KD&A Sponsor Services allow international manufacturers to gain access the Australian market
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.
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.
Indicative Fee: AUD$2,012.50 per year
This annual fee will cover up to 15 medical devices.
Contact us if you require a custom quote.
Have a few questions? Visit our Frequently Asked Questions page.