Regulatory Risk under the PMD Act Relating to Spectacle Lenses
First written in FY2024. 1 of 2 entries say "Restated". Latest entry: FY2026.
The whole theme swung hardest in 2026: 3 of 7 companies on the "Worse" side.
4 other companies' latest entry also says "Restated".
- FY2026RestatedAnnual report
「If a change in the classification of medical devices makes approval or certification by the Minister of Health, Labour and Welfare or a registered certification body necessary, and approval or certification is not obtained for any reason, this could hinder our principal business activities and affect the operating results and financial condition of our group.」
The risk of a change in the classification of eyeglass lenses and the need for approval or certification under the Pharmaceuticals and Medical Devices Act continues to be disclosed. - FY2024First statedAnnual report
「If a change in the classification of medical devices makes approval or certification by the Minister of Health, Labour and Welfare or a registered certification body necessary, and approval or certification is not obtained for any reason, this could hinder our principal business activities and affect the operating results and financial condition of our group.」
The risk of a change in classification and the resulting approval or certification requirements is identified on the assumption that eyeglass lenses qualify as general medical devices.