This article applies to selling in: Australia

Medical Devices and Accessories

Note: These product categories have not launched on Amazon.com.au and are not currently available to be sold. The information listed below is only to be used as a guide.

Examples of permitted listings for all sellers

Reminder: All listings and products must comply with all laws and regulations.
  • Eyeglass frames
  • Condoms
  • Bandages
  • Pregnancy tests
  • Thermometers

Examples of prohibited listings for all sellers

  • Products which have not been properly registered on the Australian Register for Therapeutic Goods (ARTG)
  • Products that have been altered to change the product's performance, safety specifications, or indications of use.
  • Products that the Food and Drug Administration (FDA) or Therapeutic Goods Administration (TGA) has determined present an unreasonable risk of injury or illness, such as:
    • Ear candles
    • Zappers
  • Products for which a premarket notification is required but has not yet been filed.
  • Products that have passed their expiration or "use by" dates.
  • Products labeled as "tester," "not for retail sale," or "not intended for resale".
  • Certain medical devices regardless of TGA or FDA clearance or approval, such as:
    • Hearing aids (with the exception of hearing aid accessories, which are permitted).
  • Products that are marketed as unapproved or unregistered medical devices, such as:
    • Psoriasis lamps.
  • Certain menstrual cups, such as:
    • Monzcare R-cup and LadyCup.
    • Rainbow and iCare menstrual cups.
  • Products that have been the subject of criminal enforcement, injunctions, seizures, or warning letters, such as:
    • Lelo LunaBeads and Tor II.
    • WaxVac Ear Cleaners.
  • Products that incorporate Class IIIB lasers (for example, laser light show projectors) and Class IV lasers (for example, industrial lasers).
  • Listings claiming that a product is intended to be used for the diagnosis, cure, mitigation, treatment, or prevention of disease in humans unless the claim is cleared or approved by the TGA, such as:
    • Chelation products, including metal detection test kits.
    • Miracle Mineral Solutions.
    • Rife Machines.
    • Sexually Transmitted Disease (STD) Test Kits.
  • Products that are adulterated or misbranded.
  • Electrical incontinence devices.
  • Ovulation tests.
  • Used and refurbished medical devices.

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