Medical devices regulation basics

Related information

General information

  • What is a medical device?
    Medical devices are used on humans, have therapeutic benefits, have a physical effect on the body

Specific products

  • Alcohol wipes (regulation)
    The TGA regulates alcohol swabs according to the claims made by the manufacturer
  • Custom made medical devices
    Manufacturing of custom made devices must, at a minimum, meet conformity assessment procedures regulated by the TGA.
  • Electronic cigarettes
    The Australian Government is concerned about the use of electronic cigarettes in Australia, and the retail sale of electronic cigarettes containing nicotine is illegal.
  • Medical device/medicine 'boundary' products
    How antiseptic wipes, irrigation solutions, haemodialysis solutions and IVF media are regulated
  • Regulation of medical software and mobile medical 'apps'
    Software is becoming increasingly important in medical devices; however, its rapid evolution, particularly in relation to mobile technology, presents new and complex challenges for the TGA and regulatory agencies internationally.

Information for medical device sponsors