Cancellation of Medical Device Approvals and Changes in Laws and Regulations
First written in FY2017. 2 of 4 entries say "Mitigated", first in FY2023. Latest entry: FY2026-H1.
The whole theme swung hardest in 2018: 1 of 7 companies on the "Worse" side.
2 other companies' latest entry also says "Mitigated".
- FY2026-H1MitigatedAnnual report
「Following approval by the Chinese regulatory authorities on 29 October 2025, we officially resumed sales in November of the same year.」
Regarding regulatory action in China following deficiencies in the product registration information, the disclosure states that approval was obtained from the Chinese regulatory authorities and sales resumed. - FY2025-H1MaterialisedAnnual report
「Because deficiencies were found in part of the product registration information filed with the regulatory authorities of the People's Republic of China, we decided to conduct a voluntary recall of the product. Following this decision, we are currently proceeding with the recall and filing an amendment application to correct the deficiencies in the product registration information.」
Risks relating to medical device registration and regulatory compliance have materialised in the form of deficiencies in product registration information, a voluntary recall and an amendment application. - FY2023MitigatedAnnual report
「At present, no event warranting cancellation of the relevant approval or licence has occurred. ... Through internal audits and other means, we conduct regular checks on compliance with relevant laws and regulations, quality management and related matters.」
The company states that no grounds for cancellation of approvals or licences have arisen at present and describes regular checks through internal audits and other means concerning relevant laws and regulations and quality management. - FY2017First statedAnnual report
「If such approvals or licences are cancelled because of violations of laws or regulations, the company may be required to recall products subject to regulation or discontinue their manufacture and sale. These actions could have a material effect on its business activities.」
The company has organised as new risks the potential cancellation of approvals and licences due to violations of the Pharmaceuticals and Medical Devices Act and other laws, the resulting product recalls and suspension of manufacturing and sales, and the impact of changes in laws and regulations, including overseas.