Australian medical devices are any item used for the diagnosis, prevention, monitoring, or treatment of a disease, injury, or disability, as well as items for control of contraception. The majority of medical devices require pre-market approval and registration on the ARTG before they can be sold in Australia.
Different regulations apply, depending on the type of device being registered (for example, condoms are regulated differently than MRI scanners), but all applicants must hold evidence their device is safe and effective for its intended purpose. There are seven categories depending on the risk classification of the device, and the classification drives the amount of evidence required during a submission to the TGA. We can help identify the risk classification of the medical device and help with the application process, including assembly of the evidence package to support the safety and efficacy of the device.
NHP Consulting will provide all regulatory documentation to achieve market compliance for the Australian marketplace.