Australia Market Access for Medical Device

REGULATORY AGENCY

• Department of Health, Therapeutic Goods Administration (TGA)

REGULATIONS

• Manufacturers are required to apply to include devices in the Australian Register of Therapeutic Goods (ARTG).
• All manufacturers of Class I (non-sterile and non- measuring) devices need to prepare a DoC and obtain a Certificate of Inclusion in the ARTG.
• Australian manufacturers of devices that fall in classes other than Class I (non-sterile and non-measuring), and foreign manufacturers of Class III and Class AIMB devices, require a Conformity Assessment Certificate from TGA and a DoC in order to be included in the ARTG.
• Foreign manufacturers of devices that fall in classes other than the above-mentioned – Class I (non-sterile and non-measuring), Class III and Class AIMD – require conformity assessment evidence from the TGA or an EU Notified Body, and a DoC, in order to be included in the ARTG.

GUIDELINES

• A local representative is required.
• The classification of a medical device determines the conformity assessment procedures manufacturers can choose to ensure that the device is adequately assessed.
• Higher classification devices must undergo more stringent conformity assessment procedures than lower classification devices.
• The conformity assessment procedures have been modelled on those developed by the Global Harmonisation Task Force (GHTF).

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