Australia | Tga Sponsor

Your TGA Sponsor in Australia

We facilitate the entry of your medical devices into the Australian market, ensuring compliance with TGA regulations.

If you are considering importing, manufacturing, or selling medical devices and IVDs in Australia, it is a legal requirement to appoint an Australian TGA sponsor to start the process.

CMC Medical Devices PTY LTD supports you as a TGA sponsor and regulatory consultant to ensure compliance with the technical requirements of TGA regulations and post-market compliance.

Product Registration

The TGA Sponsor service includes applying to the TGA to have your medical device and IVD registered in the Australian Register of Therapeutic Goods (ARTG) before commercialization.

Australia FSC

CMC can also apply for the Australian FSC (Free Sale Certificate) for any country worldwide, including country-specific legalisation.

Select CMC as Your TGA Sponsor in Australia

Complete the contact form and one of our consultants will get in touch as soon as possible.

    Why appoint CMC Medical Devices?

    Fast response

    We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

    Efficient communication

    Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

    Immediate support

    We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

    Quick resolution

    Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.