In case the products affected by the corrective action are related to specific serial numbers or lot numbers, Is KSA considered as not affected if the imported devices have different serial numbers or lot numbers?
Answer
Yes, KSA is considered as not affected.
Question
"What is the allowed period for submitting a corrective plan to implement Field Safety Corrective Action? "
Answer
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.
Question
In the event that the responsible person is not responding / present at the hospital to sign or receive the required document regarding Field Safety Corrective Action, what is the procedure taken for this case?
Answer
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.
Question
As a authorised representative of a manufacturer I did not import the affected devices in the Field Safety Corrective Action , do I have to fill out the form “Statement Confirming Saudi Arabia is Not Affected by FSCA”?
Answer
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.
Question
How do I make sure that the Field Safety Corrective Action has been closed?
Answer
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.
Question
"If the authorised representative of a manufacturer has a authorised representation certificate for devices classified with a specific classification, but the device affected by the Field Safety Corrective Action is not from the production line responsible for it even though it is of the same classification, is he responsible for closing the Field Safety Corrective Action for this device? "
Answer
* 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.
Question
What is required of the authorised representative in the event that the distributor (s) do not respond to him / her regarding the implementing of Field Safety Corrective Action?
Answer
* 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
Question
What is a Field Safety Notice?
Answer
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.
Question
When does SFDA set requirements for corrective actions for reported devices?
Answer
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.
Question
Does SFDA require corrective action for all reported incidents of medical devices and products?
Answer
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.
