"in the risk assessment form mentioned in the Guidance on Medical Device Field Safety Corrective Actions, is it possible to choose more than one option for the same standard?"
Answer
No, the higher standard must be chosen in case there is more than one option.
Question
Who should fill out the risk evaluation form? The manufacturer or Authorized Representative (AR) and the importer?
Answer
The manufacturer should fill out the risk assessment form
Question
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?
Answer
Authorized Representative (AR) should respond to SFDA with any remarks and justifications within the specified period.
Question
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.
