Before any medical device can be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG) which is regulated by the Australian Therapeutic Goods Administration (TGA). Emergo, with its office in Sydney, can help you register your medical device or IVD with the TGA so you can start exporting your products into the Australian market.
Companies that have already acquired the European CE Marking for their medical devices will find the TGA process much easier since Australia recognizes the CE Marking. However, even if the medical device or IVD has CE Marking, it must still be registered with the TGA, and there is a mandatory audit for certain classes of products.
As part of our Australia TGA medical device registration services, we will:
- Assess the Australian TGA registration requirements for your device(s).
- Research the proper GMDN codes for your medical device(s).
- Conduct a Technical File review to ensure completeness.
- Assistance with compilation or review of clinical summary (a TGA requirement).
- File documentation with the TGA.
- Assess compliance with other regulatory requirements (prerequisite for TGA approval).
We can also act as your Australian Sponsor to the TGA. This is a mandatory requirement for medical device and IVD manufacturers who do not have a physical location within Australia.
To learn more about our medical device and IVD registration and approval services for Australia, please feel free to contact us.