Licence/Registration
Licence/Registration
【Osaki Office】
- In Vitro Diagnostics Marketing Authorization Holder License
- The Second Class Medical Devices Marketing Authorization Holder License
- In Vitro Diagnostics for animals Marketing Authorization Holder License
- ISO13485 certification
【Kawasaki Office】
- The manufacture of in vitro diagnostics
- The manufacture of in vitro diagnostics for animals
- The sales for highly controlled medical devices
- The wholesale distribution of pharmaceutical products
- The Wholesale distribution of pharmaceutical products for animals
- ISO13485 certification
- Registration of clinical laboratory
- CAP-LAP(College of American Pathologists Laboratory Accreditation Program) accreditation
- CLIA(Clinical Laboratory Inprovement Amendments) certification
Osaki and Kawasaki office are certified