Australian TGA Sponsor Representation for Medical Device Companies
An overseas manufacturer wishing to import and sell a medical device in Australia must register the device on the ARTG before selling in Australia.
A business that wants to sell in Australia but does not reside in Australia would need an in-country representation – TGA Sponsor (similar to Authorised Representative requirements in EU).
The main roles of a TGA Sponsor are to communicate with TGA, register the medical device on ARTG and act as a regulatory representative before and during commercialisation in Australia.
TGA requires Sponsor contact details to be stated on the package label and IFU.
A business that wants to sell in Australia but does not reside in Australia would need an in-country representation – TGA Sponsor (similar to Authorised Representative requirements in EU).
The main roles of a TGA Sponsor are to communicate with TGA, register the medical device on ARTG and act as a regulatory representative before and during commercialisation in Australia.
TGA requires Sponsor contact details to be stated on the package label and IFU.
How can we help:
We can act as your Australian Sponsor (TGA Sponsor) as required by Australian Therapeutic Goods (Medical Device) Regulations 2002.
As part of the Australian Sponsor services we provide the following:
As part of the Australian Sponsor services we provide the following:
- Device registration on the ARTG (Australian Register of Therapeutic Goods).
- Storing your technical file to make it available for TGA review upon request.
- Review of advertising materials, labels, and IFU before use.
- Represent the company in Australia as required by TGA, including adding MED QMS contact details on the device labels and IFUs.
- Assisting in reporting adverse events and recalls to TGA
Please contact us for further details.