What do I need to do to supply a medical device in Australia?
A person or company who is legally responsible for supplying a device in Australia is called a 'sponsor'.
Sponsors need to obtain from the manufacturer of the medical device/s, the:
- classification for the device/s
- GMDN codes for device/s.
The TGA requirements vary depending on the classification of the medical device.
For information on what a sponsor needs to do please refer to Obligations and responsibilities of medical device sponsors and manufacturers <http://www.tga.gov.au/docs/html/devguid20.htm.
Other information:
- An Overview of the New Medical Devices Regulatory System <http://www.tga.gov.au/docs/html/devguid1.htm> summarises the medical device legislation and includes a definition of a medical device.
- Information on the Regulation of other therapeutic goods (IVDs, tampons, disinfectants) <http://www.tga.gov.au/othertg/index.htm>.
- Details of the fees and charges payable <http://www.tga.gov.au/docs/html/feesach.htm>.
- Information on Access to unapproved therapeutic goods in Australia <http://www.tga.gov.au/docs/html/unapp.htm>.
Establishing an eBusiness account
Each company must have an eBusiness account with the TGA. Once a company has an eBusiness account, the administrator within the company can establish and maintain individual access for any staff within the company who require it.
If a company does not have a master account then they will need to establish an eBusiness account with the TGA. This is done on the TGA eBusiness website <http://www.ebs.tga.gov.au>.
Click on the New User section of the page and download the:
- Client Details Form - only to be completed if the company does not already have a CLIENT identification number. For first time sponsors, this form must be completed.
- EBusiness Access Form - needs to be completed to establish an eBusiness account with the TGA and to obtain an account name and password. Complete these forms and fax them to the TGA on 02 6232 8581. An account name and password will be sent to the email address specified on the form within three working days of the TGA receiving a correctly completed form.
Logging on
Applications are submitted via the TGA eBusiness website <http://www.ebs.tga.gov.au>.
User instructions
Once logged on, the user will be taken to the medical devices home page, which will provide a number of options.
User documentation
User documentation is available online or can be downloaded and printed. This document gives valuable information and assists in navigating through the various options available.