Medical Device Registration and Approval in Australia

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

Medical Device Regulations and Classification in 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.

For more information on Medical Device Registration in Australia, check out the following articles on blog!

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