The AR shall assist the manufacturer in reporting any adverse event occurred outside the KSA for medical devices that are authorized to be placed on the KSA market. The report must explain the circumstances and provide information to NCMDR on the corrective action the manufacturer has taken or intends to take.
The acceptable grace period to send the response to the NCMDR is as follows:
| FSN’s Classification | Maximum Time to Send the Response |
| Very High Risk | 2 working days |
| High risk | 5 working days |
| Moderate Risk | 10 working days |
Manufacturers 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.
- Not later than (30) calendar days from the date of awareness for all adverse events, incidents, complaints which are not associated with high risks.
- If SFDA initiate a report of adverse event, incident, complaint, the response shall be received within (5) working days.
No applicable fee for NCMDR.
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