The Australian Therapeutic Goods (Medical Device) Regulations 2002 as amended requires an Australian address to be associated with any in vitro diagnostic or medical device (including where applicable software as a medical device) prior to inclusion on the ARTG.

KD&A can assist overseas manufacturers by providing Sponsor Services; acting as your organisation’s Sponsor in Australia. Your organisation can then use our address on your device’s instructions for use, labelling, and packaging.

KD&A can provide your organisation with regulatory support, assisting your organisation to comply with Therapeutic Goods Administration requirements, and getting your device to market.

For further information contact KD&A.