Could Non-medical Device Components Be Included In The Composition Components Of Active Medical Device?
2022-09-20
For the non-medical device components, they are not allowed to be submitted separately, but can be submitted as components of medical devices.
If this component is submitted as part of the medical device, it can be considered and evaluated as part of the whole device, and it should be inspected and verified together with the whole device. If administrative counterparts does not submit this component, or does not inspect or verify the component with the whole device, then it shall not be included in the product structure composition.
For example: Printers, Power supply cord, Fiber optic cables for endoscope, Connecting cables of neutral electrode, etc. They all belong to this situation.
