TGA Tightens Class I Device Registration Requirements

October 19, 2020

Australia’s Therapeutic Goods Administration (TGA) is now requiring manufacturers of Class I nonmeasuring, nonsterile devices to provide a declaration of conformity with their applications for listings on the Australian Register of Therapeutic Goods (ARTG).

If the TGA is satisfied a product meets all requirements after reviewing the application, it will include the device in the ARTG within four business days. If it isn’t satisfied that the product meets all requirements, it may conduct a nonmandatory audit.

The new requirement does not apply to Class I in vitro diagnostic devices or Class I export-only devices.

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