Australia
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.



ARE YOU INTERESTED IN REGISTRATION 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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