Compliance effective on 15 June 2024, prescription lenses for refractive correction are exempted from the requirement for inclusion in the Australia Register of Therapeutic Goods (ARTG) before import, export, and supply in Australia, including whether they are supplied mounted or unmounted.
However, this exemption does not include prescription lenses for treatment, instead, or in addition to corrective refraction.
This update means prescription lenses are not subjected to pre-market approval but are still required to comply with other regulatory obligations. While non-prescription spectacles are solely used for the magnification of images or sun protection, spectacle frames (without lenses) are excluded goods that are not categorized as therapeutic goods and are not regulated by the Therapeutic Goods Administration (TGA).
Contact us at info@arqon.com for more information.
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