Regulatory Changes Relating to the Manufacture and Marketing of Contact Lenses
First written in FY2017. 4 of 6 entries say "Restated". Latest entry: FY2026.
Menicon moved to the "Worse" side of this theme in 2026.
The whole theme swung hardest in 2018: 1 of 7 companies on the "Worse" side.
1 other company's latest entry also says "Reframed".
- FY2026ReframedAnnual report
「To reduce these risks, our Group has established a dedicated department within the Corporate Headquarters and holds regular meetings to identify changes in the legal regulations of each country and report on them. We also share this information within the Production and Development Headquarters and reflect it in product development, seeking to contain increases in new product development periods, development costs, manufacturing costs and capital investment burdens.」
In the description of the monitoring and reporting structure for regulatory changes, the dedicated department was changed from being positioned within the Production and Development Headquarters to being positioned within the Corporate Headquarters, and information sharing with the development division was made explicit. - FY2023RestatedAnnual report
「To reduce these risks, our Group has established a dedicated department within the Production and Development Headquarters and holds regular meetings to identify changes in the legal regulations of each country and report on them.」
The Group continues to maintain a dedicated department to monitor regulations in each country and a regular reporting structure. - FY2022RestatedAnnual report
「To reduce these risks, our Group has established a dedicated department within the Production and Development Headquarters and holds regular meetings to identify changes in the legal regulations of each country and report on them.」
The Group continues to maintain a dedicated department and reporting structure to monitor regulatory changes and reflect them in product development. - FY2021RestatedAnnual report
「If new legal regulations governing the manufacture and sale of contact lenses are introduced in the future, or if the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices is amended, new measures may be required.」
The Group continues to disclose the risks of higher development, manufacturing and capital investment burdens resulting from the enactment or revision of laws and regulations governing contact lenses. - FY2019RestatedAnnual report
「If new legal regulations governing the manufacture and sale of contact lenses are introduced in the future, or if the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices is amended, new measures may be required.」
The Group continues to disclose the risk of the burden of responding to licensing, approval and regulatory changes affecting contact lenses as highly controlled medical devices. - FY2017First statedAnnual report
「If new legal regulations governing the manufacture and sale of contact lenses are introduced in the future, or if the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices is amended, new measures may be required. In such cases, the resulting longer development periods, higher development costs, higher manufacturing costs and greater capital investment burden could have a material effect on our Group’s financial position and operating results.」
Based on the licensing and approval framework for highly controlled medical devices, the Group discloses as risks the potential increases in development periods, costs and capital investment burdens resulting from future enactment or revision of laws and regulations.