What are the documents that SFDA has the right to request which support the closure process for Field Safety Corrective Actions?
Answer
. Acknowledgement of the Authorized Representative (AR) to inform the users when the Field Safety Notice is issued, and the preventive and corrective actions related to it.
. Acknowledgement of the health care provider to complete the corrective action.
. Maintenance/service report.
. Any other document according to the type of the Field Safety Notice and the corrective action.
Question
What is the procedure if the medical device was supplied without telling the manufacturer?
Answer
The manufacturer is responsible for monitoring its medical devices, and informing users about any instructions for the safety or quality of the medical device. If there is any problem related to supplying or using the device, the manufacturer should inform the SFDA directly.
Question
Is it possible to provide risk assessment form from the manufacturer instead of the form mentioned in the Guidance on Medical Device Field Safety Corrective Actions?
Answer
No, it is necessary to fill out the risk assessment form in the guideline.
Question
"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
