In the event that a corrective action is issued by the factory, is it necessary for affected customers to be notified immediately even before the corrective plan is provided?
Answer
Yes, and they should be informed again if there are additional corrective or preventive recommendations or actions.
Question
In case of receiving inquiries from SFDA about a medical device Field Safety Corrective Action that they received from more than one source, but for the company is considered as one Field Safety Notice should all of them be closed, or it should be reported that they are the same Field Safety Notice which was previously answered?
Answer
SFDA must be informed of any duplicated Field Safety Notices and any updated information related to affected medical device or the corrective action.
Question
If a new Field Safety Corrective Action is issued and there is no affected device in KSA, but we as a manufacturer know that there is a request for a number of devices that will be available in the Kingdom (e.g. after two months), in this case, does KSA considered affected or not?
Answer
Any affected device should not be imported until the corrective action is implemented and providing SFDA with supporting documents.
Question
Is it required to provide a risk assessment form with each Field Safety Corrective Action?
Answer
Yes
Question
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?
Answer
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.
Question
If the Field Safety Notice was sent via e-mail, is receiving the e-mail sufficient for the notification?
Answer
No, the user's response must be provided to the sent email. The email address must be an official email for the healthcare provider.
Question
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 ?
Answer
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 .
Question
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?
Answer
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.
Question
Are text messages, WhatsApp messages, or other programs considered as an acceptable way to inform users of Field Safety Notice
Answer
No
Question
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)
Answer
No, destroying the affected devices should be done according to the agreed plan.
