Device makers whose products include a drug component must obtain a Therapeutic Goods Administration (TGA) conformity assessment certificate before applying to register the device with the Australian Register of Therapeutic Goods (ARTG), according to a draft guidance.
Conformity assessment certificates obtained elsewhere cannot be substituted as a basis for inclusion in the ARTG, according to the TGA ruling.
The Australian Register of Therapeutic Goods (ARTG) was established under the Therapeutic Goods Act 1989.
The ARTG is a computer database of therapeutic goods. Therapeutic goods are divided broadly into two classes: medicines and medical devices.
Unless exempt, medicines must be entered as either 'registered' or 'listed' medicines and medical devices must be 'included' before they may be supplied in or exported from Australia.
The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.