Assist Overseas Manufacturers, based in Adelaide South Australia
ARTG Application to register or include medical device in the Australian Register of Therapeutic Goods (ARTG) need an Australian person or company to take legal responsibility for the application and be the official point of contact for TGA.
The Australian Therapeutic Goods (Medical Device) Regulations requires an Australian address to be associated with any in vitro diagnostic or medical device prior to inclusion on the ARTG.
EasiMed can provide your organisation with regulatory support, assisting your organisation to comply with Therapeutic Goods Administration requirements, and getting your device to market.
Our Solution
Manufacturers outside Australia are unable to be sponsor for their medical devices. We can be your Australian Sponsor and get your application underway.
- Acting as your medical device sponsor in Australia
- Prepare and sign all documents for the purposes of the medical device application
- Notify the manufacturer of any communications from TGA relating to the medical device or the medical device application
- Notify the manufacturer of TGA annual charges or other applicable fees and payment arrangement
- Transfer the sponsorship of the medical device on the manufacturer request
Supply your medical device on the Australian market
Once an ARTG inclusion is obtained, overseas manufacturer can start to supply your medical device on the Australian market with Australian sponsor who will ensure compliance with TGA requirements. We can assist you with the post sales service that is tailored to your requirement.
For further information please CONTACT us Today!
