Ongoing licensing and regulatory approval risks related to dental laboratories and medical devices
First written in FY2023. 1 of 2 entries say "Restated". Latest entry: FY2024.
No other company in this theme has enough history to compare yet.
- FY2024RestatedAnnual report
「The Company recognizes the continuation of these licenses and other authorizations as one of the most important issues for the business and is taking appropriate measures. As of the filing date of this document, no factors preventing their continuation had arisen.」
The risk of discontinuation of the dental technician license, notification for the dental laboratory, and medical device-related licenses and permits is described, with no impediments as of the filing date. - FY2023First statedAnnual report
「The validity periods for these licenses and registrations are 6 years for the license to sell medical devices, 5 years for the license to market medical devices, and 5 years for the registration of a medical device manufacturing business. If the requirements for these licenses or other statutory requirements cease to be satisfied, the licenses may be revoked.」
The risk to business continuity if licenses, notifications or permits under the Dental Technicians Act and the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices are revoked is described. As of the filing date, no factors preventing business continuity had arisen.