In Vitro Diagnostic (IVD) Registration in Australia
ANSWERED ON THIS PAGE:
- What is the Australia regulatory authority for IVDs?
- How are IVD devices classified in Australia?
- Must we submit a technical file to register our IVD in Australia?
Marketing an In Vitro Diagnostic (IVD) device in Australia requires approval by the Therapeutic Goods Administration (TGA) and registration in the Australian Register of Therapeutic Goods (ARTG).
With an office in Sydney, Emergo has the resources and expertise to fully support your IVD registration with the TGA. For companies with no local presence in Australia, Emergo can also serve as your Australian Sponsor in order to manage your IVD registration process and interact with the TGA on your behalf.
How the Australian TGA regulates IVD devices
The TGA has a classification system for IVD products separate from the regulator’s process for classifying medical devices. For IVD products, the TGA has a four-tier classification system (Class I, II, III and IV) based on perceived risk to users, public health or both.
IVD registration support with Australian TGA
Emergo has many years of experience assisting medical device and IVD companies register their products with the Australian TGA. Our TGA IVD registration service includes:
- Identifying the proper TGA classification for your IVD device
- Mapping out the proper regulatory pathway for your IVD
- Determining applicable TGA registration fees
- Reviewing your IVD Technical File
- Reviewing and/or conducting a risk assessment
- Compiling all necessary documentation and submitting to TGA on your behalf
We also help companies register their IVD devices in Europe and other markets.