FAQs

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

If users are not responding to the Authorized Representative (AR) or the supplier in regards to implementing the corrective or preventive action and evidence is provided, the necessary actions will be taken to ensure safe use of the medical device.

According to requirements and standards of the approved quality management system in the manufacturer.

The Annex specifies the requested information in the Field Safety Notice, other information may be added by the manufacturer, according to the type of the problem and the corrective or preventive actions to reduce or remove a risk.

Manufacturers, Authorized Representative, Importers, Distributors shall report to the SFDA, upon becoming aware that adverse event, incident, a complaint has occurred, as follows: − Not later than (2) working days from the date of awareness, if the adverse event, incident, and complaint represent a serious public health threat. − Not later than (10) working days from the date of awareness if the adverse event, incident, complaint that results in an unanticipated death or unanticipated serious injury.