Medical Device Regulations and Prolonged Time to Commercialization
First written in FY2016. 8 of 9 entries say "Restated". Latest entry: FY2025.
The whole theme swung hardest in 2026: 3 of 7 companies on the "Worse" side.
4 other companies' latest entry also says "Restated".
- FY2025RestatedAnnual report
「The manufacture and sale of medical devices are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and regulatory review and approval may take a certain amount of time. Some medical devices also require clinical trials or similar procedures, and commercialization may take an extended period.」
Reiterates the risks of medical device regulation and longer commercialization timelines due to approvals and clinical trials. - FY2024RestatedAnnual report
「The manufacture and sale of medical devices are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and regulatory review and approval may take a certain amount of time. Some medical devices also require clinical trials or similar procedures, and commercialization may take an extended period.」
Reiterates the risks of medical device regulation, longer commercialization timelines due to approvals and clinical trials, and regulatory changes. - FY2022RestatedAnnual report
「The manufacture and sale of medical devices are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and regulatory review and approval may take a certain amount of time. Some medical devices also require clinical trials or similar procedures, and commercialization may take an extended period.」
Reiterates the risks of medical device regulation and longer commercialization timelines due to approvals and clinical trials. - FY2021RestatedAnnual report
「The manufacture and sale of medical devices are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and regulatory review and approval may take a certain amount of time. Some medical devices also require clinical trials or similar procedures, and commercialization may take an extended period.」
Reiterates the risks of medical device regulation, longer commercialization timelines due to approvals and clinical trials, and regulatory changes. - FY2020RestatedAnnual report
「The manufacture and sale of medical devices are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and regulatory review and approval may take a certain amount of time. Some medical devices also require clinical trials or similar procedures, and commercialization may take an extended period.」
Reiterates the risks of medical device regulation, longer commercialization timelines due to approvals and clinical trials, and regulatory changes. - FY2019RestatedAnnual report
「The manufacture and sale of medical devices are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and regulatory review and approval may take a certain amount of time. Some medical devices also require clinical trials or similar procedures, and commercialization may take an extended period.」
Reiterates the risks of medical device regulation, longer commercialization timelines due to approvals and clinical trials, and regulatory changes. - FY2018RestatedAnnual report
「The manufacture and sale of medical devices are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and regulatory review and approval may take a certain amount of time. Some medical devices also require clinical trials or similar procedures, and commercialization may take an extended period.」
Reiterates the risks of medical device regulation, longer commercialization timelines due to approvals and clinical trials, and regulatory changes. - FY2017RestatedAnnual report
「The manufacture and sale of medical devices are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and regulatory review and approval may take a certain amount of time. Some medical devices also require clinical trials or similar procedures, and commercialization may take an extended period.」
Reiterates the risks of medical device regulation and longer commercialization timelines due to approvals and clinical trials. - FY2016First statedAnnual report
「The manufacture and sale of medical devices are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and regulatory review and approval may take a certain amount of time. Some medical devices also require clinical trials or similar procedures, and commercialization may take an extended period.」
Identifies regulatory revisions and new regulations, as well as longer commercialization timelines due to approvals and clinical trials, as risks.