- Medical Devices Marketing License is a formal authorization for manufacturing and distribution of medical devices.
- In particular, the First-Class Medical Devices Marketing License is an authorization that allows commercial companies to trade all grades of medical devices (Class I, II, III and IV) and needs to satisfy the strictest requirements.
- Medical Devices Manufacturing License is a formal authorization that is required for manufacturing activities of medical devices including machining, assembly and inspections.
- Saitama Plant is accredited for all manufacturing processes except for sterilization.