Extended Commercialization and Approval Timelines for New Products and Technologies
First written in FY2016. 2 of 3 entries say "Restated". Latest entry: FY2023.
The whole theme swung hardest in 2026: 3 of 7 companies on the "Worse" side.
4 other companies' latest entry also says "Restated".
- FY2023RestatedAnnual report
「In overseas markets, the company must also meet the quality and testing standards specific to each country as a prerequisite for selling its products, and compliance may take longer than expected.」
The company continues to identify the risk that commercialization and product launches for new products may take longer due to compliance with medical device safety requirements, regulatory approvals and the quality standards of individual countries. - FY2017RestatedAnnual report
「In these processes, unexpected problems concerning efficacy or safety may be identified or arise, making it impossible to launch a new product when expected. … Approval may be delayed, not obtained, or the application may be voluntarily withdrawn, among other possibilities.」
The company continues to describe the risk that commercialization and product launches for new products may take longer due to medical device approvals, safety issues, clinical trials and overseas quality standards. - FY2016First statedAnnual report
「Unexpected problems concerning efficacy or safety may be identified or arise, making it impossible to launch a new product when expected. … Approval may be delayed, not obtained, or the application may be voluntarily withdrawn, among other possibilities.」
The company describes the risk that the launch of new products may be delayed or abandoned due to medical device approvals, clinical trials, safety issues, and quality and testing standards in overseas countries.