Changes in legal regulations and certification requirements for products
First written in FY2017. 3 of 5 entries say "Restated". Latest entry: FY2025.
The whole theme swung hardest in 2020: 1 of 6 companies on the "Worse" side.
9 other companies' latest entry also says "Restated".
- FY2025RestatedAnnual report
「The Company's quality assurance division continues to monitor licensing and approval requirements and the legal environment on a daily basis, and recognizes that the possibility of these risks actually affecting the Group's performance is extremely low.」
The risk of changes in product regulations and certification requirements, and daily monitoring by the quality assurance division, continue to be described. - FY2023RestatedAnnual report
「The Company's quality assurance division continues to monitor licensing and approval requirements and the legal environment on a daily basis, and recognizes that the possibility of these risks actually affecting the Group's performance is extremely low.」
Continued monitoring of licensing, approval and certification requirements and the legal environment by the quality assurance division remains a response measure. - FY2020MitigatedAnnual report
「The Company's quality assurance division continues to monitor licensing and approval requirements and the legal environment on a daily basis, and recognizes that the possibility of these risks actually affecting the Group's performance is extremely low.」
Regarding legal and regulatory risks, the Company explicitly identified daily monitoring by the quality assurance division as a response measure and explained that the possibility of an actual impact on performance is extremely low. - FY2019RestatedAnnual report
「Violations of the relevant laws and regulations may result in administrative action, including the suspension or revocation of business licenses. In addition, if these regulations are changed in the future, this could affect the Group's performance.」
The risks associated with product licenses, approvals and certifications, administrative action for violations, and future regulatory changes continue to be described. - FY2017First statedAnnual report
「Violations of the relevant laws and regulations may result in administrative action, including the suspension or revocation of business licenses. In addition, if these regulations are changed in the future, this could affect the Group's performance.」
The Company identifies as risks the administrative action that may result from violations relating to the licenses, notifications and certifications required to manufacture and market medical equipment and similar products, as well as the impact of regulatory changes.