FAQ
FAQ
Who should fill out the risk evaluation form? The manufacturer or Authorized Representative (AR) and the importer?
The manufacturer should fill out the risk assessment form
If the Authorized Representative (AR) was unable to obtain a response to provide the corrective plan or ensure if the Kingdom is not affected within 5 working days, what is required and how is the response?
Authorized Representative (AR) should respond to SFDA with any remarks and justifications within the specified period.
What is SFDA procedure if some users do not respond to the Authorized Representative (AR) or the supplier? regarding a Field Safety Corrective Action?
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.
How long does the manufacturer or the Authorized Representative (AR) must keep the records proving implementing the Field Safety Corrective Actions?
According to requirements and standards of the approved quality management system in the manufacturer.
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?
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.
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?
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
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?
Yes, KSA is considered as not affected.
"What is the allowed period for submitting a corrective plan to implement Field Safety Corrective Action? "
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 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?
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.