Establishing an In-House System for Medical Device Registration, Manufacturing and Marketing
First written in FY2025. 2 of 3 entries say "Advanced", first in FY2025. Latest entry: 2026-07-01.
0 other companies' latest entry also says "Advanced".
- 2026-07-01AdvancedOther Disclosures
「In August 2024, we obtained a license to manufacture and market Class II medical devices (license number: 13B2X10608) and have established a structure under which we handle everything in-house, from obtaining clinical evidence through quality management (QMS) and safety management (GVP).」
The company outlined efforts to deepen its expertise in medical-device management through obtaining medical-device licenses and registrations and joining industry associations. - FY2025AdvancedAnnual report
「In addition, for recovery wear, we newly filed notifications for 4 materials used in household far-infrared blood circulation-promoting garments.」
The Company completed notifications for 4 new materials under its in-house medical device manufacturing and marketing structure. - FY2025First statedAnnual report
「Having obtained a license for Type 2 medical device manufacturing and marketing, the Company is now able to file notifications for General Medical Devices (Class I) and independently obtain certification registrations for Controlled Medical Devices (Class II).」
The Company states that it obtained the license in August 2024 and completed notifications for 8 products in February 2025.