Quality Policy

List of Licenses (Certificates of Authorization)

Medical Devices for Human Use:
Unisis Corporation has acquired the following licenses from Japanese Ministry of Health, Labour and Welfare, as certificates of authorization;

First-Class Medical Devices Marketing License / Medical Devices Manufacturing License
(Saitama Plant, Unisis Corporation)

First-Class Medical Devices Marketing License / Medical Devices Manufacturing License (Saitama Factory, Unisis Corporation)
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.

Specially Controlled Medical Devices Sales License / Medical Devices Manufacturing License (Logistics/Sterilization Center, Unisis Corporation)

Specially Controlled Medical Devices Sales License / Medical Devices Manufacturing License (Logistics/Sterilization Center, Unisis Corporation)
Medical Devices Sales License is a formal authorization that is required for marketing activities of medical devices.
Medical Devices Manufacturing License is a formal authorization that is required for manufacturing activities of medical devices including machining, assembly and inspection. Logistics/Sterilization Center is accredited for all manufacturing processes of products including sterilization.

Medical Devices Manufacturing License (Hokkaido Plant, Unisis Corporation)

Medical Devices Manufacturing License (Hokkaido Plant, Unisis Corporation)
Medical Devices Manufacturing License is a formal authorization that is required for manufacturing activities of medical devices including machining, assembly and inspections.
Hokkaido Plant is accredited for all manufacturing processes except for sterilization.
Medical Devices for Veterinary Use:
Unisis Corporation has acquired the following licenses from Japanese Ministry of Agriculture, Forestry and Fisheries, as certificates of authorization;

Second-Class Medical Devices for Veterinary Use Marketing License /
Medical Devices for Veterinary Use Manufacturing License (Saitama Factory, Unisis Corporation)

Second-Class Medical Devices for Veterinary Use Marketing License / Medical Devices for Veterinary Use Manufacturing License (Saitama Factory, Unisis Corporation)
Medical Devices for Veterinary Use Marketing License is a formal authorization that is required for manufacturing and distribution activities of medical devices for veterinary use.
The Second-Class Medical Devices for Veterinary Use Marketing License allows commercial companies to trade Controlled Medical Devices for Veterinary Use and General Medical Devices for Veterinary Use.
Medical Devices for Veterinary Use Manufacturing License is a formal authorization that is required for manufacturing actvities of medical devices for veterinary use.

Medical Devices for Veterinary Use Manufacturing License
(Logistics/Sterilization Center, Unisis Corporation / Hokkaido Plant, Unisis Corporation)

Medical Devices for Veterinary Use Manufacturing License (Logistics/Sterilization Center, Unisis Corporation / Hokkaido Plant, Unisis Corporation) Medical Devices for Veterinary Use Manufacturing License (Logistics/Sterilization Center, Unisis Corporation/ Hokkaido Plant, Unisis Corporation)
Medical Devices for Veterinary Use Manufacturing License is a formal authorization that is required for manufacturing actvities of medical devices for veterinary use.