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Medical devices

Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors and X-ray equipment. They generally have a physical or mechanical effect on the body, or are used to measure (or monitor) the body and its functions.


In vitro diagnostics (IVDs)

  • False-positive troponin results
    Given the sensitivity of modern troponin tests, health professionals should be alert to the potential for false positive results and the associated risk of unnecessary patient treatment

Implantable devices

Safety information

Importing and supplying

  • Custom made medical devices
    A health professional who imports or supplies a custom-made device, or obtains a custom-made device directly from the manufacturer for supply to their patient, will be a sponsor and have legal obligations under the Regulations
  • Importing & supplying medical devices
    The TGA regulates all medical devices that are imported into, supplied in or exported from Australia under the Therapeutic Goods Act 1989