As a authorised representative of a manufacturer I did not import the affected devices in the Field Safety Corrective Action , do I have to fill out the form “Statement Confirming Saudi Arabia is Not Affected by FSCA”?
Question
As a authorised representative of a manufacturer I did not import the affected devices in the Field Safety Corrective Action , do I have to fill out the form “Statement Confirming Saudi Arabia is Not Affected by FSCA”?
Answer
No, you must first ensure that that none of the affected medical devices included in the Field Safety Notice were imported and/or placed on the market and/or put into service in Saudi Arabia.
