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What is a medical device?

Medical devices:

  • are used on humans
  • have therapeutic benefits
  • generally have a physical or mechanical effect on the body or are used to measure or monitor functions of the body.

Medical devices range from a bandage that you would put on a scratch to high risk products such as pacemakers that are implanted in your body.

Other examples of medical devices include:

  • artificial hips
  • blood pressure monitors
  • breast implants
  • catheters
  • condoms
  • lubricating eyedrops
  • MRI scanners
  • Orthodontics - eg braces, fillings
  • syringes
  • tongue depressors

From the Therapeutic Goods Act 1989...

41BD What is a medical device

  1. A medical device is:
    1. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
      1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
      2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
      3. investigation, replacement or modification of the anatomy or of a physiological process;
      4. control of conception;
      and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or
    2. an accessory to such an instrument, apparatus, appliance, material or other article.

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