Prescription lenses: exempt medical devices

Prescription lenses: exempt medical devices

21 Jun 2024

These changes came into effect on 15 June 2024.

This is the case whether they include lens treatments. For example, anti-reflective coatings or sunglass colourings.

This exemption does not include prescription lenses for treatment, instead or in addition to corrective refraction, such as prescription lenses with peripheral optics control for slowing myopia progression in children. 

Non-prescription spectacles, when used solely for magnification of images or sun protection, are declared not to be therapeutic goods, and so not regulated by the TGA. 

Spectacle frames (without lenses) are also excluded goods, and not regulated by the TGA. 

What this change means

  • Prescription lenses for refractive correction are not subject to pre-market approval by the TGA, as they are exempt from the requirement to be listed in the Australian Register of Therapeutic Goods (ARTG). 
  • Other regulatory obligations still apply.

 

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