Australia

The Therapeutic Goods Administration (TGA) department of the Australian department of Health regulates the marketing of medical devices in Australia. Most medical device manufacturers should obtain a TGA Conformity Assessment Certificate before the medical device can be included on the ARTG database and supplied in the Australian market. A very interesting exception are the medical device manufacturers that hold a European CE certificate, as based on agreements between Australia and Europe this could replace the TGA Certificate and give a direct entrance in the ARTG database. As always there are situations where the CE certificate will not be enough, but it is interesting enough to check the options first, especially if you are planning to market your product in both Europe and Australia.

Local license holder

Companies without an establishment in Australia are required to appoint an Australian local representative. Both the distributor as a separate Australian legal representative can act as the local partner. The local representative's name needs to be visible on your product or in your marketing material and distribution figures need to be shared with the Australian authorities through your local representative.

Language

All needs to be in English.

What can we do for you?

Registration support in Australia

 

Local independent license holding Australia

 

Check European Fast Track Routing for Australia

 

Registration support for Canada

 

Establishment license request Canada

 

 

Classification Check Canada

 

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