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Regulation of medical devices

Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic devices, disinfectants, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, baby incubators, heart valves.

If you have an enquiry about medical devices that is not answered by this website, please see the contact details for medical devices enquiries.

Manufacturer

Manufacturers take full responsibility for the design and production of a medical device whether they make the device themselves or subcontract some of these activities. The name and address of the manufacturer always appears on the device label.

Health professional

Health professionals include doctors, psychologists, dentists, pharmacists, nurses, biomedical engineers, physiotherapists, practitioners of traditional Chinese medicine, osteopaths, and hospital administration.

Consumer

Consumers include patients, those managing their own health issues, and concerned members of the general public who are interested in the use of medical devices in Australia.