Prescription lenses: exempt medical devices

Prescription lenses supplied only for refractive correction are now exempt from the requirement for inclusion in the Australia Register of Therapeutic Goods (ARTG) prior to import, export or supply in Australia. This is whether they are supplied mounted (such as in spectacle frames) or unmounted. 

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.

Background

The previous regulations were interpreted and applied inconsistently at times. 

This change clarifies that prescription lenses are exempt medical devices.

More information

• Regulatory obligations for exempt medical devices
• Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024