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 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.