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TGA Sponsorship

From medical devices to health and beauty products, the Australian market often requires approval from the Therapeutic Goods Administration (TGA). We identify the regulatory requirements for your product range and, as your local TGA sponsor, pave the way for you to enter the Australian market in compliance with all legal requirements.

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Regulatory compliance in Australia: We manage your TGA sponsorship

Did you know that even toothpaste may be subject to TGA approval? Your health, wellness or beauty product may also be affected!

 

The Therapeutic Goods Administration (TGA) is responsible for the approval of medicines and medical devices in Australia. The definition of a therapeutic good is comprehensive, and many medical products, including complementary medicines, must be approved by the TGA before they can be imported into Australia and sold there.

 

Approval by the TGA is only possible through an Australian organisation or person, known as a sponsor. The sponsor assumes the role of the Market Authorisation Holder, as it is known in Europe, in relation to the TGA and is responsible for the product in the Australian market. International companies often use their distributors or trading partners as TGA sponsors, which can lead to conflicts of interest and dependencies. Appointing an independent third party as a TGA sponsor allows freedom in the choice of distribution partners and ensures that the sponsor acts in the best interests of the company.

 

Since 2025, AHK Australien has been registered as a sponsor with the TGA and can therefore represent your product on the Australian market. In addition to reliability and consistency in product sponsorship, we offer access to an excellent network of regulatory and legal experts who can assist you with your market entry for healthcare products. This service is ideal for companies that do not yet have a local presence in Australia but would like to sell their products on the local market.

 

We would be happy to provide you with a non-binding initial consultation on the scope of a TGA sponsorship agreement with us as your partner.

  • AHK Australien provided us with extremely competent support during the launch of direct sales of our medical products in Australia. The AHK team handled all the necessary steps for TGA registration professionally, promptly and in a focused manner. We value AHK's exceptional expertise and reliable communication as a dependable partner for our market development and look forward to continuing our collaboration.
    Hans-Gerd Groothold Head of Sales / Area Sales Manager Export
    Anita Dr. Helbig GmbH

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