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Medical devices are regulated by the Therapeutic Goods Administration (TGA) under the Ministry of Health.
Devices are classified according to risk following the EU model of Classes I, IIa, IIb, III and IV.
The approval process takes between 90 and 120 days.
An annual renewal fee is required.
An authorized representative is required to register medical devices in Australia.
Last updated on April 6, 2017.
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For more information on registration in Australia, check out the following article on our blog:
Country at a Glance: Australia