How to get your medical device onto the ARTG
The Australian Register of Therapeutic Goods (ARTG) is the central point of control for the legal supply of therapeutic goods in Australia. Sponsors take responsibility for the supply of a medical device in or from Australia.
The Medical devices: a sponsor's roadmap to market <http://www.tga.gov.au/devices/devroadmap/index.htm> presents an overview of the requirements for including a medical device on the Australian Register of Therapeutic Goods.
- For information on what a sponsor needs to do please refer to the Australian Regulatory Guidelines for Medical Devices (ARGMD)
<http://www.tga.gov.au/devices/argmd.htm> - Establish an e-Business account with the TGA: TGA eBusiness Services
<http://www.ebs.tga.gov.au>
Other therapeutic goods
See: Other Therapeutic Goods (IVDs, tampons, disinfectants) <http://www.tga.gov.au/othertg/index.htm>
Fees & charges
See: Fees & payments <http://www.tga.gov.au/docs/html/feesach.htm>
Other useful information for Australian sponsors
- How to make a medical device application
<http://www.tga.gov.au/devices/dealfaq.htm> - What you need to do to supply a medical device in Australia
<http://www.tga.gov.au/devices/supplymd.htm> - Manufacturers' evidence required to support the application
<http://www.tga.gov.au/devices/fs_eccert.htm> - Further guidance for medical device sponsors
<http://www.tga.gov.au/devices/sponsors.htm>