Australia
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY:
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.



Interested in obtaining fast market approval for your medical device or IVD in Australia? REQUEST A FREE QUOTE>

For more information on registration in Australia, check out the following article on our blog:
Country at a Glance: Australia
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