If software update for a medical device imported to KSA is released, but this update is only for improvement not due to a problem or malfunction in the device. Is it mandatory to inform SFDA about this action and provide all the requirements for its closure?
Question
If software update for a medical device imported to KSA is released, but this update is only for improvement not due to a problem or malfunction in the device. Is it mandatory to inform SFDA about this action and provide all the requirements for its closure?
Answer
In case there is a problem or malfunction affects patient or user’s safety, the manufacturer should issue the Field Safety Corrective Action and inform SFDA accordingly.
