SFDA must be informed of any duplicated Field Safety Notices and any updated information related to affected medical device or the corrective action.

Yes, it is allowed if they are made for the main medical device

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.

No, the user's response must be provided to the sent email. The email address must be an official email for the healthcare provider.

 No, destroying the affected devices should be done according to the agreed plan.

 Authorized Representative (AR) should respond to SFDA with any remarks and justifications within the specified period.

In case there is a problem or malfunction affects patient or user’s safety, the manufacturer should issue the Field Safety Corrective Action and inform SFDA accordingly.

No, KSA is considered not affected in this case. But in case SFDA inquires about these products, you must provide a statement confirming KSA is Not Affected by Field Safety Corrective Action.

Any affected device should not be imported until the corrective action is implemented and providing SFDA with supporting documents.