Medical Device Registration with the Australian TGA
Before any medical device can be supplied in Australia, details must be included in the Australian Register of Therapeutic Goods (ARTG) which is regulated by the Australian Therapeutic Goods Administration (TGA). Emergo Asia Pacific Pty. Ltd., with offices in Sydney, Australia, can help you register your devices with the Australian TGA so you can get started exporting your products into the Australian and New Zealand markets.
As part of our medical device registration services for Australia, we will:
- Assess the TGA registration requirements for your device(s).
- Determine the proper classification of GMDN codes.
- Complete a Technical File review to ensure that it meets all necessary requirements.
- Assistance with establishing requirements for Clinical Evidence (a TGA requirement).
- File documentation with the TGA and follow up.
- Make payments of applicable fees to the TGA.
- Assess compliance with other regulatory requirements (prerequisite for TGA approval).
To learn more about our medical device registration services for Australia, please feel free to contact us.
