Australia

Australia TGA Medical Device Registration

The Therapeutic Goods Administration (TGA) oversees all medical device regulations in Australia. Devices must be included in the Australian Register of Therapeutic Goods (ARTG) before commercialization. NKB Regovanta provides comprehensive regulatory strategies, conformity assessment support, and acts as your mandated Australian Sponsor.

Australia TGA Overview

Medical devices in Australia are regulated under the Therapeutic Goods Act 1989. The TGA utilizes a framework that aligns closely with the EU MDR, and frequently leverages international approvals (like CE Marking or MDSAP) to expedite the ARTG inclusion process.

Australian Sponsor Requirement

Foreign manufacturers MUST appoint an Australian Sponsor located within Australia. The Sponsor holds the ARTG inclusion and assumes strict legal liability for the device's compliance. NKB Regovanta provides reliable Sponsor services.

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