Medical devices are regulated by the Therapeutic Goods Administration (TGA) under the Ministry of Health. CLASSIFICATION SYSTEM:
Devices are classified according to risk following the EU model of Classes I, IIa, IIb, III and IV. TIMEFRAME:
The approval process takes between 90 and 120 days. LICENSE VALIDITY:
An annual renewal fee is required. AUTHORIZED REPRESENTATIVE:
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