AUSTRALIA: Changes to ARTG's Inclusion Process for Non-Measuring, Non-Sterile Class I Medical Devices – July, 2021

• 2021-08-01 14:48:08

TGA's inclusion process for Class I in vitro diagnostic (IVD) medical devices in the Australian Register of Therapeutic Goods (ARTG) changed on 4 December 2020. This follows similar changes made on October 1, 2020, for Class I non-measuring, non-sterile medical devices. This article outlines the key changes about including Class I medical devices and Class 1 IVD medical devices in the ARTG.

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AUSTRALIA: Medical device inclusion process – June, 2021

• 2021-06-25 10:59:19

Any medical device (unless excluded or exempt under the Therapeutic Goods Act 1989) must be included in the Australian Register of Therapeutic Goods (ARTG) before it can be legally imported into, supplied within, or exported from Australia. This guidance is intended for sponsors applying for the inclusion of a 'kind of medical device', including IVD medical devices, in the ARTG.

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