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Are text messages, WhatsApp messages, or other programs considered as an acceptable way to inform users of Field Safety Notice FAQ

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? FAQ

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 ? FAQ

If the Field Safety Notice was sent via e-mail, is receiving the e-mail sufficient for the notification? FAQ

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? FAQ

Is it required to provide a risk assessment form with each Field Safety Corrective Action? FAQ

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? FAQ

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? FAQ

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? FAQ

If Field Safety Corrective Action is issued by the manufacture on specific serial or lot numbers, and these products with these numbers have not been imported into the KSA or put on the market, should we inform the SFDA about this Field Safety Corrective Action? FAQ

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