What is SFDA procedure if some users do not respond to the Authorized Representative (AR) or the supplier? regarding a Field Safety Corrective Action?
Answer
If users are not responding to the Authorized Representative (AR) or the supplier in regards to implementing the corrective or preventive action and evidence is provided, the necessary actions will be taken to ensure safe use of the medical device.
Question
How long does the manufacturer or the Authorized Representative (AR) must keep the records proving implementing the Field Safety Corrective Actions?
Answer
According to requirements and standards of the approved quality management system in the manufacturer.
Question
Should the manufacturer standardize the contents of the Field Safety Notice so it includes all the contents (Annex (B))? of the guidelines for corrective actions for safety warnings for medical devices and products?
Answer
The Annex specifies the requested information in the Field Safety Notice, other information may be added by the manufacturer, according to the type of the problem and the corrective or preventive actions to reduce or remove a risk.
Question
Is it mandatory to submit the Field Safety Notice on the company’s account on NCMDR if it is received directly from SFDA via e-mail?
Answer
Yes, manufacturer through its Authorized Representative (AR) or importer shall report to the SFDA any Field Safety Corrective Action when the KSA is affected within (2) working days from Field Safety Corrective Action issuance date by manufacturer
Question
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.
