVD on the Australian market, non-Australian based manufacturers must appoint a local agent and obtain 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. For further information regarding TGA sponsor requirements in Australia refer to the Australian Regulatory Guidelines for Medical Devices (ARGMD).

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.

Australian based KD&A are TGA experts who understand the Australian medical device and IVD market. With KD&A as your sponsor you can be confident that Australian regulatory compliance will be expertly managed and maintained.

To assist your organisation in complying with TGA requirements, KD&A is also available for regulatory support. Our expertise is in getting devices to market as efficiently as possible and we have many multi-national clients.

Contact us if you require a custom quote.