Risk of Non-Compliance with Advertising and Labeling Requirements and Medical Device Regulations
First written in FY2025. 2 of 3 entries say "Mitigated", first in FY2025. Latest entry: 2026-07-01.
1 other company's latest entry also says "Mitigated".
- 2026-07-01MitigatedOther Disclosures
「By joining the association that established the voluntary standards, we will further study and deepen our expertise, including the management requirements under the Pharmaceuticals and Medical Devices Act, and contribute to the sound development of the industry.」
The company outlined its response to deepen expertise in voluntary medical-device standards and management under the Pharmaceuticals and Medical Devices Act through joining the Japan Medical Devices Manufacturers Association. - FY2025MitigatedAnnual report
「Following its acquisition of a Class II medical device marketing authorization in August 2024, the Company is progressively transitioning to filing notifications itself. In connection with obtaining this authorization, the Company appointed a safety management officer and is working to strengthen its safety management system for the marketing of general medical devices.」
In addition to internal reviews and training, the company is proceeding with the transition to self-reporting and the appointment of a safety management officer. - FY2025First statedAnnual report
「The Act against Unjustifiable Premiums and Misleading Representations is intended to prevent misleading representations regarding product quality and efficacy and to protect consumers. Accordingly, if the Company advertises the efficacy or performance of its products without clear supporting evidence, it may violate the Act.」
The Company cites internal reviews, legal and regulatory training, and cooperation with external organizations as its responses.