| Theme | Maintenance and Repair of Dialysis Machines | |
|---|---|---|
| Title | Future trend concerning maintenance and repair services for medical devices in Japan | |
| Publish Date | 1997/04 | |
| Author | Hideo Takayanagi | Toray Industries, Inc. Pharmaceuticals and Medical Products Administration Dept |
| [ Summary ] | 1.According to the amendment of the Pharmaceutical Affairs Law in 1994, the following issues were clarified. 1) Repair licensing was authorized. 2) Medical industries should provide medical organizations with information for maintenance operations. 3) Medical organizations must execute maintenance operations in accordance with the above information. 2. According to the amendment of the Medical Law in 1996, the following issues were clarified. 1) Maintenance operations must be executed by the medical organization itself. 2) Maintenance operations can be executed by outside trust companies in the event that medical organization entrusts these tasks to such outside trust companies. 3) Authorized repair-licensing-companies can execute maintenance operations upon request by the medical organization. 3.Future trends in maintenance and repair services for medical devices in Japan. Both medical organizations and medical industry should execute necessary procedures for each task and should also cooperate and work together in order to meet the following goals. - Enhancement of safety - Development of medical technology - Pursuit of minimal medical treatment - Medical expense containment - Contribution to management |
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