What are the documents that SFDA has the right to request which support the closure process for Field Safety Corrective Actions?
2024-02-20
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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.
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