Australia and Medical Devices

All medical devices placed on the market in Australia must have a sponsor for the goods, resident in Australia, who takes responsibility for the products, compliance with regulatory obligations and any postmarket action, such as regulatory reporting to the TGA (Therapeutic Goods Authority), distribution, product recall, etc.

Here are a number of links to the TGA website:

Medical Devices home page - http://www.tga.gov.au/devices/devices.htm

Roles and responsibilities of medical device sponsors and manufacturers -

http://www.tga.gov.au/docs/html/devguid20.htm

Prior to you supplying medical devices in Australia, the device(s) must be entered on to the Australian Register of Therapeutic Goods (ARTG). This is done using an e-business account which a device sponsor establishes with the TGA, using the Devices Electronic Application Lodgement (DEAL) system established by the TGA.

Guidance on establishment of an e-business account and lodgement of applications can be found at - http://www.tga.gov.au/devices/dealfaq.htm#q7

The above document also has links to a number of other guidance documents, available from the website, which will provide you with further information on key elements of the regulatory framework and application process.

Fees are payable for most applications, and an annual fee is payable for each entry held by a sponsor on the ARTG.

Summary of fees and charges - http://www.tga.gov.au/fees/fees06.htm

Search the Australian Register of Therapeutic Goods

- https://www.tgasime.health.gov.au/SIME/ARTG/ARTGPublicWeb.nsf/DEVpublic?OpenView


PETER S. MERGUERIAN
peter@goglobalcompliance.com
GO GLOBAL COMPLIANCE, INC.
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