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Do not differ, rather, it is the legal representative / The factory informs the authority in case of accidents and deaths in accordance with the announced reporting standards
No
Yes, it is mandatory
Yes it is
Five (5) working days, started from the date of informing the SFDA or the date of receiving an inquiry from SFDA regarding Field Safety Corrective Action.
Means an action taken by a manufacturer to reduce or remove a
risk of death or serious deterioration in the state of health
associated with the use of a medical device that is already placed
on the market.
The following are examples of these types of procedures:
• Checking the device to ensure that it is free from problems
• Repairing the device • Calibrating and adjusting device settings
• relabeling the device
• Destroying the device • Notifying patients about the problem of the device
means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat
No, the higher standard must be chosen in case there is more than one option.
* The authorized representative notifies the manufacturer of the Field Safety Corrective Action and provides a statement from the factory about the representative responsible for following up the Field Safety Corrective Action * The approved authorized representative clarifies the limits of his responsibilities according to the agreement with the manufacturer.