Regulation of the Medical Device Business under the PMD Act
First written in FY2017. 2 of 3 entries say "Restated". Latest entry: FY2026.
The whole theme swung hardest in 2018: 1 of 7 companies on the "Worse" side.
7 other companies' latest entry also says "Restated".
- FY2026RestatedAnnual report
「The manufacture and sale of the Group's products, including electrolyzed hydrogen water generators for medical use and household electrical therapeutic devices, which are medical devices, are subject to regulation under the Act on Pharmaceuticals and Medical Devices.」
The regulatory risks under the Act on Pharmaceuticals and Medical Devices relating to the manufacture and sale of medical devices are being reaffirmed. - FY2021RestatedAnnual report
「The manufacture and sale of the Group's products, including electrolyzed hydrogen water generators for medical use and household electrical therapeutic devices, which are medical devices, are subject to regulation under the Act on Pharmaceuticals and Medical Devices.」
The regulatory risks under the Act on Pharmaceuticals and Medical Devices relating to the manufacture and sale of medical devices are being reaffirmed. - FY2017First statedAnnual report
「The manufacture and sale of the Group's products, including electrolyzed hydrogen water generators for medical use and household electrical therapeutic devices, which are medical devices, are subject to regulation under the Act on Pharmaceuticals and Medical Devices.」
The company identifies regulatory risks involving marketing authorization for medical devices, manufacturing authorization, notifications for sales locations, advertising regulations and other requirements.