Medical device licensing and regulatory change risk
First written in FY2022. 2 of 4 entries say "Restated". Latest entry: FY2025.
The whole theme swung hardest in 2018: 1 of 7 companies on the "Worse" side.
8 other companies' latest entry also says "Restated".
- FY2025RestatedAnnual report
「As of the present time, no grounds for termination of licenses and approvals or factors hindering their continuation have arisen.」
The Company reconfirms that no factors have arisen that would result in the revocation of licenses and approvals or hinder their continued renewal. The validity periods of each license and approval are also disclosed. - FY2024RestatedAnnual report
「As of the present time, no grounds for termination of licenses and approvals or factors hindering their continuation have arisen.」
The Company reconfirms that no factors have arisen that would result in the revocation of licenses and approvals or hinder their continued renewal. - FY2023MitigatedAnnual report
「As of the present time, no grounds for termination of licenses and approvals or factors hindering their continuation have arisen.」
The Company states that, at present, no factors have arisen that would result in the revocation of licenses and approvals or hinder their continued renewal. - FY2022First statedAnnual report
「However, future amendments to laws or regulatory developments may result in additional costs for compliance measures. If licenses and approvals are revoked or their renewal is denied due to unforeseeable factors, business activities may be disrupted, which may affect the Company’s financial position, operating results and other aspects of its business.」
The Company identifies regulatory changes, costs of regulatory compliance, revocation of licenses and approvals, and denial of renewals as risks relating to medical device licenses and approvals.