FAQ
FAQ
Is it required to provide a risk assessment form with each Field Safety Corrective Action?
Yes
If the manufacturer determines the time plan to implement the corrective action, does SFDA have the right to reduce the period if it deems it to be?
Yes, if SFDA deems that the plan provided by the manufacturer or the AR is too long, SFDA has the right to request deadline amendments.
If the Field Safety Notice was sent via e-mail, is receiving the e-mail sufficient for the notification?
No, the user's response must be provided to the sent email. The email address must be an official email for the healthcare provider.
What is the reference number meant in Statement Confirming Saudi Arabia is Not Affected form or Confirmation Statement for Completing the Field Safety Corrective Action form mentioned in the Guidance on Medical Device Field Safety Corrective Actions ?
The reference number of the Field Safety Notice on the NCMDR page, which begins with “mdprc” or Confirmation Code or the reference number of the authority where the Field Safety Notice is collected from .
Is it possible to extend the period of informing the customers for more than 5 working days if we have large number of affected users?
It is mandatory to respond to SFDA with the available justifications and procedures within the specified period, then the case and extension are evaluated according to the justifications and procedures presented.
Are text messages, WhatsApp messages, or other programs considered as an acceptable way to inform users of Field Safety Notice
No
If the corrective action includes destroying the affected devices, and the affected products were collected in the facility's warehouse, is it accepted to delay the destroying of the affected devices for some reasons (Some facilities destroy these products annually or semi-annually)
No, destroying the affected devices should be done according to the agreed plan.
What are the documents that SFDA has the right to request which support the closure process for Field Safety Corrective Actions?
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. 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.
What is the procedure if the medical device was supplied without telling the manufacturer?
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.