FAQs

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.

The local manufactures, the overseas manufactures, Authorized Representative, Importers, Distributors and the health practitioner must report incidents and adverse events to SFDA upon becoming aware it happens  

The appeal process to rejected shipments is published at:  (Click here)