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Saudi Arabia (KSA) - Medical Device Vigilance according to 93/42/CEE


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Hello everybody,

I have a vigilance-related question regarding the marketing of class IIb and III devices (according to 93/42/CEE) in the Kingdom of Saudi Arabia, and I am hoping that somebody may be able to shed some light on the topic.
After reading the FAQ section (“what should be reported”) of the Saudi Arabia's National Center for Medical Devices Reporting (NMCDR) website regarding the reportable events, it is still unclear:
  • Does the Manufacturer or Distributor have an obligation to report the adverse events to SFDA/NMCDR even if they have been deemed NOT related to the medical device?
  • If so, should only the adverse events that occurred in KSA be reported or even those that occurred outside the KSA?
It has come to my understanding that even when there is the “suspicion” that the medical device may have caused the adverse event (meaning that it was found in correlation or deemed related to the adverse events), the event should be reported to SFDA.

Could anybody please confirm this?
Thank you!
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