Risk of responding to tighter medical device regulations
First written in FY2016. 3 of 4 entries say "Restated". Latest entry: FY2024.
The whole theme swung hardest in 2026: 3 of 7 companies on the "Worse" side.
4 other companies' latest entry also says "Restated".
- FY2024RestatedAnnual report
「The sale of medical devices is subject to various laws and regulations. In Japan, there is also a risk that administrative measures such as medical fee revisions every 2 years may affect the Company's profit or loss and financial condition. In addition, administrative measures related to the healthcare system in the United States may affect the profit or loss and financial condition of the Company's US subsidiary.」
Domestic medical fee revisions and administrative measures, as well as developments in the US healthcare system, continue to be described as risks that may affect profit or loss and financial condition. - FY2020RestatedAnnual report
「The sale of medical devices is subject to various laws and regulations. In Japan, administrative measures such as medical fee revisions every 2 years may affect the Company's profit or loss and financial condition. In addition, administrative measures related to the healthcare system in the United States may affect the profit or loss and financial condition of the Company's US subsidiary.」
Domestic medical fee revisions and US healthcare-related administrative measures are reiterated as regulatory and administrative trends that may affect profit or loss and financial condition. - FY2017RestatedAnnual report
「Medical devices in Japan are subject to various regulations under pharmaceutical and medical product administration. In addition, administrative policy trends concerning the healthcare system and health insurance, including reimbursement price revisions conducted every 2 years, may affect profit or loss and financial condition. Medical devices are similarly subject to various regulations overseas, and administrative policy trends related to healthcare systems and other matters may affect the profit or loss and financial condition of the Group.」
In addition to domestic regulations and reimbursement price revisions, overseas medical device regulations and healthcare systems are described as risks that may affect profit or loss and other financial metrics. - FY2016First statedAnnual report
「To ensure the efficacy and safety of pharmaceuticals, medical devices and other products, regulations based on the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Other Products (Pharmaceuticals and Medical Devices Act) are being strengthened consistently from manufacturing through sales and post-marketing safety measures. Accordingly, a prompt response to these tighter regulations is required.」
The strengthening of regulations is described as a future direction, with a prompt response identified as a challenge.