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.

 In the event that the hospital refuses to enter the employee of the authorised representative to sign or deliver the document, the authorised representative must send an official letter explaining the case and the Field Safety Notice, through registered mail to the person in charge by the hospital but if the responsible person is not present at the hospital or refused to sign or receive the required document, the authorised representative employee must raise this case to the higher management inside the hospital.

No, you must first ensure that that none of the affected medical devices included in the Field Safety Notice  were imported and/or placed on the market and/or put into service in Saudi Arabia.

An email will be sent from the National Center for Medical Devices and Products Reports stating that the Field Safety Corrective Action has been closed.

* 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.

* Notification from the authorised representative to the distributor of the details of the problem and the required procedures and bearing full responsibility

* Follow-up in applying the corrective action

* Inform the SFDA of the updates with evidence of communication and follow-up 

A notification issued by the National Center for Medical Devices Reporting stating the risk associated with the medical device or product and the corrective actions to be taken; To avoid the risk associated with it.

if SFDA deems to  the necessity of conducting a study to evaluate the device, according to the frequency or severity of accidents, it may result in the addition of some conditions, which will inevitably be based on the methodology of risk analysis based on scientific foundations, and considering the best international practices.

Not necessarily, and regulatory bodies often take the manufacturer's recommendations into account in such cases, and it is not prohibited to add some requirements according to each case separately.